Articles by mjlst

FDA Warning Letters: Knocking on the Doors of Courthouses

April 23, 2013
Uncategorized

by Katelyn DeRuyter, UMN Law Student, MJLST Staff

The FDA is responsible for safeguarding public health by “assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.” The FDA inspects products and manufacturing facilities in order to ensure these important goals. If the inspection finds that a company has fallen short of the applicable standards, the FDA often will issue a Warning Letter. An FDA warning letter is written correspondencee “that notifies regulated industry about violations that FDA has documented during its inspections or investigations.” The FDA views warning letters as giving the recipient an opportunity to take voluntary and prompt corrective action before the FDA initiates official enforcement action. Despite the fact that the FDA Warning Letter is considered a mechanism for inducing “voluntary” compliance, in recent student note published in Issue 12.2 of the Minnesota Journal of Law, Science & Technology, entitled “FDA Goes Loko,” Rebecca Boxhorn argues that warning letters do not induce truly voluntary compliance because recipients that do not wish to voluntarily comply have limited options. Under the current state of the law, FDA Warning Letters are not subject to judicial review. This lack of judicial review is problematic because warning letters subject recipients to real consequences. Boxhorn proposes that FDA Warning Letters should be subject to judicial review.

This positions runs contrary to current case-law but is supported by many industry participants. The crux of the Boxhorn’s argument is that given the consequence of receiving a warning letter, “judicial review of warning letters must be allowed to protect regulated parties from agency coercion and potential misapplications of the law.”

A recent Supreme Court decision in Sacketts v. EPA has sparked speculation over whether courts will begin to re-evaluate their previous view of FDA Warning Letters as not fit for judicial review. The Court in Sackett analyzed whether an EPA Compliance Order constituted final agency action that was subject to APA judicial review. The Sacketts brought suit in U.S. District of Idaho claiming the EPA’s compliance order was arbitrary and capricious and deprived them of life, liberty, or property, without due process of law, in violation of the Fifth Amendment. The district court dismissed the claims based on the lack of subject matter jurisdiction and the Ninth Circuit affirmed. The Court granted certiorari, reversed the Ninth Circuit’s decision, and held that the contested compliance order constituted “final agency action for which there [was] no adequate remedy other than APA review, and that the Clean Water Act does not preclude that review.”

The Court analyzed whether the compliance order in question constitutes final agency action and concluded that it “has all of the hallmarks of APA finality that our opinions establish.” The opinion walked through three factors that support the finding that the compliance order is final agency action: (1) the fact that “[t]hrough the order, the EPA ‘determined’ ‘rights or obligations;'” (2) the fact that “‘legal consequences . . . flow[ed]’ from issuance of the order;” and (3) that the agency action “mark[ed] the ‘consummation’ ‘of the agency’s decision making process.'” Whether applying Sackett would lead a court to conclude that an FDA warning letter is final agency action depends on the extent to which the warning letter in question is similar, or dissimilar, in language and ramifications, to the compliance order addressed in Sackett–at least in regards to the “hallmarks of finality.” A key component of the Sackett Court’s analytical approach is the fact that the Court looked beyond the EPA’s stated intent of compliance orders, and evaluated the actual effect of the compliance order on the Sacketts. If courts adopt this approach and look at the consequences of receiving a warning letter, recipients might finally gain access to judicial review.

Is Food the New Tobacco: Science, Advertising, and the War against Obesity?

April 18, 2013
FDA, Food and Agriculture, Public Health

by George David Kidd, UMN Law Student, MJLST Staff

Globally, obesity and its underlying ailments have overtaken tobacco as the top preventable cause of death. But, while eating right and exercising might go a long way towards solving the problem, the solution might not be that simple. What drives consumer buying behavior, through more modern forms of how we interact with the world, might substantiate food science and advertising as powerful mechanisms to attack the obesity epidemic.

In Food Advertising and Childhood Obesity: A Call for Action for Proactive Solutions, published in Issue 12.2 of the Minnesota Journal of Law, Science & Technology, life and health sciences author Roseann Termini and others add advertising to the already-large list of “other” factors affecting childhood obesity rates. Indeed, children are not as informed as adults about health and may be more likely influenced by certain channels of advertising, such as television. To address this concern, one of her proposed solutions is to ban, regulate, or even shift tax structure in order to control advertising that specifically targets children. While this might be an effective mechanism to reduce demand, it may only be a partial solution. For one, because children are not, generally, the direct purchaser of food, but rather depend upon parents, to what extent does advertising actually affect the buying decisions of parents?

