Rx safety hasn't made agency 'conservative'

Share this article:
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. 
Share this article:
close

Next Article in Features

Email Newsletters

More in Features

Leadership Exchange: How Do We Get Beyond the Pill?

Leadership Exchange: How Do We Get Beyond the ...

As its focus moves from manufacturing to service, pharma needs to partner with healthcare neophytes as well as established players. James Chase asks six experts to assess the risks and ...

FDA and off-label uses: a balancing act

FDA and off-label uses: a balancing act

FDA's current re-examination of its off-label promotion policies in light of the First Amendment is a delicate balancing act between its rock-solid traditional enforcement posture and a diverse new electronic ...

Read the complete August 2014 Digital Edition

Read the complete August 2014 Digital Edition

Click the above link to access the complete Digital Edition of the August 2014 issue of MM&M, with all text, charts and pictures.