Regulatory

Behind the “Package Insert”: Loophole in FDA’s Regulation of Off-Label Prescriptions

Yolanda Li, MJLST Staffer

FDA Regulation of Drug Prescription Labeling and the “Package Insert”

Over the recent years, constant efforts have been made towards regulating medical prescriptions in an attempt to reduce risks accompanied with drug prescriptions. Among those efforts is the FDA’s revision of the format of prescription drug information, commonly known as the “package insert”.[1]

The package insert regulation, effective since 2006, applies to all prescription drugs. The package insert is to provide up-to-date information on the drug in an easy-to-read format. One significant feature is a section named “highlights”, which provides the most important information regarding the benefits and risks of a prescribed medication. The highlights section is typically half a page in length providing a concise summary of information including “boxed warning”, “indications and usage”, and “dosage and administration”.[2] The highlights section also refers physicians to appropriate sections of the full prescribing information. In this way, the package insert aims to draw both the physicians’ and the patients’ attention to the prescription of a drug, consequently accomplishing the ultimate purpose of managing medication use and reducing medical errors. Mike Leavitt, the Health and Human Services Secretary of the FDA commented that the package insert “help[s] ensure safe and optimal use of drugs, which translates into better health outcomes for patients and more efficient delivery of healthcare.”[3]

FDA Regulation of Off-Label Prescription and the Emergence of a Loophole

The FDA’s regulations relating to the labeling of prescription drugs, although systematic in its form, are cut short to a certain extent due to its lack of regulation on off-label prescriptions. Off-label prescriptions do not refer to a physician prescribing non-FDA approved drugs, a common misunderstanding by the public. Rather, off-label prescriptions are those that do not conform to the FDA-approved use set out in the FDA-approved label.[4] More specifically, off-label prescription generally refers to: “(1) the practice of a physician prescribing a legally manufactured drug for purposes other than those indicated on that drug’s FDA mandated labeling; (2) using a different method of applying the treatment and prescribing a drug, device, or biologic to patient groups other than those approved by FDA; and (3) prescriptions for drug dosages that are different from the approved label-recommended dosage or for time periods exceeding the label-recommended usage.”[5] For example if Drug A’s use, as mandated by the FDA, is to treat chronic headaches, and a physician prescribes it to treat a patient’s sprained ankle, that is an off-label prescription. However, such practice is common as estimated by the American Medical Association (AMA).[6]

The commonly approach is that the FDA and courts do not to interfere with physicians’ off-label uses.[7] Thus, when the FDA regulates the labeling of approved uses but does not regulate prescriptions for off-label uses, a loophole is formed. Andrew von Eschenbach, M.D., claims that because the FDA’s package insert regulation makes it easier for physicians to get access to important information about drugs, including drug safety and benefits, this regulation helps physicians to have more meaningful discussions with patients.[8] However, physicians’ discretion in prescribing off-label prescriptions would offset the proposed benefit of the FDA regulation because the regulation remains as guidance without force of law once physicians choose to go off from FDA’s approved uses of drugs. The easy-to-understand feature of the package insert and its benefit for a patient’s understanding of the drug becomes futile when physicians exercise discretion and prescribe drugs for uses not written on the inserts. In sum, when a patient receives an off-label prescription, the insert provides them little benefit as it addresses benefits and risks related to a different use of the drug.

It is undisputed that drug manufacturers have less discretion regarding drug labeling than physicians. If a manufacturer included an off-label use on a drug’s label, and promoted the off-label use of the drug, the drug would be considered misbranded. The manufacturer would then be subject to liability[9] as manufacturing a misbranded product in interstate commerce is prohibited.[10] However, the effect of regulations on manufacturers still fail to eliminate the loophole in off-label prescription: in response to the regulations, the manufacturer usually receives FDA approval for only a few drug uses and then relies on physicians prescribing off-label uses to ensure their profitability.[11] In this way, the manufacturer avoids liability under regulation and furthers the loophole in off-label prescription by encouraging physicians to prescribe more off-label uses in order to expand the manufacturer’s market.[12]

Why are Off-Label Prescriptions Difficult to Regulate?

One of the main reasons behind the lack of regulation of off-label prescriptions is the FDA’s objective in ensuring effective delivery of health care. Physicians are encouraged to use discretion and judgment in order to tailor prescription to patients’ individual conditions.[13] Another reason is to increase efficiency in treatments by avoiding the lengthy FDA approval process.[14] Aspirin was widely prescribed to reduce the risk of heart attack long before it was FDA-approved for this purpose; off-label prescriptions have also been proven effective in treatment of cancer, and off-label therapies have prolonged the lives of AIDS patients.[15] Another concern is drug prices in the United States, and promoting off-label uses has been found to help reduce drug prices as increased sales volume enables drug companies to lower their prices.[16] Indeed, off-label prescription has become a mainstream of medicine: “the FDA has long tolerated off-label drug use and has disclaimed any interest in regulating physicians’ prescribing practices.”[17] Today it is unclear whether the agency even has jurisdiction to regulate off-label prescription of drugs.[18]

In sum, there is clear guidance on the labeling of prescription drugs as a result of FDA regulation. However, because of difficulties in enforcement, the custom and widely accepted practice of off-label prescriptions and the inherent benefit of off-label prescription, the effects of the regulation are not as effective as what was firstly planned and proposed.

Notes

[1] The FDA Announces New Prescription Drug Information Format, U.S. Food & Drug Adm’ (Dec. 04 2015) https://www.fda.gov/drugs/laws-acts-and-rules/fda-announces-new-prescription-drug-information-format.

[2] Id.

[3] Id.

[4] Margaret Z. Johns, Informed Consent: Requiring Doctors to Disclose Off-Label Prescriptions and Conflicts of Interest, 58 Hastings L.J. 967, 968 https://plus.lexis.com/document?crid=35364c11-2939-4e58-bceb-dab7ae8f0154&pddocfullpath=%2Fshared%2Fdocument%2Fanalytical-materials%2Furn%3AcontentItem%3A4P0W-GY20-00CW-906B-00000-00&pdsourcegroupingtype=&pdcontentcomponentid=7341&pdmfid=1530671&pdisurlapi=true.

[5] Lisa E. Smilan, The off-label loophole in the psychopharmacologic setting: prescription of antipsychotic drugs in the nonpsychotic patient population, 30 Health Matrix 233, 240 (2020), https://plus.lexis.com/document/?pdmfid=1530671&crid=367cf8ad-295e-4f14-97fa-737618718d61&pddocfullpath=%2Fshared%2Fdocument%2Fanalytical-materials%2Furn%3AcontentItem%3A64BT-RR31-JWBS-61KV-00000-00&pdworkfolderid=5506aeec-9540-4837-89f0-5a1acfd81d8b&pdopendocfromfolder=true&prid=1d42abd0-b66e-43af-a61a-0d1fb94180f5&ecomp=gdgg&earg=5506aeec-9540-4837-89f0-5a1acfd81d8b#.

[6] Supra note 4.

[7] Sigma-Tau Pharms. v. Schwetz, 288 F.3d 141, 148, https://plus.lexis.com/document?crid=7d2a2b00-13ad-4953-968e-82a28724aa00&pddocfullpath=%2Fshared%2Fdocument%2Fcases%2Furn%3AcontentItem%3A45RF-5H50-0038-X1PB-00000-00&pdsourcegroupingtype=&pdcontentcomponentid=6388&pdmfid=1530671&pdisurlapi=true.

[8] Supra note 1.

