Thursday, February 21, 2008

What A Doctor Employed by the FDA said about the FDA

Continuing on the Riegel set of posts, it seems that those applauding the decision conclude that if the FDA can just get funded properly, we'll be fine.

I wanted to see what someone within the FDA thinks of the FDA, and I found:
Dr. David Graham, Associate Director for Science and Medicine in FDA's Office of Drug Safety. He provided testimony to a Senate Committee on the FDA's failures. Compelling stuff.

On one website, you can read this, among other things (and remember this is from someone within the FDA): "I would argue that the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless."


It is important that this Committee and the American people understand that what has happened with Vioxx is really a symptom of something far more dangerous to the safety of the American people. Simply put, FDA and its Center for Drug Evaluation and Research are broken.

In 1938, Congress enacted the Food, Drug and Cosmetic Act, basically creating the FDA, in response to an unfortunate incident in which about 100 children were killed by elixir of sulfanilamide, a medication that was formulated using anti-freeze. This Act required that animal toxicity testing be performed and safety information be submitted to FDA prior to approval of a drug.

In 1962, Congress enacted the Kefauver-Harris Amendments to the FD&C Act, in response to the thalidomide disaster in Europe.

In my opinion, the FDA has let the American people down (addressing the Vioxx debacle), and sadly, betrayed a public trust. I believe there are at least 3 broad categories of systemic problems that contributed to the Vioxx catastrophe and to a long line of other drug safety failures in the past 10 years.

Read more here.