New York Times and Reader’s Digest Address Problem of Preemption in Drug Cases, Part II

Let me start off by saying that NO, I am not a regular or avid reader of Reader’s Digest. Have to say, I always considered it a publication for my Mom and Dad to read. Of course, now at the ripe old age of 48, I guess I have now become my Mom and Dad and the world has come full circle. Anyway, I digress. In the April Edition of Reader’s Digest, a very insightful article has been published entitled What’s Ailing the FDA? In it the author discusses the overworked and underfunded FDA and how it is not able to do the job it is assigned to do, protect the public from dangerous food and drugs. A couple key points in the article bear mentioning:
1. The funding provided for this agency to do its job of regulating food, drugs, vaccines, medical devices, cell phones, dietary supplements and biotechnology is equivalent to what a county school system in Virginia is provided. The FDA’s own advisory Science Board commissioned a report which led one of the members of that Board to say, “We were shocked at the appalling state of science at the FDA.” The Institute of Medicine has labeled the drug branch of the FDA “dysfunctional”, indicating it quiets those at the FDA who disagree, inadequately monitors drug safety and relies too much on the financial support of the drug companies, who it is given the job to regulate.
2. Pressure of the Drug Industry: Big Pharma pressures the FDA to speed up decisions on drugs so it can get the drugs to the market and make money, and to soft-pedal problems with the drugs. The article points out that Big Pharma now pays for over half of the budget of the FDA for drug review. This money comes from Big Pharma through user fees the drug companies pay the FDA to speed the drug review process. As the article suggests, it may save taxpayers money, but it calls into question the independence of the FDA when making decisions.
Moreover, there has been a big push by the drug companies for faster approval of drugs i.e. get on the market quicker so the money comes in quicker. We can all agree that getting important lifesaving drugs on the market quicker is important. Who can dispute that pushing through the approval of a drug that can cure a certain type of cancer is not important. However, when this same pressure is used to push through approval of a “life style” drug, like something to help with “restless leg syndrome” ( a condition the drug companies came up with so it could have a disease for its drug to treat), the FDA is not able to fulfill its role of really addressing the potential safety issues with these drugs. The FDA denies the overriding influence of the pharmaceutical industry in making its decisions, but the truth lies in the results. Think Vioxx, Ortho Evra, Baycol, Singulair, Chantix…and the list goes on and on. All these situations have shown that the FDA was not given complete information about a drug, or the drug company failed to disclose all the information it had. Instead the drug companies pushed like hell to get its drug to market for the almighty dollar.

Related Topics: Drugs, Pharmaceutical Companies, Preemption