[9] 21 CFR 201.5, https://plus.lexis.com/document/?pdmfid=1530671&crid=e02a99fb-be65-4525-b83c-a167f3e21b93&pddocfullpath=%2Fshared%2Fdocument%2Fadministrative-codes%2Furn%3AcontentItem%3A603K-BXD1-DYB7-W30Y-00000-00&pdcontentcomponentid=5154&pdworkfolderlocatorid=NOT_SAVED_IN_WORKFOLDER&prid=ff2b7e20-9dab-49b0-8385-627c16ee0ba2&ecomp=vfbtk&earg=sr2.

[10] 21 CFR 801.4, https://plus.lexis.com/document/?pdmfid=1530671&crid=721a586d-52a4-4228-b0c3-c464a77d6e6a&pddocfullpath=%2Fshared%2Fdocument%2Fadministrative-codes%2Furn%3AcontentItem%3A638R-X4S3-GXJ9-32FV-00000-00&pdcontentcomponentid=5154&pdworkfolderlocatorid=NOT_SAVED_IN_WORKFOLDER&prid=ff2b7e20-9dab-49b0-8385-627c16ee0ba2&ecomp=vfbtk&earg=sr6.

[11]  Supra note 4.

[12] Id.

[13]   Supra note 7.

[14]   Supra note 4.

[15]  Id.

[16] Supra note 4, at 981.

[17] ​​Kaspar J. Stoffelmayr, Products Liability And “Off-label” Uses Of Prescription Drugs, 63 U. Chi. L. Rev. 275, 279, https://plus.lexis.com/document?crid=a2181ffc-7f3e-4bce-b82e-08ba9111194f&pddocfullpath=%2Fshared%2Fdocument%2Fanalytical-materials%2Furn%3AcontentItem%3A3S3V-4CF0-00CV-K03W-00000-00&pdsourcegroupingtype=&pdcontentcomponentid=7358&pdmfid=1530671&pdisurlapi=true.

[18]  Id.


New Congressional Bill to Fuel the Crypto Winter?

Shawn Zhang, MJLST Staffer

Cryptocurrency has experienced rapid growth over the past few years. Retail investors rushed into this market in hopes of amassing wealth. However, the current price of Bitcoin is sitting at roughly 30% of the all-time high. Investors dub this current state of the market as the “Crypto Winter”, where the entire crypto market is underperforming. This term signifies the current negative sentiment held by a large portion of the market towards cryptocurrency.

Cryptocurrency is a relatively new class of assets, bearing similarities to both currency and securities. Regulators are not quite sure of how to regulate this volatile market, and with the lack of regulations investors are more prone to risk. Nevertheless, legislators are still seeking to protect retail investors and the general public from risky investments, as they did with the 1933 Securities Act and 1934 Securities Exchange Act. The question is how? Well, the answer may be The Lummis-Gillibrand Responsible Financial Innovation Act which has recently been introduced into Congress. This bill seeks to “provide for responsible financial innovation and to bring digital assets within the regulatory perimeter.” If passed, this bill would address those concerns investors currently have with investing in the volatile crypto market.

Summary of the Bill

This legislation would set up the regulatory landscape by granting the Commodity Futures Trading Commission (CFTC) exclusive jurisdiction over digital assets, subject to several exclusions. One of the exclusions being that when the asset is deemed a security, the Securities and Exchange Commission (SEC) will gain jurisdiction and providers of digital asset services will then be required to provide disclosures. The bill would also require the Internal Revenue Service to issue regulations clarifying issues of digital assets and eliminate capital gains taxes through a de minimis exclusion for cryptocurrencies used to buy up to $200 of goods and services per transaction. Moreover, it would also allow crypto miners to defer income taxes on digital assets earned while mining or staking until they dispose of the assets.

Commodity vs Security

So, what’s the difference between CFTC and SEC? The CFTC governs commodities and derivatives market transactions, while the SEC governs securities. The key difference that these classifications make are the laws under which they operate. The CFTC was created under the 1936 Commodities Exchange Act, while the SEC was created under the 1933 Securities Act and 1934 Securities Exchange Act. Hence, giving the CFTC primary jurisdiction means that cryptocurrency will primarily be governed under the 1936 Commodity Exchange Act. The biggest advantage (or what one may think of as a disadvantage) of this Act is that commodities are generally more lightly regulated than securities. Under the 33’ act and 34’ act, securities are thoroughly regulated via disclosures and reports to protect the public. Issuers of securities must comply with a large set of regulations (which is why IPOs are expensive). This could be a win for crypto, as crypto was intended to be “decentralized” rather than heavily regulated. Though having some regulations may help invoke public trust in this class of assets and potentially increase the total number of investors, which may be a bigger win.

The question ends up being what level of regulation and protection is appropriate? On the one hand, applying heavy handed regulations may not be effective, and in fact might encourage black market activity. This may lead to tech savvy investors detaching their real life identity from the world of crypto and using their money elsewhere through the blockchain networks. On the other hand, investors hate uncertainty. Markets react badly when there is “fear, uncertainty, and doubt.” By solidifying the jurisdiction of CFTC on cryptocurrency, both investors and issuers may feel more at ease rather than wonder what regulations they must follow. As a comparison, oil, gold, and futures are also regulated by the CFTC rather than the SEC, and they seem to be doing fine on the exchanges.

Tax Clarifications & Incentives

Clarifications are always welcome in the complex world of federal taxes. Uncertainty can result in investors avoiding a class of assets purely due to the complexity of its tax consequences. Moreover, investors may be unexpectedly hit with a tax bill that was different from what they expected due to ambiguity or lack of clarity in the statutes. Thus, clarifications under the proposed Act would likely make lives easier for investors in this space.

Tax often incentivizes certain investor actions. For example, capital gains tax incentivizes investors to hold their investments for longer than a year in order to reduce their taxes. Tax incentives also often have policy rationales behind them, like the capital gain tax incentive aims to promote long term investment rather than short term speculation. This indirectly protects investors from short term fluctuations in the market, and also keeps more money in the economy for longer.

The proposed Act would eliminate capital gains tax for crypto used to purchase goods and services up to $200. That’s $200 of untaxed money that could be spent without increasing an investor’s tax liability. This would likely encourage people to conduct at least some transactions in crypto, and thus further legitimize the asset class. People often doubt the real world use of cryptocurrencies, but if this Act can encourage people to utilize and accept cryptocurrencies in everyday transactions, it may increase confidence in the asset class.

Conclusion

The Lummis-Gillibrand Responsible Financial Innovation Act could be a big step towards further adoption and legitimization of crypto. Congress giving primary jurisdiction to the CFTC is likely the better choice, as it strikes a balance between protecting consumers while not having too much regulation. Regardless of whether this will have a positive impact on the current market or not, Congress is at least finally signaling that they do see Crypto as a legitimate class of asset.


It’s Social Media – A Big Lump of Unregulated Child Influencers!

Tessa Wright, MJLST Staffer

If you’ve been on TikTok lately, you’re probably familiar with the Corn Kid. Seven-year-old Tariq went viral on TikTok in August after appearing in an 85-second video clip professing his love of corn.[1] Due to his accidental viral popularity, Tariq has become a social media celebrity. He has been featured in content collaborations with notable influencers, starred in a social media ad for Chipotle, and even created an account on Cameo.[2] At seven-years-old, he has become a child influencer, a minor celebrity, and a major financial contributor for his family. Corn Kid is not alone. There are a growing number of children rising to fame via social media. In fact, today child influencers have created an eight-billion-dollar social media advertising industry, with some children generating as much as $26 million a year through advertising and sponsored content.[3] Yet, despite this rapidly growing industry, there are still very few regulations protecting the financial earnings of children entertainers in the social media industry.[4]

What Protects Children’s Financial Earnings in the Entertainment Industry?

