Dear Dr. Crawford:
On May 18, 2005, the Food and Drug Administration (FDA) announced the members ofits new Drug Safety Oversight Board (DSB). According to the FDA's policies and proceduresmanual for the DSB, one of the purposes of this board is to provide independent oversight andadvice to the director of the Center for Drug Evaluation and Research (CDER) regarding drugsafety issues.
The new board, however, is established within CDER and has no authority to pull a drugfrom the market if it determines that the drug is harmful to patients. Of particular concern to meis the makeup of the DSB. The FDA states that the DSB will "enhance the independence ofinternal deliberations and decisions regarding risk/benefit analyses and consumer safety." But, Ido not believe that this is the case for several reasons. First, a majority of the DSB members aresenior managers within CDER, the center responsible for drug approvals. In fact, CDER officialshold 11 out of a total of 15 voting positions on the DSB. Even more interesting regarding themake-up of the board is the fact that only three of the 11 DSB CDER officials come fromorganizational 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 gettingnew drugs on the market in the first place. So, what we have here is nothing more than the statusquo. My question to you, Dr. Crawford, is: Where are the people responsible for post-marketingsurveillance who have allegiances only to post-marketing safety and the public's well-being andnot 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 Maythat the deliberations of the DSB will be private, unlike decisions that are made by FDA'sadvisory committees. It is surprising to me that the FDA has chosen to make DSB deliberationsprivate at a time when the agency should be making every effort to improve transparency andaccountability.
As Chairman of the Committee on Finance, I request that the FDA explain in detail howit will ensure that the DSB is truly independent and objective. In addition, please describe indetail any actions the FDA will take to assure the public that decisions made by the DSB will beunbiased.
I look forward to hearing from you regarding the issues and concerns set forth in thisletter and would appreciate a response to my inquiries no later than July 1, 2005.
Sincerely,
Charles E. Grassley Chairman
Source: Ranking Member’s News
