FDA plans new post-approval drug safety effort
WASHINGTON (Reuters) - The U.S. Food and Drug Administration is launching a new effort meant to strengthen its oversight of prescription drugs after they win approval, an agency official said on Tuesday.
The plan, called "Safety First," includes creation of a new database of possible side effects from medicines, plus clear schedules for following up on concerns about them.
The effort was first reported by the Wall Street Journal. FDA spokesman Christopher DiFrancesco confirmed the information in the Journal's story.
The action is the FDA's latest move to address charges that the agency has been slow to respond to potential side effects that emerge after a medicine reaches the market.
The agency was sharply criticized for its handling of Merck & Co Inc's arthritis pill Vioxx, which the company withdrew in 2004 after research found it doubled heart attack and stroke risk.
The new plan will grant some new powers to the office that monitors the safety of medicines after their approval. Critics have said concerns from the safety office frequently get overruled by the office that grants approval to new drugs.
The pre-market review office may have a bias in favor of a medicine it previously deemed safe enough to be sold, critics say.
The drug safety office "will be playing an expanded role in the resolution of certain drug-related safety issues," FDA Deputy Commissioner Janet Woodcock wrote in an e-mail to staff that was provided to Reuters.
The safety group also will take the lead on epidemiological studies and medication error prevention, Woodcock said.
But the effort will not give the post-approval safety office ultimate power to sign off on new warnings or recommendations to remove a drug from the market, the Wall Street Journal said.
FDA Commissioner Andrew von Eschenbach told the Journal the agency was creating a new appeals process for cases of scientific disagreement that can take a dispute up to the office of the commissioner.
The FDA is expected to testify about the plan at a congressional hearing on Wednesday.
(Reporting by Lisa Richwine; Editing by Tim Dobbyn)