An article recently mentioned in The New York Times, The Extraordinary Science of Addictive Junk Food, might help answer this question. Mr. Moss similarly explores the “obesity epidemic,” but from a corporate standpoint, positing that consumers are primarily driven to buy what “tastes good.” While Mr. Moss’s article also agrees that advertising is part of the problem, he paints a more complete picture of what might be the underlying cause of parental acquiescence in a child’s poor dietary choices. The perfect combination of salt, fat, and sugar might be, in part, to blame as addicting foods that influence buying behavior. In this way, food is likened to tobacco, except, unfortunately, while people can choose whether to begin smoking, all people must eat.
While the analogy between food and tobacco may be imperfect, the point is there. If the majority of the food available to the everyday consumer is manufactured as addicting, to what degree is there a choice to eat healthy? If, in order to survive in the marketplace, a corporation has to manufacture “addicting” foods to compete, how can we make these addicting foods into disease-preventing rather than disease-aiding choices? Food science and advertising may contain the answer.

Cybersecurity: Serious threat or “technopanic”?

April 17, 2013
Cyber Security, Internet, Law Enforecement

by Bryan Dooley, UMN Law Student, MJLST Staff

While most would likely agree that threats to cybersecurity pose sufficient risk to warrant some level of new regulation, opinions vary widely on the scope and nature of an appropriate response. The Cyber Intelligence Sharing and Protection Act, one of several proposed legislative measures intended to address the problem, has drawn widespread criticism. Concerns voiced by opponents have centered on privacy and the potential for misuse of shared information. Some fear the legislation creates the potential for additional harm by allowing or encouraging private parties to launch counterattacks against perceived security threats, with no guarantee they will always hit their intended targets.

In Technopanics, Threat Inflation, and the Danger of an Information Technology Precautionary Principle</strong>, published in Issue 14.1 of the Minnesota Journal of Law, Science & Technology, Adam Thierer discusses the danger of misguided regulation in response to new and potentially misunderstood technological developments. The discussion centers on what Thierer terms “technopanics”–hasty and often irrational pushes to address a problem in the face of uncertainty and misinformation, sometimes intentionally disseminated by parties who hope to benefit financially or advance a social agenda.

In the context of cyber security, Thierer argues that advocates of an aggressive regulatory response have exaggerated the potential for harm by using language such as “digital Pearl Harbor” and “cyber 9/11.” He argues technopanics have influenced public discourse about a number of other issues, including online pornography, privacy concerns associated with targeted advertising, and the effects of violent video games on young people. While these panics often pass with little or no real lasting effect, Thierer expresses concern that an underlying suspicion toward new technological developments could mature into a precautionary principal for information technology. This would entail a rush to regulate in response to any new development with a perceived potential for harm, which Thierer argues would slow social development and prevent or delay introduction of beneficial technologies.

It’s an interesting discussion. Whether or not cyber attacks pose the potential for widespread death and destruction, there is significant potential for economic damage and disruption, as well as theft or misuse of private or sensitive information. As in any case of regulation in the face of uncertainty, there is also clear potential that an overly hasty or inadequately informed response will go too far or carry unintended consequences.

Kirtsaeng’s Parade of [Less]-Horribles

April 17, 2013
Uncategorized

by Caroline Marsili, UMN Law Student, MJLST Staff

In a 6-3 decision that came down March 25, the Supreme Court held that copyright’s first sale doctrine, which allows the lawful purchaser of a copyrighted product to resell the product without interference from the copyright holder, applies to copyrighted works lawfully made abroad. Kirtsaeng v. John Wiley & Sons marks the resolution of a decades-long uncertainty over the potential international reach of the first sale doctrine. This moment of clarity, however, is sure to be followed by challenges, given the newly-sanctioned threat to some domestic industries.

From a legal standpoint, the case was rightly decided. Briefly, plaintiff publishing company John Wiley & Sons sought relief from Cornell student-turned-professor Supap Kirtsaeng, who paid his way through university by reselling Wiley’s English-language textbooks manufactured abroad. Kirtsaeng’s family bought the books in Thailand and mailed them to Kirtsaeng, who resold them on eBay for a profit. In finding for Kirtsaeng, the majority attempted to reconcile a tension between the language of § 602(a)(1) of the Copyright Act, which gives copyright owners redress for unauthorized importation of their copyrighted work into the U.S., and the first sale doctrine (§ 109(a)), which gives owners of particular copies “lawfully made under this title” the right to sell the copy without the owner’s permission.

