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Editor: Tim O'Brien
Profession: Attorney at Law

A recent study published in the New England Journal of Medicine confirms that the FDA does not presently have sufficient power to protect the American public from the adverse effects of drugs.

As you may recall, after the late 2004 Vioxx debacle, the FDA came up with a 4 part plan to see how it can prevent future pharmaceutical catastrophes such as that with Merck's Vioxx. In typical fashion, two years later, no real changes have occurred. However, the published study provides a glimmer of hope that some brave soul in Washington will take on the pharmaceutical industry and empower the FDA to protect the American public.

One part of the plan was to charge the Institute of Medicine with the task of looking at the way FDA works and how it should be changed. The New England Journal of Medicine just published the IOM's recommendations and they are unequivocal: the Congress needs to massively overhaul the FDA.The link below will take you to a radio interview with the lead author, Dr. Bruce Psaty. Dr. Psaty's generic recommendation that the "FDA needs to develop a culture of safety" that does not presently exist.

In the 1990s, the Congress passed a law that sped up the drug approval process in the United States. The User Fee amendments required drug companies to pay application fees with each New Drug Application filed. While these revenues sped up the U.S. drug approval process, pharmaceutical lobbyists were able to have Congress include a section which specifically prohibits using any of those revenues for purposes of post-marketing safety surveillance.

As a result, whereas in the 1980s, the U.S. was the site of first launch for only 5% of drugs worldwide, in the late 1990s, it became the site of first launch for 65% of the drugs and the U.S. consumer became the world's pharmaceutical guinea pigs.

Dr. Psaty says that Congress needs to give FDA additional powers because the powers it has right now are woefully insufficient to make pharmaceutical companies do anything. At the present time, short of pulling a drug off the market, the FDA cannot force a pharmaceutical company to do anything. It has to plead and cajole for it to change its warnings. This is why Merck was able to not implement the warnings language the FDA requested for Fosamax in its August 2004 Office of Drug Safety review of the class effect of osteonecrosis of the jaw.

The attorneys at Levin Papantonio have been saying for years that the FDA is too anemic to force Big Pharma to do much for consumer safety. Dr. Psaty's panel feels the same way.

The panel concluded that the FDA needs specific authority to: (1) change labels rapidly; (2) ensure postmarketing (Phase IV) studies commence immediately upon the marketing of a drug for the specific purpose of testing the safety of the drug in the real world setting; (3) ensure that the Phase IV studies are timely complete and accurately reported; and (4) quickly require (not ask or beg) the drug companies to change labeling to accurately reflect the associated risks.

Here's a link to the interview with Dr. Psaty.

http://content.nejm.org/cgi/content/full/355/17/1753/DC1