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Editor: Tim O'Brien
Profession: Attorney at Law

In reviewing the FDA files on Merck and Fosamax, it was interesting to learn that the FDA had on several occasions in the late 1990s sent formal letters of criticism to Merck for overstating the benefits of Fosamax and, perhaps more importantly, underemphasizing the risks associated with Fosamax use. Letters were sent on the following dates: 04/14/97; 07/02/97; 07/16/99; 06/20/01. Links to the letters can be found at the bottom of this entry.

Undoubtedly, these letters would have continued through the 2000s. However, in late 2001, after the federal administration changed hands and political appointments more friendly to Big Pharma took over, a new policy was instituted that prohibited the FDA's Division of Drug Marketing, Advertising & Communications (DDMAC) from sending out warning letters to pharmaceutical companies unless the letters were previously approved by the FDA's General Counsel.

Well, here's the problem: The employees at DDMAC are lifelong FDA employees whose sole job is to make sure that the pharmaceutical companies are telling it straight to the consuming public. The General Counsel is a political appointment who serves at the request of a politician who is largely beholden to his donating patrons at Big Pharma. This General Counsel, rather than protect the American public from defective drugs, would actually write letters to federal judges asking that they dismiss cases of injured victims before the victims even had the opportunity to present to the Court exactly what it was the pharmaceutical company did wrong.

As a result, the FDA General Counsel significantly shut down the warning letters being sent by DDMAC to pharmaceutical companies in late 2001 and now pharmaceutical companies have much greater freedom to hide the risks and overstate the benefits of their drugs.

Apparently, the FDA General Counsel was either (1) too busy writing to federal courts asking that victims of defective drugs be denied their day in court or (2) not inclined to review and approve important DDMAC warnings letters to Big Pharma. The drug companies have plenty of attorneys of their own - - they should not have the right to the have taxpayer-funded Office of General Counsel serve their fancies as well. Alas, that's where we are right now.

However, before the General Counsel's policy change, guess which company was among DDMAC's chief culprits? You guessed it. Merck. In both Vioxx and Fosamax, DDMAC sent letter after letter to Merck warning Merck to quit misleading the American public. It should come as no surprise, then, that in August 2004, when the FDA requested Merck to warn consumers about the risk of osteonecrosis of the jaw and Fosamax use, Merck felt free to not follow the FDA's request, and still have not followed the FDA's request to this day.

If you're interested, here are the FDA's warning letters which were sent before the DDMAC warning letter program was severely curtailed by the FDA General Counsel.

http://www.fda.gov/cder/warn/apr97/fosamax.pdf
http://www.fda.gov/cder/warn/july97/fosamax.pdf

http://www.fda.gov/cder/warn/july99/8086.pdf

http://www.fda.gov/cder/warn/2001/9727.pdf

At Levin Papantonio, we represent no corporations, no big political donors. We represent individual American taxpayers who happen to have been harmed by corporate wrongdoings. We will continue in our efforts representing the injured victims of Fosamax.