Wednesday, June 08, 2005

Can't Get Any Respect!

Back when COX-2's were under fire, representatives of the drug industry lamented that they "can't get any repsect." You might have remembered this bit from the Financial Times:
Pfizer's chief executive said advances in health care could be harmed if the pharmaceutical industry is "demonized." In an interview with the Financial Times, Henry McKinnell lamented the sinking standing of drug makers. "We cure heart attacks and strokes and cancer, but we can't get any respect,” he said.
The pharmaceutical industry is really in trouble -- and, by McKinnell's logic, our health will really be harmed -- if the industry cannot even get any respect from leading Republicans!

Take Senate Finance Committee Chair Chuck Grassley (R-Iowa) for example. He's been giving the industry a hard time and most recently has criticized the new drug safety board established by the Food and Drug Administration (see "
Drug Safety Panel Is Criticized").

Do you think the Drug Safety Oversight Board proposed by the FDA is independent enough and propoerly constituted with the right mix of experts? Please answer this and a few other questions in this month's Pharma Marketing News Drug Safety Survey.

Here's the letter the Senator wrote the FDA:
Dear Dr. Crawford:

On May 18, 2005, the Food and Drug Administration (FDA) announced the members of its new Drug Safety Oversight Board (DSB). According to the FDA's policies and procedures manual for the DSB, one of the purposes of this board is to provide independent oversight and advice to the director of the Center for Drug Evaluation and Research (CDER) regarding drug safety issues.

The new board, however, is established within CDER and has no authority to pull a drug from the market if it determines that the drug is harmful to patients. Of particular concern to me is the makeup of the DSB. The FDA states that the DSB will "enhance the independence of internal deliberations and decisions regarding risk/benefit analyses and consumer safety." But, I do not believe that this is the case for several reasons. First, a majority of the DSB members are senior managers within CDER, the center responsible for drug approvals. In fact, CDER officials hold 11 out of a total of 15 voting positions on the DSB. Even more interesting regarding the make-up of the board is the fact that only three of the 11 DSB CDER officials come from organizational subunits not directly involved in the review of new drug applications. Moreover, two of these three originally came from the Office of New Drugs, which is charged with getting new drugs on the market in the first place. So, what we have here is nothing more than the status quo. My question to you, Dr. Crawford, is: Where are the people responsible for post-marketing surveillance who have allegiances only to post-marketing safety and the public's well-being and not to the drugs that they helped put on the market in the first place?

In addition, according to FDA Week (May 20, 2005), the FDA announced in early May that the deliberations of the DSB will be private, unlike decisions that are made by FDA's advisory committees. It is surprising to me that the FDA has chosen to make DSB deliberations private at a time when the agency should be making every effort to improve transparency and accountability.

As Chairman of the Committee on Finance, I request that the FDA explain in detail how it will ensure that the DSB is truly independent and objective. In addition, please describe in detail any actions the FDA will take to assure the public that decisions made by the DSB will be unbiased.

I look forward to hearing from you regarding the issues and concerns set forth in this letter and would appreciate a response to my inquiries no later than July 1, 2005.


Charles E. Grassley
Grassley has introduced legislation that calls for an independent drug safety office:
An independent drug safety office would more effectively regulate drugs once they’re on the market. If you want accountability, it doesn’t make sense to have the office that reviews the safety of drugs to be under the thumb of the office that puts the drugs on the market in the first place. The drug safety office would have an independent director and the regulatory authority to require label changes. (See "INTRODUCTION OF AND REMARKS BY SEN. GRASSLEY BEFORE THE CONSUMER FEDERATION OF AMERICA ON THE FDA AND PRESCRIPTION DRUG SAFETY").
For more thoughts on the FDA and drug safety, see "Proposal for a Drug Risk Advisory System" and "FDA Drug Watch Site Guidelines").

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