Normally, children in the entertainment industry have their financial earnings protected under the California Child Actor’s Bill (also known as the Coogan Law).[5] The Coogan Law was passed in 1939 by the state of California in response to the plight of Jackie Coogan.[6] Coogan was a child star who earned millions of dollars as a child actor only to discover upon reaching adulthood that his parents had spent almost all of his money.[7] Over the years the law has evolved, and today it upholds that earnings by minors in the entertainment industry are the property of the minor.[8] Specifically, the California law creates a fiduciary relationship between the parent and child and requires that 15% of all earnings must be set aside in a blocked trust.[9]

What Protections do Child Social Media Stars Have? 

Social media stars are not legally considered to be actors, so the Coogan Law does not apply to their earnings.[10] So, are there other laws protecting these social media stars? The short answer is, no. 

Technically, there are laws that prevent children under the age of 12 from using social media apps which in theory should protect the youngest of social media stars.[11] However, even though these social media platforms claim that they require users to be at least thirteen years old to create accounts on their platforms, there are still ways children end up working in content creation jobs.[12] The most common scenario is that parents of these children make content in which they feature their children.[13] These “family vloggers” are a popular genre of YouTube videos where parents frequently feature their children and share major life events; sometimes they even feature the birth of their children. Often these parents also make separate social media accounts for their children which are technically run by the parents and are therefore allowed despite the age restrictions.[14] There are no restrictions or regulations preventing parents from making social media accounts for their children, and therefore no restriction on the parents’ collection of the income generated from such accounts.[15]

New Attempts at Legislation 

So far, there has been very little intervention by lawmakers. The state of Washington has attempted to turn the tide by proposing a new state bill that attempts to protect children working in social media.[16] The bill was introduced in January of 2022 and, if passed, would offer protection to children living within the state of Washington who are on social media.[17] Specifically, the bill introduction reads, “Those children are generating interest in and revenue for the content, but receive no financial compensation for their participation. Unlike in child acting, these children are not playing a part, and lack legal protections.”[18] The bill would hopefully help protect the finances of these child influencers. 

Additionally, California passed a similar bill in 2018.[19] Unfortunately, it only applies to videos that are longer than one hour and have direct payment to the child.[20] What this means is that a child who, for example, is a Twitch streamer that posts a three-hour livestream and receives direct donations during the stream, would be covered by the bill; however, a child featured in a 10-minute YouTube video or a 15-second TikTok would not be financially protected under the bill.

The Difficulties in Regulating Social Media Earnings for Children

Currently, France is the only country in the world with regulations for children working in the social media industry.[21] There, children working in the entertainment industry (whether as child actors, models, or social media influencers) have to register for a license and their earnings must be put into a dedicated bank account for them to access when they’re sixteen.[22] However, the legislation is still new and it is too soon to see how well these regulations will work. 

The problem with creating legislation in this area is attributable to the ad hoc nature of making social media content.[23] It is not realistic to simply extend existing legislation applicable to child entertainers to child influencers[24] as their work differs greatly. Moreover, it becomes extremely difficult to attempt to regulate an industry when influencers can post content from any location at any time, and when parents may be the ones filming and posting the videos of their children in order to boost their household income. For example, it would be hard to draw a clear line between when a child is being filmed casually for a home video and when it is being done for work, and when an entire family is featured in a video it would be difficult to determine how much money is attributable to each family member. 

Is There a Solution?

While there is no easy solution, changing the current regulations or creating new regulations is the clearest route. Traditionally, tech platforms have taken the view that governments should make rules and then they will then enforce them.[25] All major social media sites have their own safety rules, but the extent to which they are responsible for the oversight of child influencers is not clearly defined.[26] However, if any new regulation is going to be effective, big tech companies will need to get involved. As it stands today, parents have found loopholes that allow them to feature their child stars on social media without violating age restrictions. To avoid these sorts of loopholes to new regulations, it will be essential that big tech companies work in collaboration with legislators in order to create technical features that prevent them.

The hope is that one day, children like Corn Kid will have total control of their financial earnings, and will not reach adulthood only to discover their money has already been spent by their parents or guardians. The future of entertainment is changing every day, and the laws need to keep up. 

Notes

[1] Madison Malone Kircher, New York Times (Online), New York: New York Times Company (September 21, 2022) https://www.nytimes.com/2022/09/21/style/corn-kid-tariq-tiktok.html.

[2] Id.

[3] Marina Masterson, When Play Becomes Work: Child Labor Laws in the Era of ‘Kidfluencers’, 169 U. Pa. L. Rev. 577, 577 (2021).

[4] Coogan Accounts: Protecting Your Child Star’s Earnings, Morgan Stanley (Jan. 10, 2022), https://www.morganstanley.com/articles/trust-account-for-child-performer.

[5] Coogan Law, https://www.sagaftra.org/membership-benefits/young-performers/coogan-law (last visited Oct. 16, 2022).

[6] Id.

[7] Id.

[8] Cal. Fam. Code § 6752.

[9] Id.

[10] Morgan Stanley, supra note 4.

[11] Sapna Maheshwari, Online and Making Thousands, at Age 4: Meet the Kidfluencers, N.Y. Times, (March 1, 2019) https://www.nytimes.com/2019/03/01/business/media/social-media-influencers-kids.html.

[12] Id.

[13] Id.

[14] Id.

[15] Id.

[16] Katie Collins, TikTok Kids Are Being Exploited Online, but Change is Coming, CNET (Aug. 8, 2022 9:00 AM), https://www.cnet.com/news/politics/tiktok-kids-are-being-exploited-online-but-change-is-coming/.

[17] Id.

[18] Id.

[19] E.W. Park, Child Influencers Have No Child Labor Regulations. They Should, Lavoz News (May 16, 2022) https://lavozdeanza.com/opinions/2022/05/16/child-influencers-have-no-child-labor-regulations-they-should/.

[20] Id.

[21] Collins, supra note 19.

[22] Id.

[23] Id.

[24] Id.

[25] Id.

[26] Katie Collins, TikTok Kids Are Being Exploited Online, but Change is Coming, CNET (Aug. 8, 2022 9:00 AM), https://www.cnet.com/news/politics/tiktok-kids-are-being-exploited-online-but-change-is-coming/.


Making Moves on Marijuana: President Biden and Minnesota Update Marijuana Laws in 2022

Emma Ehrlich, MJLST Staffer

Federal Pardoning 

Earlier this month, President Biden announced that he would be pardoning anyone with a federal conviction due to simple marijuana possession charges. This will affect approximately 6,500 people on the federal level, plus thousands of others who were convicted in the District of Columbia. However, this pardon does not cover anyone involved in the actual sale of marijuana or anyone convicted under state possession laws, meaning it affects only a subsection of those who have been convicted of marijuana related charges. The administration’s goal was to give a clean slate to those who were struggling to find housing or employment due to a possession charge, and to encourage state legislatures to do the same. 

The second half of President Biden’s announcement was to task the Attorney General with reviewing the federal government’s categorization of marijuana as a Schedule 1 drug, which President Biden pointed out is currently the same categorization as heroin. Drugs are supposed to be assigned to schedules based on their medical uses and addictive qualities. The Drug Enforcement Agency (“DEA”) currently categorizes marijuana as a “drug[] with no currently accepted medical use and a high potential for abuse.” The U. S. Food and Drug Administration (“FDA”) explains on their website, almost in a regretful tone, that only four cannabis drugs have been approved by the FDA, one containing CBD and the other three containing synthetically derived THC. This categorization issue is not new, but because legislation regarding marijuana is changing rapidly federal agencies have had to play catch up with the law.  