As author Benjamin Hamborg astutely foreshadowed in John Wiley & Sons, Inc. v. Kirtsaeng: The Uncertain Future of the First Sale Doctrine (Minnesota Journal of Law, Science & Technology, Vol. 13.2), the Court reasoned that the text of 109(a) contains no geographical limitations, and that Congressional intent and historical context further require an interpretation of first sale unbound by territory. Justice Breyer’s majority opinion further acknowledges the far-reaching policy implications a geographical limitation would have on “[a]ssociations of libraries, used-book dealers, technology companies, consumer-goods retailers, and museums.” In her dissent, Justice Ginsburg criticized the Court’s “parade of horribles” as unfounded, and observed the opinion would frustrate Congress’s intent to permit international market segmentation by copyright owners. Ultimately, in reversing the Second Circuit and criticizing a “purely geographical interpretation” of 109(a), the decision represents a victory for institutions such as libraries and for consumers.

But while the Court dodged the parade of horribles that Justice Breyer adamantly sought to avoid in oral arguments, the international reach of first sale sounds alarms for U.S. companies that will be threatened by unrestricted gray market competition. A recent NYTimes article aptly identifies some of the other horribles waiting in the wings of an international exhaustion doctrine, including the undercutting of domestic software prices, de-segmentation of international publishing markets, threats to a burgeoning secondhand digital marketplace (though first sale may not apply here), and another nail in the coffin of print publications. Further, Kirtsaeng has the potential to set an example for amateur sellers to profit from gray market goods.

So what’s to be done? In “Next Moves For IP Law After SCOTUS First-Sale Ruling,” Lisa Shuchman suggests a number of options for copyright owners to numb the sting of Kirstaeng. Options include pursuing other legal remedies like contract and more expansive trademark protection, digitizing their protected content, raising domestic prices (to off-set losses from sale of imported copies), and pursuing statutory reform. Others suggest first sale is on its way to mootness in an increasingly digital economy. Raustiala and Sprigman’s solution? “Stop selling copies. Start licensing digital files.” Still others argue statutory reform is unavoidable. Andrew Albanese suggests the Court did what was best with a convoluted statute, but that Congress will need to address the outdated Copyright Act.

Though Kirstaeng undoubtedly provides much-needed clarification on the status of first sale, the story isn’t over for domestic copyright owners seeking to prevent unwanted, but now legal, importation of their works. Grab a seat on the curb . . .

Supreme Court to the Rescue: The First Sale Doctrine Survives

April 9, 2013
Intellectual Property

by Benjamin Hamborg, UMN Law Student, MJLST Articles Editor

As predicted inJohn Wiley & Sons, Inc. v. Kirtsaeng: The Uncertain Future of the First-Sale Doctrine, the Supreme Court last month held, by a 6-3 margin, that the first sale doctrine does apply to works lawfully made outside of the United States. The first sale doctrine, which allows the lawful owner of a copyrighted work to dispose of that copy as he or she sees fit, was in danger of disappearing as applied to works manufactured overseas after the Second Circuit decided in August of 2011 that the doctrine only applied to works made in America.

Hailed by many as a victory for American consumers, See Gary Shapiro, Supreme Court Gives American Consumers Victory Over Copyright Owners in Kirtsaeng vs. John Wiley & Sons, FORBES (March 20, 2013, 9:16 AM), the decision also represents an important victory for American manufacturing. A decision to the contrary by the Supreme Court would have given companies in the United States, particularly publishing companies, an incentive to move manufacturing plants oversees in order to gain unlimited control over the resale of their products. In fact, any company would have been able to gain such control simply by affixing a copyrightable image or other work to an uncopyrightable product, such as a watch. Of course, as pointed out in Kirtsaeng v. John Wiley & Sons: No Good Deed Goes Unpunished, it remains to be seen whether this decision has a negative impact on the rest of the world, as publishers now have a disincentive to sell textbooks at a discounted rate in impoverished countries. See Roy Zwahlen, Kirtsaeng v. John Wiley & Sons: No Good Deed Goes Unpunished, PATENTLY BIOTECH (March 26, 2013).

United States v. Caronia After-The-Fact: What Was All That Fuss About, Again?

