A reader asks us to clarify.
In response to Part One of our article on laws threatening integrative physicians and integrative medicine, Chad wrote:
Your article explains the difficulties that doctors encounter when [prescribing] compounded drugs for their patients that have not been approved by the FDA. But it also implies (quoting federal law) that it is legal for doctors to do so. This runs counter to stories I have heard about what a doctor really can and cannot [do]. Would you please provide further clarification?
Thank you, Chad, for highlighting an important area of the law as applies to doctors’ ability to prescribe “unapproved” drugs. In our article, we noted the following:
Federal law clearly states that licensed physicians may “manufacture, prepare, propagate, compound, or process drugs solely for use in the course of their professional practice” [21 USC 360(g)]. Furthermore, the Federal Food, Drug, and Cosmetic Act (FD&C) cannot regulate the therapeutic practices themselves.
There are problems, however. While practitioners might have the theoretical right to manufacture their own drugs, from the practical point of view the FDA takes a very expansive view of its authority and jurisdiction. For example, the rule stated above has been narrowly defined in at least the area of cancer treatment to apply only to intrastate activities. A report from the congressional Office of Technology Assessment, “Unconventional Cancer Treatments,” outlines the law at that time: “It is legal for physicians to prescribe treatments they manufacture that are unapproved by FDA, but only in the State in which they manufacture the treatments. It is illegal to transport unapproved drugs across State lines and laws pertaining to good manufacturing practices apply to physicians as well as to commercial medical manufacturers.”
It gets worse. The FDA holds that an “interstate commerce” test must be applied to all steps in a product’s manufacture, packaging, and distribution. This means that if any ingredient—even one test tube—used in the compounding of an unapproved drug was purchased out of state, the FDA would in its view have jurisdiction, as they would if the final product were to travel across state lines.
This report may or may not reflect the FDA’s current position on prescribing unapproved drugs as it was published several years ago, and we simply won’t know the FDA’s current thinking until they officially weigh in again. Any doctor wondering about this must consult with his or her own legal counsel and try to make sense of what is really senseless.
This is unfortunately part of a much larger problem. The FDA has shown us historically that it acts as a law unto itself, acting as executive agency, legislator, and judge all in one, although clearly forbidden to do so by the Constitution. If you don’t like it, you can sue, but the FDA has an unlimited legal budget and you don’t. That is part of the agency’s scare tactics—if you oppose us, we will bankrupt you or, if possible, put you in jail.