Minnesota and Beyond 

Meanwhile, the state of Minnesota is still chugging along in terms of marijuana legalization. In July of this year, the state of Minnesota legalized the production and sale of edibles containing 5-mg of THC, which can now be purchased by adults in bags containing no more than 50-mg of THC. This sounds like good news, but many state residents are baffled at the lack of a tax provision in the new state law. The University of Maryland actually did a study on Minnesota’s potential for taxing cannabis, and determined that if the newly legalized edibles were taxed at the same rate as Michigan taxes, the state could have collected over $40 million. Given this high estimate, it is not out of the question that a tax on marijuana will be implemented in the future. 

Minnesotan employers were similarly not thrilled when the law passed as they felt ill equipped to update their drug policies. Employers “can bar workers from using, possessing, and being under the influence of THC during work hours or in the workplace,” as well as conduct “random drug testing for safety-sensitive positions” and “employees suspected of being intoxicated.” The gray area exists in the employer’s ability to hire and fire based on an applicant or employee’s use of marijuana outside of work. It is currently illegal to make hiring and firing decisions based on tobacco usage or alcohol consumption, and it is unclear if marijuana will be treated in the same manner. The added layer to marijuana testing is that a positive drug test for marijuana does not mean an employee consumed THC right before work since THC lingers in the body for so long. Thus, an employee could test positive for mairjuana at work even if they had used the drugs days ago and were no longer feeling its effects. Though the employee would have ingested the drug legally, they may not be considered for a job position or could be fired from a job they already hold. This is the type of issue that has led a number of municipalities in Minnesota to put a pause on the sale of the state legalized edibles. In contrast, California passed a law just last month protecting employees, apart from some exceptions, from being discriminated against based on their marijuana usage when not at work. What might be a little concerning is that California made recreational marijuana legal in 2016, and this law won’t go into effect until 2024, meaning there was an eight year gap in the legislation. Regardless, this may serve as the beginning of a pattern, pointing to what Minnesota may do down the line. 

In 2020 New Jersey passed a law legalizing recreational marijuana use which went into effect in April of this year. Similarly to California, part of the law protects workers from being discriminated against because of their marijuana use outside of work. However, Walmart and Sam’s Club have continued to administer drug tests to job applicants to search for traces of marijuana, a practice that has gotten them into legal trouble in New Jersey. Walmart is arguing that only the state Cannabis Regulatory Commission can enforce the new employment law, and that this case should be dismissed because it was brought by individuals. Courts in other states in which similar laws have been passed have issued decisions that oppose Walmart’s position, ruling that individual workers can sue under the law. It seems that Minnesota is not the only state that has enacted fuzzy recreational drug use laws that directly affect employers and employees. 

On the bright side of this employment confusion, many appreciate the baby step the Minnesota legislature has taken to legalize marijuana use. The state has been in dire need of updated marijuana legislation, and the hope is that continuing this legalization process will lessen the disparities between black and white arrests for marijuana possession. This change is necessary, because as of 2020 Minnesota was found to rank 8th in the United States for largest racial disparities in marijuana possession arrests. In 2021, the Minnesota Bureau of Criminal Apprehension released data showing that out of the over 6,000 marijuana related arrests made in the state, 90% were for simple possession charges, and a black person was almost five times more likely to be arrested for these types of charges than a white person. This statistic is down from almost eight times more likely back in 2010, but is still extremely present. 

In Conclusion

President Biden’s pardon is just a beginning step towards moving the US forward on marijuana legislation. Though states such as Minnesota are moving in the right direction by gradually legalizing recreational marijuana use, the laws are often unclear and lead to a multitude of logistical issues like those seen in the employment sector. Regardless, making continued progress is important to the U.S. for many reasons and is crucial for helping to lessen racial arrest disparities. Hopefully this pardon will have the effect the administration aimed for and will encourage more state legislatures to update their policies on marijuana usage.

 

 


Freedom to Moderate? Circuits Split Over First Amendment Interpretation

Annelise Couderc, MJLST Staffer

Recently, the Florida and Texas Legislatures passed substantively similar laws which restrict social media platforms’ ability to moderate posts expressing “viewpoints,” and require platforms to provide explanations for why they chose to censor certain content. These laws seemingly stem from the perception of conservative leaning users that their views are disproportionately censored, despite evidence showing otherwise. The laws are in direct conflict with the current prevalent understanding of social media’s access to First Amendment protections, which include the right to moderate content, an expression of free speech.

While the 11th Circuit declared the Florida law unconstitutional for violating social media platforms’ First Amendment rights in May, only four months later the 5th Circuit reinstated the similar Texas law without explanation, overturning the previous injunction made by the U.S. District Court for the Western District of Texas. On September 16, 2022, the 5th Circuit released its full decision explaining its reinstatement of the censorship statute, immediately raising constitutional alarm bells in the news. Following this circuit split, social media platforms must navigate a complicated legal minefield. The issue is likely to be resolved by the Supreme Court in response to Florida’s petition of the 11th Circuit’s May decision.

Social Media Platforms Are Generally Free to Moderate Content

The major social media platforms all have policies which ban certain content, or at least require a sensitivity warning to be posted before viewing certain content. Twitter restricts hate speech and imagery, gratuitous violence, sexual violence, and requires sensitive content warnings on adult content. Facebook sets Community Standards and YouTube (a Google subsidiary) sets Community Guidelines that restrict similar content.[1] Social media corporations’ access to free speech protections were well understood under settled Supreme Court precedent, and were further confirmed in the controversial 2010 Supreme Court decision Citizens United establishing the rights of corporations to make political donations as a demonstration of free speech. In sum, Courts have generally allowed social media platforms to moderate and censor sensitive content as they see fit, and platforms have embraced this through their establishment and enforcement of internal guidelines. 

Circuits Split Over First Amendment Concerns

Courts have generally rejected arguments challenging social media platforms’ ability to set and uphold their own content guidelines, upholding social media platforms’ free speech protections under the First Amendment. The 5th Circuit’s rejection of this widely accepted standard has created a circuit split which will lead to further litigation and leave social media platforms uncertain about the validity of their policies and the extent of their constitutional rights.

The 11th Circuit’s opinion in May of this year was consistent with the general understanding of social media’s place as private businesses which hold First Amendment rights. It rejected Florida’s argument that social media platforms are common carriers and stated that editorial discretion by the platforms is a protected First Amendment right.[2] The Court recognized the platforms’ freedom to abide by their own community guidelines and choose which content to prioritize as expressions of editorial judgment protected by the First Amendment.[3] This opinion was attacked directly by the 5th Circuit’s later decision, challenging the 11th Circuit’s adherence to existing First Amendment jurisprudence. 

In its September 16th opinion, the 5th Circuit refused to recognize censorship as speech, rejecting the plaintiff’s argument that content moderation was a form of editorial discretion (a recognized form of protected speech for newspapers).[4] The court also invoked common carrier doctrine—which empowers states to enforce nondiscriminatory practices for services that the public uses en masse (a classification that the 11th Circuit explicitly rejected)—, embracing it in the context of social media platforms.[5] Therefore, the court held with “no doubts” that section 7 of the Texas law—which prevents platforms from censoring “viewpoints” (with exceptions for blatantly illegal speech provoking violence, etc.) of users—was constitutional.[6] Section 2 of the contested statute, requiring social media platforms to  justify and announce their moderation choices, was similarly upheld as being a sufficiently important interest of the government, and not unduly burdensome to the businesses.[7] The law allows individuals to sue for enforcement. 

The Supreme Court’s Role and Further Implications

Florida, on September 21st, 2022, petitioned for a writ of certiorari asking the Supreme Court to review the May 2022 decision. The petition included reference to the 5th Circuit opinion, calling for the Supreme Court to weigh in on the Circuit split. Considering recent Supreme Court decisions cutting down Fourth and Fifth amendment rights, it is anticipated that First Amendment rights of online platforms may be next.