April 9, 2013
FDA, Pharmaceuticals

by Ashley Zborowsky, UMN Law Student, MJLST Notes & Comments Editor

In a split decision on December 3, 2012, the Second Circuit issued its long-awaited opinion in U.S. v. Caronia–a case concerning off-label promotion and commercial free speech. The 2011 U.S. Supreme Court holding in Sorrell v. IMS Health acknowledging off-label promotion to be “per se” protected under the First Amendment marked a significant shift in this area of law. Previously, the Food and Drug Administration (FDA) was able to recover billions of dollars in penalties from manufacturers engaged in off-label promotion, or the act of promoting regulated products for uses other than those approved by the agency. Despite other challenges on constitutional grounds, the FDA has been successful at defending its current practice–that is, until recently.

After Sorrell, it was unclear how the Second Circuit would apply this precedent in Caronia. For a robust discussion of the holding in Sorrell and alternate regulatory pathways to mitigate the effects of constitutional challenges to FDA authority, see Rethinking Off-Label Regulation in the Wake of Sorrell v. IMS Health: Can State Involvement Compensate for Waning FDA Authority to Curb Commercial Free Speech? Much to the agency’s chagrin, the Second Circuit found that truthful, non-misleading off-label speech is in fact protected by the First Amendment and therefore cannot be prosecuted under the Federal Food, Drug and Cosmetics Act (FDCA). Although the circuit court opinion is not binding outside of its jurisdiction and is only one early example of how Sorrell will be interpreted by lower courts, the Caronia decision signals potentially diminishing regulatory authority in this realm.

To be sure, the gradual constitutional erosion of its authority to police purported FDCA violations is a viable cause for concern–but is it imminent? Though analysts predicted a more panicked response on behalf of the agency, the FDA has apparently decided not to petition the U.S. Supreme Court for certiorari, stating that the agency “does not believe. . . the Caronia decision will significantly affect [ its] enforcement” of off-label promotion. Because of its limited precedential value and the fact that both Sorrell and Caronia only recognize speech that is truthful and non-misleading as protected, the Second Circuit decision may have very little practical effect. In fact just last month in a related case out of the Ninth Circuit, U.S. v. Harkonen, the court chose to ignore Caronia altogether–asserting that the First Amendment does not protect “fraudulent speech.”

While off-label promotion itself cannot form the basis of an FDCA violation under Caronia, it may still be introduced as evidence of criminal misbranding. As such, it seems that the Caronia uproar could have all been for naught. The FDA’s reaction (or lack thereof) to the Second Circuit’s holding indicates that this is likely true. If nothing else, however, Caronia will surely increase the number of constitutional challenges to FDA enforcement activity, forcing the agency to reexamine its priorities. Thus, while Caronia has the potential for wide-ranging implications down the line, industry stakeholders will just have to wait and see. Although Caronia has done little to alter the regulatory landscape presently, it may only be a matter of time before a circuit split begins to evolve.

United States v. Caronia After-the-Fact: What Was All That Fuss About, Again?

April 9, 2013
FDA, Pharmaceuticals

by Ashley Zborowsky, UMN Law Student, MJLST Notes & Comments Editor

In a split decision on December 3, 2012, the Second Circuit issued its long-awaited opinion in U.S. v. Caronia–a case concerning off-label promotion and commercial free speech. The 2011 U.S. Supreme Court holding in Sorrell v. IMS Health acknowledging off-label promotion to be “per se” protected under the First Amendment marked a significant shift in this area of law. Previously, the Food and Drug Administration (FDA) was able to recover billions of dollars in penalties from manufacturers engaged in off-label promotion, or the act of promoting regulated products for uses other than those approved by the agency. Despite other challenges on constitutional grounds, the FDA has been successful at defending its current practice–that is, until recently.

After Sorrell, it was unclear how the Second Circuit would apply this precedent in Caronia. For a robust discussion of the holding in Sorrell and alternate regulatory pathways to mitigate the effects of constitutional challenges to FDA authority, see Rethinking Off-Label Regulation in the Wake of Sorrell v. IMS Health: Can State Involvement Compensate for Waning FDA Authority to Curb Commercial Free Speech? Much to the agency’s chagrin, the Second Circuit found that truthful, non-misleading off-label speech is in fact protected by the First Amendment and therefore cannot be prosecuted under the Federal Food, Drug and Cosmetics Act (FDCA). Although the circuit court opinion is not binding outside of its jurisdiction and is only one early example of how Sorrell will be interpreted by lower courts, the Caronia decision signals potentially diminishing regulatory authority in this realm.

