FDA Breaks Its Own Regulations
Most people believe that the FDA needs to ensure that the medicines we Americans consume have been proven to be safe and effective long before we ever get a chance to use them. Yet the Makena story gives us a peek into an area of medical practice where unproven “homebrew” drugs rule the market, where even the FDA seems to agree that FDA approval is superfluous. Is there a bigger lesson here?
A former commissioner of the FDA, David Kessler, once stated, “If members of our society were empowered to make their own decisions about the entire range of products for which the FDA has responsibility, however, then the whole rationale for the agency would cease to exist.” He has a point. [Italics added.]
These are the closing paragraphs of the November Econlib Feature Article, “Never Mind: FDA Changes Own Rules in Midstream,” by Charles L. Hooper.
In the article, Hooper shows how the FDA gave a monopoly on the drug Makena to a company called KV Pharmaceutical, making it illegal for compounding pharmacies to produce their own as they had been doing for years. The best solution would have been not to give the monopoly in the first place and let the compounding pharmacies do what they had been doing for years. But the FDA thought that it needed to go back and insist on evidence of safety and efficacy and give a monopoly to the company that did so. Then, when Congress pressured the FDA, it broke its own rules and allowed compounding pharmacies to undercut the legal monopoly. So did the FDA think that it needed proof of safety and efficacy? Apparently not. As Hooper points out, there’s a bigger lesson here.