Although the Florida and Texas laws involved in these Circuit Court decisions were Republican proposed bills, a Supreme Court decision would impact blue states as well. California, for example, has proposed a bill requiring social media platforms to make public their policies on hate speech and disinformation. A decision in either direction would impact both Republican and Democratic legislatures’ ability to regulate social media platforms in any way.

Notes

[1] Studies have found that platforms like YouTube may actually push hateful content through their algorithms despite what their official policies may state.

[2] NetChoice, LLC v. AG, Fla., 34 F.4th 1196, 1222 (11th Cir. 2022).

[3] Id. at 1204.

[4] Netchoice, L.L.C. v. Paxton, No. 21-51178, 2022 U.S. App. LEXIS 26062, at *28 (5th Cir. Sep. 16, 2022).

[5] Id. at 59.

[6] Id. at 52.

[7]  Id. at 102.


A Solution Enabled by the Conflict in Ukraine, Cryptocurrency Regulation, and the Energy Crisis Could Address All Three Issues

Chase Webber, MJLST Staffer

This post focuses on two political questions reinvigorated by Vladimir Putin’s invasion of Ukraine: the energy crisis and the increasing popularity and potential for blockchain technology such as cryptocurrency (“crypto”).  The two biggest debates regarding blockchain may be its extraordinarily high use of energy and the need for regulation.  The emergency of the Ukraine invasion presents a unique opportunity for political, crypto, and energy issues to synergize – each with solutions and positive influence for the others.

This post will compare shortcomings in pursuits for environmentalism and decentralization.  Next, explain how a recent executive order is an important turning point towards developing sufficient peer-to-peer technology for effective decentralization.  Finally, suggest that a theoretical decentralized society may be more well-equipped to address the critical issues of global politics, economy, and energy use, and potentially others.

 

Relationship # 1: The Invasion and The Energy Crisis

Responding to the invasion, the U.S. and other countries have sanctioned Russia in ways that are devastating Russia’s economy, including by restricting the international sale of Russian oil.  This has dramatic implications for the interconnected global economy.  Russia is the second-largest oil exporter; cutting Russia out of the picture sends painful ripples across our global dependency on fossil fuel.

Without “beating a dead dinosaur” … the energy crisis, in a nutshell, is that (a) excessive fossil fuel consumption causes irreparable harm to the environment, and (b) our thirst for fossil fuel is unsustainable, our demand exceeds the supply and the supply’s ability to replenish, so we will eventually run out.  Both issues suggest finding ways to lower energy consumption and implement alternative, sustainable sources of energy.

Experts suggest innovation for these ends is easier than deployment of solutions.  In other words, we may be capable of fixing these problems, but, as a planet, we just don’t want it badly enough yet, notwithstanding some regulatory attempts to limit consumption or incentivize sustainability.  If the irreparable harm reaches a sufficiently catastrophic level, or if the well finally runs dry, it will require – not merely suggest – a global reorganization via energy use and consumption.

The energy void created by removing Russian supply from the global economy may sufficiently mimic the well running dry.  The well may not really be dry, but it would feel like it.  This could provide sufficient incentive to implement that global energy reset, viz., planet-wide lifestyle changes for existing without fossil fuel reliance, for which conservationists have been begging for decades.

The invasion moves the clock forward on the (hopefully) inevitable deployment of green innovation that would naturally occur as soon as we can’t use fossil fuels even if we still want to.

 

Relationship # 2: The Invasion and Crypto   

Crypto was surprisingly not useful for avoiding economic sanctions, although it was designed to resist government regulation and control (for better or for worse).  Blockchain-based crypto transactions are supposedly “peer-to-peer,” requiring no government or private intermediaries.  Other blockchain features include a permanent record of transactions and the possibility of pseudonymity.  Once assets are in crypto form, they are safer than traditional currency – users can generally transfer them to each other, even internationally, without possibility of seizure, theft, taxation, or regulation.

(The New York Times’ Latecomer’s Guide to Crypto and the “Learn” tab on Coinbase.com are great resources for quickly building a basic understanding of this increasingly pervasive technology.)

However, crypto is weak where the blockchain realm meets the physical realm.  While the blockchain itself is safe and secure from theft, a user’s “key” may be lost or stolen from her possession.  Peer-to-peer transactions themselves lack intermediaries, but hosts are required for users to access and use blockchain technology.  Crypto itself is not taxed or regulated, but exchanging digital assets – e.g., buying bitcoin with US dollars – are taxed as a property acquisition and regulated by the Security Exchange Commission (SEC).  Smart contract agreements flounder where real-world verification, adjudication, or common-sense is needed.

This is bad news for sanctioned Russian oligarchs because they cannot get assets “into” or “out of” crypto without consequence.  It is better news for Ukraine, where the borderless-ness and “trust” of crypto transaction eases international transmittal of relief assets and ensures legitimate receipt.

The prospect of crypto being used to circumvent U.S. sanctions brought crypto into the federal spotlight as a matter of national security.  President Biden’s Executive Order (EO) 14067 of March 9, 2022 offers an important turning point for blockchain: when the US government began to direct innovation and government control.  Previously, discussions of whether recognition and control of crypto would threaten innovation, or a failure to do so would weaken government influence, had become a stalemate in regulatory discussion. The EO seems to have taken advantage of the Ukraine invasion to side-step the stagnant congressional debates.

Many had recognized crypto’s potential, but most seemed to wait out the unregulated and mystical prospect of decentralized finance until it became less risky.  Crypto is the modern equivalent of private-issued currencies, which were common during the Free Banking Era, before national banks were established at the end of the Civil War.  They were notoriously unreliable.  Only the SEC had been giving crypto plenty of attention, until (and especially) more recently, when the general public noticed how profitable bitcoin became despite its volatility.

EO 14067’s policy reasoning includes crypto user protection, stability of the financial system, national security (e.g., Russia’s potential for skirting sanctions), preventing crime enablement (viz., modern equivalents to The Silk Road dark web), global competition, and, generally, federal recognition and support for blockchain innovation.  The president asked for research of blockchain technology from departments of Treasury, Defense, Commerce, Labor, Energy, Homeland Security, the Consumer Financial Protection Bureau (CFPB), Federal Trade Commission (FTC), SEC, Commodity Futures Trading Commission (CFTC), Environmental Protection Agency (EPA), and a handful of other federal agencies.

While promoting security and a general understanding of blockchain’s potential uses and feasibility, the order also proposes Central Bank Digital Currencies (CBDC).  CBDCs are FedCoins – a stablecoin issued by the government instead of by private entities.  Stablecoins (e.g., Tether) are a type of crypto whose value is backed by the US Dollar, whereas privately issued crypto (e.g., Bitcoin, Ether) are more volatile because their value is backed by practically nothing.  So, unlike Tether, a privately issued stablecoin, CBDCs would be crypto issued and controlled by the U.S. Treasury.

Imagine CBDCs as a dollar bill made of blockchain technology instead of paper.  A future “cash transaction” could feel more like using Venmo, but without the intermediary host, Venmo.

 

Relationship # 3: Crypto and Energy

Without getting into too many more details, blockchain technology, on which crypto is based, requires an enormous amount of energy-consuming computing power.

Blockchain is a decentralized “distributed ledger technology.” The permanent recordings of transactions are stored and verifiable at every “node” – the computer in front of you could be a node – instead of in a centralized database.  In contrast, the post you are now reading is not decentralized; it is “located” in a UMN database somewhere, not in your computer’s hard drive.  Even a shared Google Doc is in a Google database, not in each of the contributor’s computers.  In a distributed system, if one node changes its version of the distributed ledger, some of the other nodes verify the change.  If the change represents a valid transaction, the change is applied to all versions at each node, if not, the change is rejected, and the ledger remains intact.