To be sure, the gradual constitutional erosion of its authority to police purported FDCA violations is a viable cause for concern–but is it imminent? Though analysts predicted a more panicked response on behalf of the agency, the FDA has apparently decided not to petition the U.S. Supreme Court for certiorari, stating that the agency “does not believe. . . the Caronia decision will significantly affect [ its] enforcement” of off-label promotion. Because of its limited precedential value and the fact that both Sorrell and Caronia only recognize speech that is truthful and non-misleading as protected, the Second Circuit decision may have very little practical effect. In fact just last month in a related case out of the Ninth Circuit, U.S. v. Harkonen, the court chose to ignore Caronia altogether–asserting that the First Amendment does not protect “fraudulent speech.”

While off-label promotion itself cannot form the basis of an FDCA violation under Caronia, it may still be introduced as evidence of criminal misbranding. As such, it seems that the Caronia uproar could have all been for naught. The FDA’s reaction (or lack thereof) to the Second Circuit’s holding indicates that this is likely true. If nothing else, however, Caronia will surely increase the number of constitutional challenges to FDA enforcement activity, forcing the agency to reexamine its priorities. Thus, while Caronia has the potential for wide-ranging implications down the line, industry stakeholders will just have to wait and see. Although Caronia has done little to alter the regulatory landscape presently, it may only be a matter of time before a circuit split begins to evolve.

Threats From North Korea: Switching Our Focus From Nuclear Weapons to Websites

April 8, 2013
Cyber Security, Internet, Law Enforecement

by Bryan Morben, UMN Law Student, MJLST Staff

There has been a lot of attention on North Korea and the possibility of a nuclear war lately. In fact, as recently as April 4, 2013, news broke that the increasingly hostile country moved medium-range missiles to its east coastline. It is reported that the missiles do not have enough range to hit the U.S. mainland, but is well within range of the South Korean capital. Tensions have been running high for several months, especially when the North took the liberty to shred the sixty year old armistice that ended the Korean War, and warned the world that “the next step was an act of ‘merciless’ military retaliation against its enemies.”

But perhaps the use of physical force by leader Kim Jong Un is not the only, or even the most important threat, from North Korea that the United States and its allies should be worried about. Despite the popular impression that North Korea is technologically inept, the regime boasts a significant cyber arsenal. The country has jammed GPS signals and also reportedly conducted cyber terrorism operations against media and financial institutions in the South. North Korea employs a host of sophisticated computer hackers capable of producing anonymous attacks against a variety of targets including military, governmental, educational, and commercial institutions. This ability to vitiate identity is one of the most powerful and dangerous parts about cyber warfare that isn’t possible in the physical world.

Susan Brenner is an expert in the field cyberwar, cybercrime, and cyber terrorism. She has been writing about how and why the institutions modern nation-states rely on to fend off the threats of war, crime, and terrorism have become ineffective as threats have migrated into cyberspace for over half a decade. Her article, Cyber-threats and the Limits of Bureaucratic Control, in Issue 14.1 of the Minnesota Journal of Law, Science & Technology outlines why we need a new threat-control strategy and how such a strategy could be structured and implemented. A strategy like the one Brenner recommends could help protect us from losing a cyberbattle with North Korea that most people aren’t even aware could happen.

Reviving GRAS(E): Bringing Reform to the Drug Approval Process

April 3, 2013
Food and Agriculture, Healthcare, Healthcare Reform, Pharmaceuticals, Public Health

by Maya Suresh, UMN Law Student, MJLST Staff

Bringing new drugs to the market has turned into a time consuming and costly process. Resulting in a process that takes roughly 12 years and 1.2 billion dollars to develop a single new drug and move it through the approval process, the current laws administered by the FDA have the potential to stifle potential economic growth. Current laws and FDA regulations require new drugs to go through three phases of clinical trials focusing on safety, optimal dosage, and effectiveness. It is in the prolonged third phase (where effectiveness is tested through extensive clinical trials) that many manufacturers decide to pull the drug from the program as the clinical trials threaten the firm’s financial viability. Ultimately, it is consumers that are hurt by the process, as they are unable to benefit from the drugs.

