Patricia J. Zettler

The Strange Allure of State “Right-to-Try” Laws

State right-to-try laws revive a decades-long debate about balancing early access to unapproved medications for terminally ill patients with requirements for demonstrated safety and effectiveness. Although the legal approach is novel, there are many reasons to believe that the laws are likely to be futile. The laws also raise questions about the roles of the state and federal governments in overseeing drugs and medical devices.

23andMe, the Food and Drug Administration, and the Future of Genetic Testing

On November 22, 2013, the US Food and Drug Administration (FDA) effectively halted health-related direct-to-consumer genetic testing in the United States by sending a warning letter to 23andMe, the leading company in the field, directing it to stop providing such testing. The FDA acted as the era of widespread, clinical use of DNA sequencing rapidly approaches. The agency’s action will contribute to changes in which genetic tests are offered to patients and how testing is provided.

tDCS Research in a World With FDA Regulation

Wexler and Hamilton’s (2017) editorial on crowdsourced transcranial direct current stimulation (tDCS) research discusses the potential for such research to produce scientifically valuable information, the methodological obstacles to it actually doing so, and related ethical concerns. For example, a central concern is that because of the variability in the devices themselves and in what individuals aim to achieve through their tDCS use—including a range of enhancement and treatment goals—it may be difficult to draw any general conclusions from aggregated information about individual use. Wexler and Hamilton ultimately observe that some entity would need to take control over crowdsourced tDCS research to overcome the myriad methodological obstacles. Building on their observations, this commentary begins to explore how U.S. Food and Drug Administration (FDA) regulation of tDCS products might affect both industry-sponsored and crowdsourced studies of commercially produced tDCS products intended for home use. Specifically, this commentary makes the case that the FDA exercising its authority to regulate in this area may have informational benefits by incentivizing greater research rigor. If realized, these benefits would be socially valuable because there is great hope for and hype about tDCS use, and consumers, currently, can access these products with relative ease. However, few clinical trials have studied the home use of tDCS (Bikson et al. 2016) such that its efficacy and long-term safety are uncertain.

Anticipating Industry Arguments: The US Food and Drug Administration’s Authority to Reduce Nicotine Levels in Cigarettes:

The US Food and Drug Administration has announced that it is considering lowering nicotine levels in cigarettes to “minimally addictive or nonaddictive levels.” This could be a transformative public health measure, but the tobacco industry is likely to challenge such an action in court. This article reviews some of the key legal arguments that industry is likely to advance and considers possible responses. As we demonstrate, there are strong arguments that the US Food and Drug Administration has the authority to implement a policy to reduce nicotine in cigarettes to nonaddictive levels.

Promoting Patient Interests in Implementing the Federal Right to Try Act

On May 30, 2018, President Trump signed into law the federal Right to Try Act of 2017,1 providing patients with life-threatening conditions a pathway to access investigational drugs without authorization from the Food and Drug Administration (FDA). Ethicists, physicians, and patient groups have raised concerns about this type of legislation at the state and national levels given its implications for patients and the FDA’s public health mission.2,3 Now that “Right to Try” has become federal law, however, there is an opportunity to clarify statutory ambiguities that may help minimize the law’s potential to cause harm and advance its goal of encouraging companies to provide preapproval access to investigational drugs.