These repeated verifications give blockchain its core features, but also require a significant amount of energy.

For most of the history of computers, computing innovation has focused primarily on function, especially increased speed.  Computer processing power eventually became sufficiently fast that, in the last twenty-ish years, computing innovation began to focus on achieving the same speed using less energy and/or with more affordability.  Automotive innovation experienced a similar shift on a different timeline.

Blockchain will likely undergo the same evolution.  First, innovators will focus on function and standardization.  Despite the popularity, this technology still lacks in these areas.  Crypto assets have sometimes disappeared into thin air due to faulty coding or have been siphoned off by anonymous users who found loopholes in the software.  Others, who became interested in crypto during November 2021, after hearing that Ether had increased in value by 989% that year and the crypto market was then worth over $3 trillion, may have been surprised when the value nearly halved by February.

Second, and it if it is a profitable investment – or incentivized by future regulations resulting from EO14067 – innovators will focus on reducing the processing power required for maintaining a distributed ledger.

 

Decentralization, and Other Fanciful Policies

Decentralization and green tech share the same fundamental problem.  The ideas are compelling and revolutionary.  However, their underlying philosophy does not yet match our underlying policy.  In some ways, they are still too revolutionary because, in this author’s opinion, they will require either a complete change in infrastructure or significantly more creativity to be effective.  Neither of these requirements are possible without sufficient policy incentive.  Without the incentive, the ideas are innovative, but not yet truly disruptive.

Using Coinbase on an iPhone to execute a crypto transaction is to “decentralization” what driving a Tesla running on coal-sourced electricity is to “environmentalism.”  They are merely trendy and well-intentioned.  Tesla solves one problem – automotive transportation without gasoline – while creating another – a corresponding demand for electricity – because it relies on existing infrastructure.  Similarly, crypto cannot survive without centralization.  Nor should it, according to the SEC, who has been fighting to regulate privately issued crypto for years.

At first glance, EO 14067 seems to be the nail in the coffin for decentralization.  Proponents designed crypto after the 2008 housing market crash specifically hoping to avoid federal involvement in transactions.  Purists, especially during The Digital Revolution in the 90s, hoped peer-to-peer technology like blockchain (although it did not exist at that time) would eventually replace government institutions entirely – summarized in the term, “code is law.”  This has marked the tension between crypto innovators and regulators, each finding the other uncooperative with its goals.

However, some, such as Kevin Werbach, a prominent blockchain scholar, suggest that peer-to-peer technology and traditional legal institutions need not be mutually exclusive.  Each offers unique elements of “trust,” and each has its weaknesses.  Naturally, the cooperation of novel technologies and existing legal and financial structures can mean mutual benefit.  The SEC seems to share a similarly cooperative perspective, but distinguished, importantly, by the expectation that crypto will succumb to the existing financial infrastructure.  Werbach praises EO 14067, Biden’s request that the “alphabet soup” of federal agencies investigate, regulate, and implement blockchain, as the awaited opportunity for government and innovation to join forces.

The EPA is one of the agencies engaged by the EO.  Pushing for more energy efficient methods of implementing blockchain technology will be as essential as the other stated policies of national security, global competition, and user friendliness.  If the well runs dry, as discussed above, blockchain use will stall, as long as blockchain requires huge amounts of energy.  Alternatively, if energy efficiency can be attained preemptively, the result of ongoing blockchain innovation could play a unique role in addressing climate change and other political issues, viz., decentralization.

In her book, Smart Citizens, Smarter State: The Technologies of Expertise and the Future of Governing, Beth Simone Noveck suggests an innovative philosophy for future democracies could use peer-to-peer technology to gather wide-spread public expertise for addressing complex issues.  We have outgrown the use of “government bureaucracies that are supposed to solve critical problems on their own”; by analogy, we are only using part of our available brainpower.  More recently, Decentralization: Technology’s Impact on Organizational and Societal Structure, by local scholars Wulf Kaal and Craig Calcaterra, further suggests ways of deploying decentralization concepts.

Decentralized autonomous organizations (“DAOs”) are created with use of smart contracts, a blockchain-based technology, to implement more effectively democratic means of consensus and information sharing.  However, DAOs are still precarious.  Many of these have failed because of exploitation, hacks, fraud, sporadic participation, and, most importantly, lack of central leadership.  Remember, central leadership is exactly what DAOs and other decentralized proposals seek to avoid.  Ironically, in existing DAOs, without regulatory leadership, small, centralized groups of insiders tend to hold all the cards.

Some claim that federal regulation of DAOs could provide transparency and disclosure standards, authentication and background checks, and other means of structural support.  The SEC blocked American CryptoFed, the first “legally sanctioned” DAO, in the state of Wyoming.  Following the recent EO, the SEC’s position may shift.

 

Mutual Opportunity

To summarize:  The invasion of Ukraine may provide the necessary incentive for actuating decentralized or environmentalist ideologies.  EO 14067 initiates federal regulatory structure for crypto and researching blockchain implementation in the U.S.  The result could facilitate eventual decentralized and energy-conscious systems which, in turn, could facilitate resolutions to grave impending climate change troubles.  Furthermore, a new tool for gathering public consensus and expertise could shed new light on other political issues, foreign and domestic.

This sounds suspiciously like, “idea/product X will end climate change, all political disagreements, (solve world hunger?) and create global utopia,” and we all know better than to trust such assertions.

It does sound like it, but Noveck and Kaal & Calcaterra both say no, decentralization will not solve all our problems, nor does it seek to.  Instead, decentralization offers to make us, as a coordinated society, significantly more efficient problem solvers.  A decentralized organizational structure hopes to allow humans to react and adapt to situations more naturally, the way other living organisms adapt to changing environments.  We will always have problems.  Centralization, proponents argue, is no longer the best means of obtaining solutions.

In other words, one hopes that addressing critical issues in the future – like potential military conflict, economic concerns, and global warming – will not be exasperated or limited by the very structures with which we seek to devise and implement a resolution.


Save the Children . . . From Algorithms?

Sarah Nelson, MJLST Staffer

Last week, a bill advanced out of the Minnesota House Commerce Finance and Policy Committee that would ban social media platforms from utilizing algorithms to suggest content to those under the age of 18. Under the bill, known as HF 3724, social media platforms with more than one million account holders that operate in Minnesota, like Instagram, Facebook, and TikTok, would no longer be able to use their algorithms to recommend user-generated content to minors.

The sponsor of the bill, Representative Kristin Robbins, a Republican from Maple Grove, said that she was motivated to sponsor HF 3724 after reading two articles from the Wall Street Journal. In the first, the Wall Street Journal created dozens of automated accounts on the app TikTok, which it registered as being between the ages of 13 and 15. The outlet then detailed how the TikTok algorithm, used to create a user’s For You feed, would inundate teenage users with sex- and drug-related content if they engaged with that content. Similarly, in the second article, the Wall Street Journal found that TikTok would repeatedly present teenagers with extreme weight loss and pro-eating disorder videos if they continued to interact with that content.

In response to the second article, TikTok said it would alter its For You algorithm “to avoid showing users too much of the same content.” It is also important to note that per TikTok’s terms of service, to use the platform, users must be over 13 and must have parental consent if they are under 18. TikTok also already prohibits “sexually explicit material” and works to remove pro-eating disorder content from the app while providing a link to the National Eating Disorders Association helpline.

As to enforcement, HF 3724 says social media platforms are liable to account holders if the account holder “received user-created content through a social media algorithm while the individual account holder was under the age of 18” and the social media platform “knew or had reason to know that the individual account holder was under the age of 18.” Social media platforms would then be “liable for damages and a civil penalty of $1,000 for each violation.” However, the bill provides an exception for content “that is created by a federal, state, or local government or by a public or private school, college, or university.”

