Dear Dr. von Eschenbach:
Thank you for the Food and Drug Administration's (FDA) response to my letter datedAug. 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 Oct. 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 Oct. 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
Source: Ranking Member’s News
