May 16,2007

Grassley seeks to empower FDA to access drug-risk information from drug makers

WASHINGTON — Sen. Chuck Grassley wants to make sure drug makers fully disclose data from their drug studies to the Food and Drug Administration, and he’s asking the drug-safety agency if it needs new power to collect such information and a major drug maker to account for how it handled requests from the FDA for information about anti-anemia drugs given to kidney and cancer patients.

In letters sent this week, Grassley has asked the FDA to identify any new tools it might need to gain access to necessary information from drug makers. He also has asked Amgen to respond to allegations that it limited FDA access to the results of company studies and did not provide complete responses to the agency’s requests for data.

“The Senate has already passed its FDA revitalization legislation, but the House of Representatives hasn’t acted yet, so there’s still time for congressional leaders to consider new and important measures to strengthen the hand of the FDA in looking out for American consumers,” Grassley said. “There could be important lessons to learn from this particular case, and since Congress doesn’t act very often on FDA legislation, so we ought to focus on what happened in a very time-sensitive way.”

Amgen is the maker of erythropoisesis-stimulating agents, which are used for the treatment of anemia in patients with chronic kidney failure as well as chemotherapy-induced anemia. Last week an FDA advisory panel recommended that more information should be provided about the risks of these drugs and new studies should be conducted to assess the drugs’ safety. In addition, news organizations reported assertions that Amgen had not provided study data to the FDA upon request and had not been up front about safety risks.

Last month, Grassley asked the Centers for Medicare and Medicaid Services to address reimbursement and drug safety concerns related to the use of these anti-anemia drugs. Grassley said he has received a preliminary response to this inquiry and will continue to pursue a payment policy that guards both tax dollars and patient safety.

The text of Grassley’s letters to the FDA, Amgen and CMS follows here.