According to an article written on the bill by the legislature, Robbins is hopeful that HF 3724 “could be a model for the rest of the country.”

 

Opposition from Tech

As TechDirt points out, algorithms are useful; they help separate relevant content from irrelevant content, which optimizes use of the platform and stops users from being overwhelmed. The bill would essentially stop young users from reaping the benefits of smarter technology.

A similar argument was raised by NetChoice, which expressed concerns that HF 3724 “removes the access to beneficial technologies from young people.” According to NetChoice, the definition of “social media” used in the bill is unacceptably broad and would rope in sites that teenagers use “for research and education.” For example, NetChoice cites to teenagers no longer being able to get book recommendations from the algorithm on Goodreads or additional article recommendations on a research topic from an online newspaper.

NetChoice also argues that HF 3724 needlessly involves the state in a matter that should be left to the discretion of parents. NetChoice explains that parents, likely knowing their child best, can decide on an individual basis whether they want their children on a particular social media platform.

Opponents of the bill also emphasize that complying with HF 3724 would prove difficult for social media companies, who would essentially have to have separate platforms with no algorithmic functions for those under 18. Additionally, in order to comply with the bill, social media platforms would have to collect more personal data from users, including age and location. Finally, opponents have also noted that some platforms actually use algorithms to present appropriatecontent to minors. Similarly, TikTok has begun utilizing its algorithms to remove videos that violate platform rules.

 

What About the First Amendment?

In its letter to the Minnesota House Commerce Committee, NetChoice said that HF 3724 would be found to violate the First Amendment. NetChoice argued that “multiple court cases have held that the distribution of speech, including by algorithms such as those used by search engines, are protected by the First Amendment” and that HF 3724 would be struck down if passed because it “result[s] in the government restraining the distribution of speech by platforms and Minnesotans access to information.”

NetChoice also cited to Ashcroft v. ACLU, a case in which “the Supreme Court struck down a federal law that attempted to prevent the posting of content harmful to teenagers on the web due to [the fact it was so broad it limited adult access] as well as the harm and chilling effect that the associated fines could have on legal protected speech.”

As Ars Technica notes, federal courts blocked laws pertaining to social media in both Texas and Florida last year. Both laws were challenged for violating the First Amendment.

 

Moving Forward

HF 3724 advanced unanimously out of the House Judiciary Finance and Civil Law Committee on March 22. The committee made some changes to the bill, specifying that the legislation would not impact algorithms associated with email and internet search providers. Additionally, the committee addressed a criticism by the bill’s opponents and exempted algorithms used to filter out age-inappropriate content. There is also a companion bill to HF 3724, SF3922, being considered in the Senate.

It will be interesting to see if legislators are dissuaded from voting for HF 3724 given its uncertain constitutionality and potential impact on those under the age of 18, who will no longer be able to use the optimized and personalized versions of social media platforms. However, so far, to legislators, technology companies have not put their best foot forward, as they have sent lobbyists in their stead to advocate against the bill.


Hydrogen – The Fuel of the Future?

Max Meyer, MJLST Staffer

Hydrogen is viewed by many as being a key part of reducing global greenhouse gas emissions. Recently, a bipartisan group of lawmakers expressed interest in hydrogen and want to support its adoption in the United States. When used as a fuel source, hydrogen produces only water and heat. It could potentially be used to power cars, trucks, and airplanes and generate electricity. Hydrogen is used on a fairly minimal scale today, but entities ranging from industry to government are increasing investment in the technology. Currently, hydrogen is regulated by a variety of federal agencies, but no comprehensive regulatory scheme exists.

 

Hydrogen Production 

Hydrogen is one of the most abundant elements on earth, but it only exists in compound form with other elements. Hydrogen has the highest fuel content of any fuel by weight.

Hydrogen can be separated from compounds in a few different ways. It can be produced from steam-methane reforming which accounts for 95% of hydrogen production in the U.S. In this process, “natural gas (which is mostly methane) reacts with high pressure, high temperature steam in the presence of a catalyst to produce a mixture of mostly hydrogen and carbon monoxide.” The product stream is then processed further to produce a stream of mostly hydrogen. Water can be added to this mixture to convert the carbon monoxide into carbon dioxide. If the carbon dioxide is subsequently capture and stored underground, the hydrogen produced is referred to as blue hydrogen. If the carbon dioxide is not captured, the hydrogen is called grey hydrogen.

Hydrogen can also be produced from water by electrolysis which splits water molecules into pure hydrogen and oxygen using electricity. When renewable energy is used for electrolysis the resulting hydrogen is often referred to as green hydrogen.

 

Why Is It Important?

Using fuel cells, hydrogen can produce electricity. A fuel cell contains two electrodes, one negative and one positive, with an electrolyte in the middle. Hydrogen is fed into the negative electrode and air is fed into the positive end. At the negative end, a catalyst separates the hydrogen molecules into protons and electrons. To produce electricity, the electrons go through an external circuit before entering the positive electrode. Then, the protons, electrons, oxygen unite to produce water and heat. Fuel cells can be used in a number of applications ranging passenger and commercial vehicles to powering buildings.

 

Current Regulatory Framework

Hydrogen is regulated by several federal agencies. The Pipeline and Hazardous Materials Safety Administration (PHMSA) regulates hydrogen pipelines. PHMSA’s mission is to “protect people and the environment by advancing the safe transportation of energy and other hazardous materials[.]” Thus, PHMSA’s regulation of hydrogen pipelines is focused on safety. The Occupational Safety and Health Administration (OSHA) regulates hydrogen in workplaces OSHA’s regulation of hydrogen specifically covers the installation of hydrogen systems. The Environmental Protection Agency (EPA) also regulates hydrogen in several ways. Hydrogen is regulated under the EPA’s Mandator Greenhouse Gas Reporting Program, Effluent Standards under the Clean Water Act, and Chemical Accident Prevention program. However, the EPA’s regulation of hydrogen is primarily a result of hydrogen’s relationship to fossil fuels. The regulations are concerned with the production of hydrogen from fossil fuels such as the methane steam reform process outlined above.

The Department of Energy (DOE) has invested in research and development concerning hydrogen. In 2020, the DOE released its Hydrogen Program Plan. The DOE’s program is intended to “research, develop and validate transformational hydrogen and related technologies… and to address institutional and market barriers, to ultimately enable adoption across multiple applications and sectors.”

In 2021, Congress passed an infrastructure bill with $9.5 billion of funding for clean hydrogen initiatives. $8 billion of that funding is directed towards the creation of Regional Clean Hydrogen Hubs across the country to increase the use of hydrogen in the industrial sector. $1 billion is for clean hydrogen electrolysis research to lower costs from producing hydrogen using renewable energy. Finally, $500 million is for Clean Hydrogen Manufacturing and Recycling to “support equipment manufacturing and strong domestic supply chains.”

 

Regulation in the Future

The federal government currently does not regulate the construction of hydrogen pipelines. Presently, the Federal Energy Regulatory Commission (FERC) under the Natural Gas Act “regulates the siting, construction, and operation of interstate natural gas pipelines.” If Congress were to give FERC this same power for hydrogen pipelines it would allow for national planning of the infrastructure and lead to a comprehensive pipeline network. Recently, members of Congress have considered the regulatory framework covering hydrogen pipelines and if additional authority over these pipelines should be given to FERC or other federal agencies. However, these discussions are still in the preliminary stages.

Hydrogen has the potential to play a large role in the United States’ effort to reduce greenhouse gas emissions. It can be used in a variety of industries including the transportation and industrial sectors. Congress has recognized hydrogen’s importance and must continue to invest in lowering the costs of hydrogen production and building hydrogen infrastructure.


