June 08,2005

Grassley Continues Push for Transparency, Accountability and Independence at FDA

WASHINGTON — Sen. Chuck Grassley is questioning the make-up of the new drug and safety board set up by the Food and Drug Administration to provide independent review of FDA approved medicines.

In a letter sent to the acting commissioner of the nation’s drug safety agency, Grassleyasked for assurances that the board could act in an unbiased way given its composition and saidthe deliberations of the panel should be more transparent in order to improve accountability at the Food and Drug Administration.

Grassley has conducted oversight of the Food and Drug Administration since early lastyear based on concerns about how the agency resisted making public information about suiciderisks for teenagers using antidepressants and cardiovascular risks associated with the painkillerVioxx. Grassley is chairman of the Senate Committee on Finance, which is oversees theMedicare and Medicaid programs. Medicaid has spent more than $1 billion on Vioxx. Medicarewill offer a new prescription drug benefit beginning in January. Grassley has advocatedadministrative and legislative reforms to make the Food and Drug Administration's work moretransparent.

In April, Grassley and Sen. Christopher Dodd introduce a bill (S.930) to set up an new,independent Center inside the Food and Drug Administration to review drugs and biologicalproducts once they are on the market. In February, Dodd and Dodd and Grassley introduced aseparate bill (S.470) to make clinical trial results publicly available to researchers, doctors and consumers. Both pieces of legislation have been endorsed by consumer and health groups including the Center for Medical Consumers, the Consumer Federation of America, Consumers Union, the National Women's Health Network, Public Citizen, and the U.S. Public Interest Research Group.

The text of Grassley’s letter regarding the FDA’s new Drug Safety Oversight Boardfollows here.

June 6, 2005

Lester M. Crawford, D.V.M., Ph.D.
Acting Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

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.


Charles E. Grassley