Aredia, Baycol, Bextra, Celebrex, Fen Phen, Rezulin, Vioxx, and Zyprexa. These are all drugs that were “approved” by the FDA. Does FDA approval mean that the FDA tested these drugs itself? No! The FDA does not have the resources to test the food, medical devices, and drugs it is empowered to regulate. The FDA relies upon the manufacturer seeking approval of its drug or device to test its own product. The manufacturer’s clinical trials, animal studies, and other test data is submitted to FDA advisory panels for review. The FDA does not have adequate staff to look behind the data the manufacturer chooses to share with the FDA. How many times in the past 15 years has the FDA learned after approving a drug that the manufacturer withheld or hid during the drug approval process critical safety or efficacy information. Oops, we forgot to submit that offshore clinical trial that showed a strong association between our drug and strokes! To compound the problem, the FDA advisory panels are fraught with conflicts of interest. It is not uncommon for the manufacturer seeking approval of a drug to have paid consulting fees to members of the FDA advisory panel charged with regulating the drug.
The most recent example of the fallacy of treating FDA approval as some sort of gold standard is the heparin debacle. American companies like Scientific Protein Laboratories, which supplied the contaminated heparin to Baxter International, which manufactured and distributed the finished heparin, have decided to outsource supply and production for some of their products to China. In the case of heparin, the pig intestine product is coming from the bowels of rural China. The FDA has now identified Changzhou, SPL, a Chinese subsidiary of Scientific Protein Laboratories, as the source of the contaminated heparin that has killed over 80 people. According to a Congressional investigator, the contaminated crap used by Chagzhou cost $9.00 a pound compared with $900.00 a pound for heparin. Once again, Americans are being killed unnecessarily because a company put profits over safety.
And get this! The FDA admits it neglected to inspect the Changzhou plant, and China is now refusing to permit the FDA to inspect the plant in the future. Does this sound like the FDA has the wherewithal to guarantee the safety of a product that gets injected into the bloodstream?
Incredibly, the argument put forth in products liability cases involving unsafe drugs by the Administration and the Supreme Court in favor of denying an injured American his or her Seventh Amendment right to a trial by jury boils down to the fact that the drug was “FDA approved.” Yet, the bipartisan consensus in Congress is that the FDA needs a rapid increase in its budget to be able to ensure the safety of the nation’s drugs, medical devices, and food. The Bush Administration’s response was to propose a budget for the FDA that does not even cover its expected cost increases. It’s time to take cronyism out of this equation. Product safety must be the goal, not appeasing the interests of the drug manufacturers. Until the FDA has the resources to ensure product safety, the concept of federal preemption of drug cases is a joke.