A customer leans against a pharmacy counter in a file photo. The FDA is launching a new effort meant to strengthen its oversight of prescription drugs after they win approval, an agency official said on Tuesday. REUTERS/Jessica Rinaldi  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.
FDA plans new post-approval drug safety effort.