According to a report by the inspector general of the Department of Health and Human Services, the U.S. FDA has not made tracking post-approval drug studies a priority, and does not know the status of many of them.
Roughly half of all drug approvals involve a commitment by the manufacturer to at least one post-approval study commitment.
Companies are required to give the FDA annual progress reports on these studies, but 35 percent of the reports due in 2004 were either missing entirely or contained no relevant information. The FDA validated less than a third of the reports. The FDA has little to no power to punish drug companies that leave such studies unfinished.
The inspector general said the FDA should improve its monitoring of the studies, upgrade its tracking system, and ask manufacturers to provide better information.
Remember all those promises the FDA made to improve drug safety to protect the health of Americans, especially those that were blasted by the Pharmaceutical Research and Manufacturers of America? This report makes those promises ring very hollow. Once the drugs are on the market, the FDA virtually stops paying any attention whatsoever to whether or not they might cause harm.
There are a number of good reasons for this, one of the primary ones being that they have never been funded to do this, as the powerful drug lobby cleverly helped to ensure that over 80 percent of their resources are directed to approving drugs, with a measly 5 percent directed to drug safety.
The FDA's real purpose now is to give a seal of approval to drugs produced by their industry "partners," even if the drugs are dangerous or useless.
Of course, the FDA's commissioner, Andrew von Eschenbach, denies any wrongdoing, no matter how damning the evidence. More proof than ever that you can't count on the FDA, as it's currently configured, to protect your health.
This is in part because, when the Prescription Drug User Fee Act took effect in 1992, the drug companies actually started to fund the FDA. I assure you that this is true. It's the classic case of the fox guarding the henhouse. How can you possibly trust a system in which the people who approve the drugs are being paid by the people who make the drugs?
The system has inevitably led to rampant conflicts of interest. The most egregious recent example of this was when 10 of the 32 FDA drug advisers whose total votes favored the controversial painkillers Celebrex, Bextra and Vioxx had financial ties to the drug industry.
So wake up if you haven't already done so and realize that the FDA's primary purpose is to help multi-national drug companies increase their profits.