The FDA is launching a new effort for post-approval drug safety, called "Safety First," meant to strengthen its supervision of prescription drugs after approval.
The plan, first reported by the Wall Street Journal and confirmed by FDA spokesman Christopher DiFrancesco, includes the creation of a new database of possible side effects from drugs, and to establish schedules for following up on safety concerns.
The FDA's plan is an effort to address criticism that the agency has been slow to respond to potential side effects that surface after a medicine reaches the market. A prime example would be Merck's arthritis pill Vioxx, which the company withdrew in 2004 after research found it doubled heart attack and stroke risk.
The new plan will help to empower the office that monitors post-approval drug safety. According to some critics, the office that grants approval to new drugs often overrules concerns from the safety office.
According to FDA Deputy Commissioner, Janet Woodcock, "The drug safety office will be playing an expanded role in the resolution of certain drug-related safety issues. The safety group will also take the lead on epidemiological studies and medication error prevention."
The FDA is expected to testify about the plan today at a congressional hearing.