The FDA’s director of drug evaluation and research, Janet Woodcock, denied in October that an increased focus on drug safety in recent years, fueled by public and congressional criticism of the agency’s safety oversight, has made her Center more “conservative.”
Addressing a Drug Information Association conference, she explained that if the regulatory process involves more technical hurdles than before, this is due to advances in science. “Agency reviews have always relied upon ‘all tests applicable,’” she said. “As the science advances, more tests become available—and more are applicable.”
In response to critics, the agency has moved forward in a number of areas to enhance drug safety, Woodcock said. Among these, she said the Center for Drug Evaluation and Research has issued 21 letters directing drugs/biologics sponsors to conduct clinical studies addressing safety issues; 24 sponsors have been notified that continued marketing of their products requires that they be accompanied by REMS; and four label changes reflecting appropriate warnings were made.