Maybe the Drug Companies Should Clean Up This Mess

In keeping with the previous post on the woes of the underfunded FDA, the New England Journal (which no doubt takes their cues from this blog) ran two commentaries on the FDA's ability to guarantee the safety of the U.S. prescription drug supply in its April 24 issue. Mostly this was going over well-known ground, but I was struck by the suggestion made by Dr. Alastair J.J. Wood of Cornell. (It's my understanding that Dr. Wood was widely thought, in the past, to be the most logical person with the greatest relevant expertise to become the Commissioner of the FDA, and was not given that job because he was insufficiently pro-business. If true, that's a deficiency that Dr. Wood appears now to be eager to remedy, as NEJM states that he's "managing director of Symphony Capital" and also has received lecture fees from PhRMA.)

However, in comments that I doubt were paid for by the drug industry, Dr. Wood offers a counterpoint to the general clamor for FDA accountability for allowing poisonous chemicals to enter the U.S. drug supply via China. He offers the refreshing proposal that the drug companies should instead be held responsible for this and the FDA should basically admit that it has no control over these matters. After all, Dr. Wood reminds us, why are these shady Chinese companies in the loop at all? It was the American or global drug companies' own business plans that led them to decide that they could make a fast buck by outsourcing their chemical supply sources. Since they presumably made extra profits by buying cheaper ingredients for their drugs, they can reinvest some of those earnings in taking whatever steps are needed to assure quality and safety of the drugs that they peddle--or else be held fully accountable for foisting poisons on the American public.

As explained in HOOKED, this shows the ambivalent relationship that is set up by the phenomenon of "regulatory capture" of a Federal agency by the industry it is supposed to regulate. The drug companies are walking a very fine line. They want the FDA to be rendered sufficiently toothless as to be unable to take any actions that cause any inconvenience or lowered profits for them. But at the same time they want the FDA to appear powerful and threatening enough so that they can turn around and blame the FDA oversight process whenever a scandal arises like tainted Chinese-made heparin. Ditto for the present efforts of the industry to support FDA rules changes that would allow companies to market drugs off-label by circulating reprints from medical journals (based on the assumption that the FDA stringently regulates this process so that no false information could ever get through), and to convince the U.S. Supreme Court that they should be shielded from any legal liability in relation to any drug that has been FDA approved (again assuming that the FDA approval process is so stringent that the public needs no additional safeguards).

Wood AJJ. Playing "kick the FDA"--risk-free to players but hazardous to public health. N Engl J Med 358:1774-75, April 24, 2008.