Woodcock: Hill should hold line on standards

Share this article:
Janet Woodcock
Janet Woodcock

FDA drugs director Janet Woodcock told the House Energy and Commerce Committee in March that Congress should not change the standards for determining a therapy's safety and effectiveness under proposed changes to the agency's accelerated approval pathway that are being considered as part of the reauthorization of prescription drug user fees.

To expand the accelerated approval program, she said the agency plans “to issue guidance to clarify use of accelerated approval and explain our evidence standards more clearly.”

Asked by subcommittee chairman Joe Pitts (R-PA) about whether FDA means to limit accelerated approval for cancer drugs, Woodcock said no. “Over the last year we have approved cancer drugs using accelerated approval… So we are not really backing away.”

Representing Biotechnology Industry Organization, Alnylam Pharmaceuticals CEO John Maraganore testified in support of a bill introduced by Rep. Cliff Stearns (R-FL) and Rep. Ed Towns (D-NY) that aims to streamline and modernize FDA's accelerated approval pathway.
Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

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?