As politicians wrangle about the roll-out of the federal government’s newest program subsidizing and regulating health care in America, Washington regulators are stretching old laws in new directions that threaten medical innovation.
On Oct. 21, the U.S. Court of Appeals for the D.C. Circuit will hear arguments in a case, USA v. Regenerative Sciences, in which the federal Food and Drug Administration threatens to usurp long-standing state regulation of the practice of medicine.
The case involves medical procedures developed by two Colorado doctors in which stem cells from a patient’s blood and bone marrow are re-injected into the patient’s joints to treat joint ailments.
In 2008, the FDA effectively shut down the doctors’ work — notwithstanding the absence of any documented adverse side effects — by asserting regulatory authority over their procedure, under the premise that the patient’s own stem cells cultivated solely for his own use are “drugs” subject to the agency’s oversight.
As New York University law professor Richard Epstein explains in a new paper for the Manhattan Institute's Center for Legal Policy, this federal power grab makes a mockery of the longstanding distinction between the regulation of drugs and medical devices, which fall under the FDA's purview, and the practice of medicine, which has traditionally been regulated by the states.
A medical procedure in which a single patient’s own body fluids are re-injected into his body hardly looks like a “drug” as the term is commonly understood, and the doctor’s medical procedure is a far cry from the interstate marketing of discrete chemical compounds across a diverse population.
In arguing its case before the courts, the government makes much of the federal constitution's Interstate Commerce Clause, which in the Supreme Court's modern rendering gives Congress vast powers over economic activities.
But this argument misses the point: Though it is doubtless the case that Congress could regulate even local medical practice without violating the Constitution as the courts have interpreted it, it does not follow that Congress has actually done so in the specific statute in this case, the 1938 Federal Food, Drug, and Cosmetic Act.
In this case, the history and structure of the statute (which predates the Supreme Court’s decision to stretch the Interstate Commerce Clause to empower congressional action virtually without bounds) strongly supports a narrower reading. The government’s present reading is essentially that the FDA can regulate anything it wants to if it involves something to do with medicine.
FDA regulation of medical procedures like the Colorado doctors’ is a death knell, since the agency’s protocols — which entail multistage double-blind clinical trials across a large sample of individuals — simply don’t fit with such small-scale, personalized medicine.
Even were clinical trials empirically possible for the doctors’ procedure, they would be prohibitively time-consuming and costly, given that FDA trials typically take years and cost billions of dollars.
Indeed, the Regenerative Sciences case highlights the disconnect between the FDA’s regulatory requirements and the most promising area of medical innovation, which involves personalized and genomic solutions.
Long-duration, expensive trials may make sense for widely sold “blockbuster” drugs, but they simply stop research related to cures without the broadest applications, including many rare cancers and diseases.
Although most public debate involving stem-cell-based medical research has surrounded whether the federal government should subsidize such research when it involves cells taken from embryos, the FDA’s decision to scuttle promising innovations that use stem cells taken from adult patients for their own treatment has received scant attention.
Regardless of how the D.C. Circuit rules in Regenerative Sciences, Congress would be well-advised to rethink the FDA’s regulatory approach.James R. Copland is the director of the Center for Legal Policy at the Manhattan Institute.