November 30,2005

Grassley asks FDA to keep providing new information about erectile dysfunction drugs

WASHINGTON --- Sen. Chuck Grassley said the Food and Drug Administration has taken important steps to better inform consumers about the risk of vision loss from prescription medicines that treat erectile dysfunction and urged the agency to be more proactive in communicating with doctors and patients should additional concerns be identified.

Grassley's letter to the Acting Commissioner of the FDA addresses an October 20response to him from the drug safety agency. A copy of the FDA's letter is posted with thisnews release at http://finance.senate.gov.

Last summer, Grassley was outspoken about the need for the FDA to provide more timely information in a user-friendly format regarding new findings that erectile dysfunction drugs could cause serious damage to eyesight. Copies of Grassley's August 24 and June 24 letters are also posted at http://finance.senate.gov, along with this news release.

Grassley is Chairman of the Senate Committee on Finance and has conducted oversightof the FDA. He has also introduced bipartisan legislation to mandate a clinical trials registry fordrug makers (S.470) and to establish independence within the FDA for the office that reviewsFDA-approved drugs after they're on the market (S.930).

Grassley has said that the FDA must both make available to consumers new life-saving and life-enhancing medicines as quickly as possible and be diligent in considering any newdrug-safety risks that may become apparent after drugs are in the marketplace. "A commitment to transparency and letting the science prevail are the keys to the FDA's success as the world's premiere drug-safety agency," Grassley said.

Here is the text of the recent letter Grassley sent to the FDA.

November 22, 2005

Andrew C. von Eschenbach, M.D.
Acting Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Dr. von Eschenbach:

Thank you for the Food and Drug Administration's (FDA) response to my letter datedAugust 24, 2005, requesting that the FDA describe actions that will be taken to ensure thatpatients and consumers are informed of the risks of permanent vision loss associated with the useof drugs prescribed by physicians to treat erectile dysfunction (ED).

I commend the FDA on its efforts to inform patients and consumers about the safetyconcerns regarding ED drugs. The FDA's letter, dated October 20, 2005, outlined a number ofactions taken by the agency to date to communicate ED drug safety information to patients andtheir health care providers, including revising patient package inserts, partnering with groups,such as Medscape, to expand the agency's ability to disseminate safety information, andproviding information to local and national media outlets and through the FDA's own PatientSafety News program and website. In addition, I applaud the FDA's initiative to improve its riskcommunication to ensure that patients and physicians have the most up-to-date and completeinformation about FDA-approved drugs on the market. However, I am also interested inknowing what action, if any, the FDA has taken to date to ensure that future safety concernsregarding ED drugs are detected and disclosed in a timely manner, including but not limited toimplementing risk management plans with ED drug manufacturers to track adverse events and toconduct additional post-market safety studies.

In closing, I hope that, in the future, the FDA will take a similar approach to educating thepublic of new safety concerns associated with the drugs as well as medical devices and otherproducts that are regulated by the FDA. Accordingly, as Chairman of the Committee on Finance,I request that the FDA describe in detail how the agency plans to maintain the riskcommunication activities and programs outlined in its October 20, 2005 letter. In addition,please describe any efforts to apply the agency's drug safety communication strategies to otherareas under the FDA's jurisdiction. Finally, state whether or not the FDA has implemented orwill implement risk management plans for ED drugs. If so, describe in detail what the riskmanagement plan entails.

Thank you for your attention to this important matter. Please provide the requestedinformation by no later than December 8, 2005.

Sincerely,

Charles E. Grassley
United States Senator
Chairman, Committee on Finance