New Report: The FDA’s Misguided Regulation of Stem-Cell Procedures

How administrative overreach is blocking medical innovation

NEW YORK, NY – On Tuesday, September 24, 2013, the Manhattan Institute’s Center for Legal Policy released a report on the FDA’s role in regulating adult stem-cell medical procedures. In this paper, Richard Epstein discusses Regenerative Sciences LLC v. United States, a case now pending before the U.S. Court of Appeals for the D.C. circuit, in which two doctors are challenging an FDA enforcement action against an orthopedic stem-cell procedure they developed.

This paper analyzes the government’s position on both legal and policy grounds. The legal analysis focuses on three aspects of the government’s argument:

• Interstate Commerce: The government incorrectly reads the statutory power conferred on the FDA through the “interstate commerce” clause of the Federal Food, Drug and Cosmetic Act of 1938 (FFDCA) as identical to the federal government’s broad authority under the Commerce Clause of the U.S. Constitution. The text, structure, and history of the statute, however, command a narrower reading of the clause, which clearly places the doctors’ procedure—in which the patient’s own cells never leave the in-house laboratory before being re-injected into the same patient—outside the FDA’s regulatory reach.
• Drug vs. Practice of Medicine: The government improperly classifies the stem cells which are removed from and re-injected into the same patient as “drugs” subject to FDA regulation rather than the “practice of medicine,” the regulation of which Congress has traditionally left to the states.
• Communicable Diseases: The government also claims that the FDA may regulate the Regenerative Sciences doctors’ stem-cell procedures under the 1944 Public Health Service Act, which gives the agency the authority to prevent the spread of communicable diseases. Whatever risks this stem-cell procedure might create for patients—and there are no documented cases of adverse side effects cited by the FDA—such risks would not involve communicable diseases.

From a policy standpoint, Epstein argues that the FDA’s broad assertion of regulatory authority in this case highlights the disconnect between the agency’s review standards and the new style of personalized medicine. Subjecting personalized medical solutions such as the Revolutionary Sciences doctors’ stem-cell procedures to the same oversight that is given to large drug manufacturers in the design and production of new products for the mass market would stifle such innovations—which, if unimpeded, promise to revolutionize the delivery of health care. A single physician or hospital cannot afford the high costs of this kind of FDA compliance, so many of the innovative treatments they develop will not become available to patients.

Richard Epstein is a Manhattan Institute visiting scholar and one of the nation's most prolific legal thinkers. Epstein's writings span a broad array of fields, from the common-law subjects of property, contracts, and torts to constitutional law and law and economics.