Kratom leaves and capsules.

A Sensible, Evidence-Based Proposal for Kratom Reform

By Dustin Marlan

In May 2021, the U.S. Food and Drug Administration (FDA) announced the seizure of 37,500 tons of adulterated kratom in Florida, worth an estimated $1.3 million.

But rather than focusing on the fact that the seized substance was adulterated, FDA Commissioner Janet Woodcock emphasized the alleged toxicity of kratom. This telling choice falls in line with recent efforts by the FDA to end U.S. kratom sales, distribution, and use, including a failed 2016 attempt to have kratom placed into Schedule I of the Controlled Substances Act, along with other federally prohibited drugs such as cannabis, psilocybin, and heroin.

This reactionary prohibitionism is likely to do more harm than good. Moreover, it does not reflect the state of the science, which remains unsettled as to kratom’s risks and benefits.

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Pile of colorful pills in blister packs

Expanding The Right to Try Unproven Treatments: A Dangerous, Deregulatory Proposal

By Richard Klein, Kenneth I. Moch, and Arthur L. Caplan

A new proposal out of the Goldwater Institute (GI), a libertarian think tank, advances an oversimplified critique of the U.S. regulatory process for approving medicines for COVID-19 and other diseases, with the ultimate goal of weakening the U.S. Food and Drug Administration.

You may remember the Goldwater Institute as the architect of the initial state “Right to Try” (RtT) legislation from a few years ago. The idea, marketed as increasing access to experimental medicines, was actually calculated to circumvent FDA oversight so that individuals could try still-unproven experimental medicines without what Goldwater viewed as pointless bureaucratic paternalism. RtT legislation was adopted by 41 states and ultimately by the U.S. Congress.

When former President Trump signed the Right to Try bill into federal law with great fanfare on May 20, 2018, he stated that “countless American lives will ultimately be saved.” Three years later, the promise proved to be meaningless, as evidenced by the difficulty in identifying more than a handful of individuals who have even pursued the RtT pathway, much less finding data to show that it has saved lives.

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Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

A New Step for the FDA in Regulating Digital Health Products

By Vrushab Gowda

On September 22, the U.S. Food and Drug Administration (FDA) announced the establishment of a new initiative to regulate digital health products – the Digital Health Center of Excellence (DHCoE).

In some ways, the announcement does not come as a surprise; FDA Commissioner Stephen Hahn’s predecessor, Scott Gottlieb, outlined the DHCoE in a press release two years ago. What does remain to be seen is whether DHCoE represents a true paradigm shift in FDA’s approach to regulating digital health products.

According to Hahn, the DHCoE aims to (1) build partnerships, (2) share knowledge across FDA and with stakeholders, and (3) innovate regulatory approaches. It will be led by the current Director of CDRH’s Division of Digital Health, Bakul Patel.

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Person typing on computer.

Telehealth Policy Brought to the Fore in the COVID-19 Pandemic

By Vrushab Gowda

The COVID-19 pandemic has highlighted the value of telehealth as both a tool of necessity (e.g., minimizing infection risk, conserving thinly stretched healthcare resources, reducing cost) as well as of innovation.

Telehealth services have surged in recent months; in April alone, they constituted over 40 percent of primary care visits nationwide and over 73 percent of those in Boston. “Increasing Access to Care: Telehealth during COVID-19,” a recent publication in the Journal of Law and the Biosciences, dissects the issues that have accompanied the growth of telehealth and identifies further areas of potential reform.

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Tomorrow (1/29): A “Natural” Experiment: Consumer Confusion and Food Claims, a lecture by Efthimios Parasidis

A “Natural” Experiment: Consumer Confusion and Food Claims, a lecture by Efthimios Parasidis

Thursday, January 29, 2015, 12: 00 PM

Wasserstein Hall, Milstein West B                               Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA [Map]

This event is free and open to the public. Lunch will be served.

