FDA offers safety reforms to skeptical lawmakers

The FDA has outlined new steps aimed at improving the way new drugs are monitored following approval. In response to a highly critical report from the Institute of Medicine, the FDA will begin to issue report cards 12 to 18 months after approval to highlight any safety problems that could come to light. Those report cards would include the results of follow-up studies. The agency also said it was taking steps to change the agency's culture and improve communications so that safety experts wouldn't feel shut out. The FDA is reaching out to CMS, the VA and insurers to gather more data on problems linked to drugs. And the agency is promising greater transparency in its choice of experts for the highly influential panels that often decide the fate of an experimental medicine.

Over the years the FDA has been held up to harsh criticism that it is too close to drug companies and is too focused on the approval process while ignoring the safety issues that arise after a drug is OK'd for marketing. A member of the IOM panel, R. Alta Charo (photo), told the Washington Post that the FDA had taken steps in the right direction, but that drug safety experts still didn't have the clout they needed. And members of Congress quickly swooped on FDA Commissioner Andrew von Eschenbach (photo), saying that the agency had far more work to do and offering new bills to force developers to publicly reveal all trial data.

- check out the FDA's release
- here's the article from The New York Times

Suggested Articles

Solid Bio fixed the manufacturing issue that led to a partial clinical hold on its DMD trial, but a full hold remains.

Commissioner Scott Gottlieb has laid out the reasons why he thinks the FDA needs a double-digit budget bump.

GW's cannabis-based epilepsy drug scored a favorable review from FDA staff ahead of an expert panel meeting.