The Mysterious Disappearance of Deference: What Is the Supreme Court’s Current Relationship to Federal Agencies?

Carly Michaud, MJLST Staffer

The Supreme Court has had no shortage of administrative law cases in the (possibly) final sessions of one of the Court’s administrative law scholars, Justice Stephen Breyer. Yet, Breyer has found himself and his ideological compatriots in the opposition on the topic in which he situates his expertise. In the recent case regarding OSHA’s ability to require COVID-19 vaccines, Breyer’s dissent repeated discusses the proper deference an agency’s determination should be given by the Supreme Court.

Notably absent from the case is any mention of the previous key to the relationship between the courts and federal agencies: Chevron deference. In fact, Chevron U.S.A., Inc. v. National Resources Defense Council, was, (as of a 2014 analysis in the Yale Journal on Regulation) the “Most Cited Supreme Court Administrative Law decision”. While previously considered a niche area, administrative law is now so ubiquitous in practice that as of July 2021, 55 law schools require students take a course in administrative law or one of its mainstays: legislation or statutory interpretation.

In spite of this, Chevron appears nowhere in the discussion of OSHA’s vaccine mandate, nor in the court’s earlier revocation of the CDC’s eviction moratorium. This absence suggests that perhaps this Court has become a body of health experts, relying on their own understanding of COVID-19 to determine whether these agency-created regulations are effective in their mission. Both cases center on whether an agency action to prevent the spread of COVID-19 is within the purview of their empowering statute, and, despite the broad statutory authorities of these agencies to protect the health of Americans, both actions were deemed beyond that authority.

But back to Chevron, has it been abandoned as a standard? Not yet, although there was some discussion of this proposition during the oral argument of American Hospital Association v. Becerra last November. The Court has not released an opinion yet on this case, however the Court of Appeals had previously upheld HHS’s ability to set reembursement rates, per its statutory authority.

In a final thrust of irony, the death knell for Chevron deference may come from a case challenging the very statute and the very agency whose decision-making was at issue in Chevron: the EPA and the Clean Air Act. This is particularly ironic as the EPA administrator whose decision-making was being challenged in Chevron was Anne Gorsuch, the mother of Supreme Court justice and noted antagonist of agency authority: Neil Gorsuch. Yes, in a tale mirroring Hamlet, Neil Gorsuch seems determined to destroy the administrative state that had entangled his mother in various administrative scandals. The latest edition of this showdown between the Gorsuchs and EPA is scheduled for Monday February 28, which will see the Supreme Court hearing arguments in West Virginia v. EPA and its consolidated cases.

This behavior by the Court belies a grave concern both about the continued disempowerment of federal agencies—which have been empowered directly by Congress—at the hands of the unelected judiciary. Further, the most cynical of us may see this as a direct assault on the authority of agencies that some justices may politically disagree with, further disregarding the knowledge of learned experts to push their own political agendas.


You Gotta Fight for Your Right to Repair

Christopher Cerny, MJLST Staffer

Last spring, as the first wave of the coronavirus pandemic hit critical heights, many states faced a daunting reality. The demand for ventilators, an “external set of lungs” designed to breathe for a patient too weak or compromised to breathe on their own, skyrocketed. Hospitals across the United States and countries around the globe clamored for more of the life saving devices. In March and April of 2020, the increasing need for this equipment forced doctors in Washington State, New York, Italy, and around the world to make heartbreaking decisions to prioritize the scarce supply. With this emergency equipment operating at maximum capacity, any downtime meant another potential life lost. But biomeds, hospital technicians who maintain these crucial medical devices, were frequently unable to troubleshoot or repair out-of-service ventilators to return them to the frontlines. This failure to fix the much-needed equipment was not due to lack of time or training. Instead, it was because many manufacturers restrict access to repair materials, such as manuals, parts, or diagnostic equipment. According to one survey released in February 2021, 76% of biomeds said that manufacturers denied them access to parts or service manuals in the previous three months and 80% said they have equipment that cannot be serviced due to manufacturers’ restrictions to service keys, parts, or materials.

While the prohibition of repairs of life support equipment highlights the extreme danger this restriction creates, the situation is not unique to hospitals and emergency equipment. As technology becomes increasingly complex and proprietary, all manner of tech manufacturers are erecting more and more barriers that prevent owners and independent repair shops from working on their products. Tesla, for example, is adamant about restricting repairs to its vehicles. The electric vehicle auto maker will not provide parts or authorize repairs if performed at an uncertified, independent repair shop or end user. Tesla has gone so far as to block cars repaired outside of its network from using its Superchargers. Apple historically also prevented end users from performing their own repairs, utilizing specialized tools and restricting access to parts. John Deere requires farmers to comply with a software licensing agreement that is in appearance designed to protect the company’s proprietary software, but in practice prevents farmers from clearing error codes to start their farm equipment without an authorized technician.

In response to these obstructions to repair, the Right to Repair movement solidified around the simple proposition that end users and independent repair shops should be provided the same access to manuals and parts that many tech companies reserve solely to themselves or their subsidiaries. This proposition is catching on and the legislatures in twenty-five states are currently considering thirty-nine bills involving the right to repair. However, of the thirty-nine bills, only three address medical technology with the bulk of the proposals devoted to general consumer products—think appliances, iPads, and smart devices—and farm equipment.

Massachusetts is an early adopter of right to repair laws. Its legislature passed a law in 2012 specific to motor vehicles that, inter alia, standardized diagnostic and service information, mandated its accessibility by owners and independent or third-party repair shops, and established any violation of the provisions of the act as an unfair method of competition and an unfair trade practice. This past November, Massachusetts voters approved a ballot measure that expanded the scope of the 2012 right to repair law and closed a loophole that could circumvent the requirements imposed in the earlier statute. Automakers lobbied in force to oppose the measure, spending in excess of $25 million in advertising and other efforts. Taking into account the money spent by both sides of the ballot measure, the right to repair initiative was the most expensive measure campaign in Massachusetts history. The European Union is also taking steps to broaden access to repair materials and information. The European Parliament passed a resolution aimed at facilitating a circular economy. Acknowledging the finite nature of many of the rare elements used in modern technology, the European Union is aiming to make technology last longer and to create a second-hand market for older models. The resolution expanding repair access is a part of that effort by ensuring the ease of repair to prolong the life of the technology and delay obsolescence.

Some manufacturers are making concessions in the face of the Right to Repair Movement. Apple, notoriously one of the most restrictive manufacturers, did an about face in 2019 and expanded access to “parts, tools, training, repair manuals and diagnostics” for independent repair businesses working on out of warranty iPhones. Tesla opened its repair platform to independent repair shops in the European Union after the EU Commission received complaints, but the access can be prohibitively expensive at €125 per hour for the use of diagnostics and programming software. However, these minimal efforts are stop-gap measures designed to slow the tide of legislation and resolutions aimed at broadening access to the materials needed to perform repairs to break the monopolistic hold manufacturers are trying to exert over routine fixes.

The Right to Repair movement is clearly gaining ground as the implications of this anticompetitive status quo in the repair and second-hand market was brought into stark relief by the strains imposed by the COVID-19 pandemic, which strained not only hospitals but agriculture, infrastructure, and day-to-day life. The impact of these restrictions on independent repair shops, farmers, consumers, patients, and do-it-yourselfers more than ever became an obvious impediment to health, safety, and a less extractive economy. And as shown in Massachusetts, voters are responding by expanding the right to repair, even in the face of expensive lobbying and advertising campaigns. Legislators should continue to bring additional bills, especially addressing the restrictions on repairs of emergency medical equipment and should enact the existing proposals in the twenty-five states currently considering them.