Efthimios Parasidis is Associate Professor at The Ohio State University Moritz College of Law and holds a joint appointment with the College of Public Health. He is an inaugural member of College of Medicine’s Center for Bioethics and Medical Humanities. His scholarship focuses on the regulation of medical products and human subjects research, the interplay between health law and intellectual property, and the application of health information technology to public health policy. He has published in leading law reviews and health policy journals, is co-authoring a casebook, and has a book under contract with Oxford University Press. The Greenwall Foundation awarded Professor Parasidis a Faculty Scholar in Bioethics fellowship for 2014-2017.

The lecture will be followed by an audience question and answer session moderated by Jacob Gersen, Professor of Law at Harvard Law School and Director of the Food Law Lab.

Cosponsored by the Food Law Lab and the Harvard Food Law and Policy Clinic at Harvard Law School.

Upcoming Event (1/29): A “Natural” Experiment: Consumer Confusion and Food Claims, a lecture by Efthimios Parasidis

A “Natural” Experiment: Consumer Confusion and Food Claims, a lecture by Efthimios Parasidis

Thursday, January 29, 2015, 12: 00 PM

Wasserstein Hall, Milstein West B                               Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA [Map]

This event is free and open to the public. Lunch will be served.

Efthimios Parasidis is Associate Professor at The Ohio State University Moritz College of Law and holds a joint appointment with the College of Public Health. He is an inaugural member of College of Medicine’s Center for Bioethics and Medical Humanities. His scholarship focuses on the regulation of medical products and human subjects research, the interplay between health law and intellectual property, and the application of health information technology to public health policy. He has published in leading law reviews and health policy journals, is co-authoring a casebook, and has a book under contract with Oxford University Press. The Greenwall Foundation awarded Professor Parasidis a Faculty Scholar in Bioethics fellowship for 2014-2017.

The lecture will be followed by an audience question and answer session moderated by Jacob Gersen, Professor of Law at Harvard Law School and Director of the Food Law Lab.

Cosponsored by the Food Law Lab and the Harvard Food Law and Policy Clinic at Harvard Law School.

The FDA Strikes Again: Its ban on home testing kits is, as usual, likely to do more harm than good

Cross-post from PointOfLaw.

Richard A. Epstein is a professor of law at NYU Law School, a Senior Fellow at the Hoover Institution, a Senior Lecturer at the University of Chicago and a visiting scholar with the Manhattan Institute’s Center for Legal Policy. His forthcoming book is “The Classical Liberal Constitution,” from Harvard University Press.

On November 22, 2013, the Food and Drug Administration flexed its regulatory muscle by sending a warning letter to a genetic-testing company that goes under the stylish name of 23andme. The object of FDA scorn was a diagnostic kit that the tech company, backed by among others Google and Johnson & Johnson, sold to customers for $99. The kit contained an all-purpose saliva-based test that could give customers information about some 240 genetic traits, which relate to a wide range of genetic traits and disease conditions. The FDA warning letter chastised 23andme in no uncertain terms for being noncooperative and nonresponsive over a five-year period in supplying information that the FDA wanted to evaluate its product as a Type III device under the Medical Devices Act.

Legal Regulation of 23andme

There is no doubt that the FDA is on solid legal ground. This case is not like the processes involved in Regenerative Sciences, LLC v. United States, where the FDA asserted that physicians’ use of certain stem-cell procedures for joint disease involved the use of a drug that required FDA approval before it could be approved for use. In an earlier essay for the Manhattan Institute, I argued that this classification was in fact both legally incorrect and socially mischievous. In this case, the legal arguments are not available to 23andme because the current definition of “medical devices” covers not only those devices intended for use on the human body, but also those used for the diagnosis of disease. The Type III classification means that this device has to receive premarket approval from the FDA, which in turn requires that it be shown to be safe and effective for its intended use. Getting approval under this standard is arduous business, because any such approval must be for each of the tests separately. 240 tests thus require that number of approvals. The costs are prohibitive, and the delay enormous.

The FDA Warning Letter is significant both for what it says and for what it does not say. Read More