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:
You must be a registered member of MMM to post a comment.

Next Article in Features

Email Newsletters


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Features

Read the complete September 2014 Digital Edition

Read the complete September 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.

Medical marketing needs mainstream Mad Men

Medical marketing needs mainstream Mad Men

Agencies must generate emotional resonance with the target audience, not unlike Apple, Pepsi or Nike

Are discounts cutting out co-pays?

GSK's decision to cut Advair's price spurred some PBMs to put it back on formulary. Will drugmaker discounts diminish the need for loyalty programs? How can these programs stay relevant beyond giving co-pay assistance?