The negative effect on consumers is what Emily Puchalski hopes to eliminate with the recommendation detailed in her note published in Issue 14.1 of the Minnesota Journal of Law, Science & Technology. In “Bringing Dormant GRAS(E) to Bloom: Reviving The GRASE Concept for Drugs,” Puchalski suggests that a revival of the Food and Drug Administration’s (FDA) “generally recognized as safe and effective” laws and regulations, commonly reffered to as “GRASE”, could minimize the negative effects on consumers. Many drugs, once discovered, have formulations found in earlier drugs that have already been established as safe for consumer use. The GRASE law is grounded in this understanding, and provides a way for these “already established as safe” drugs to get to the market quicker without having to go through extensive clinical trials.

The problem with GRASE however, is that it is very difficult for a drug to achieve GRASE status. Due to this difficulty, GRASE has fallen out of use as manufacturers have stopped trying to achieve the status. Puchalski suggests that if the FDA were to revive GRASE, it could convince manufacturers to apply for GRASE status, allowing already established safe and effective drugs to come to market more quickly, thus benefiting consumers.

It would appear that Puchalski’s recommendation is being heard. In late February Micropharma Limited was able to obtain GRASE status for their new heart health probiotic. Ryan Jones, CEO of Micropharma Limited, echoed Puchalski when he spoke of the benefits the company has been able to reap with the highly coveted status. GRASE status will allow the company to accelerate development of the drug within both the United States and international markets. Further, it provides strong reputational benefits for the company, as it makes clear to the public that Micropharma is committed to investing a significant amount of time and energy into providing safe and effective drugs to the market.

The ability for Micropharma to obtain GRASE status could serve as evidence of a potentially reformed drug approval process. However, the full benefits realized by consumers and the market will only become clear with time.

Subpeona of Data Provided by Research Participants Under Confidentiality Agreement Raises Concerns

April 2, 2013
Bioethics, Criminal Law

by Sabrina Ly

On February 25, 2013, an article was published in The Dartmouth describing the implementation of its Committee for the Protection of Human Subjects. The purpose of the committee is to answer ethical questions and review proposals regarding human subjects participating in research at Dartmouth College. The committee is comprised of experts and community members “who analyze the risk posed to participants by Dartmouth-affiliated researchers’ studies.” The timing of its creation could be coincidental, but may have been in response to legal action taken against Boston College subpoening confidential data provided by research participants in the “Belfast Project” in 2012.

Prior to interviews taking place as part of the Belfast Project, researchers promised interviewees that their identities and information contained in the transcripts would not be released until after their deaths. However, upon discovering the existence of the transcripts, British law enforcement worked with the U.S. Department of Justice to subpoena the transcripts to use in its criminal proceedings. This raised significant ethical issues pitting the needs of law enforcement against the need for participant confidentiality in certain research that benefits the public.

The problem of subpoenaing confidential human research information is further elaborated in an article recently published in Issue 14.1 of the Minnesota Journal of Law, Science and Technology. In Certificates of Confidentiality: Protecting Human Subject Research Data in Law and Practice, Wolf, et al., discuss the importance of enforcing a certificate of confidentiality in human research studies. Confidentiality in order to obtain information from human subjects during research is vital to progression and understanding in health, science and many other fields. Often research requiring a promise of confidentiality involves difficult and controversial subjects that would be nearly impossible to study without an assurance of confidentiality.

A certificate of confidentiality encourages individuals to volunteer information they might not otherwise be willing to disclose by protecting their identity and privacy. By breaking the promise of confidentiality, the subpoenaing of the “Belfast Project” threatens academic freedom, and may deter future research participants from providing accurate personal information. Such reluctance to provide information could harm the work of researchers who might otherwise advance understanding and provide valuable insights on difficult issues. One example in which research is difficult without confidentiality is the willingness of individuals to share information about their sexuality, sexual behaviors, or drug-using behaviors. In past studies, researchers have been able to use this information to derive how HIV spread and implement methods to prevent the spread.

The broad benefits to society of upholding academic freedom, the right to privacy, and freedom of information, far outweigh any claim law-enforcement may have to subpoena confidential research data. While an individual prosecution may be important, the damage caused by allowing such a breach of confidentiality could greatly hinder society-benefiting research. The importance of enforcing certificates of confidentiality to prevent the criminalization of human research subjects is significant.

Boston College has filed a petition for a writ of certiorari in the Supreme Court to appeal the First Circuit’s ruling upholding the subpoenas.

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