Monday, May 12, 2008

Janet Woodcock’s To Do List For CDER

Given that Janet Woodcock has been back at the Center for Drug Evaluation & Research for six months now (with two months as permanent director), we figured it was high time to check in and see what she’s been up to.

The answer? Quite a bit.

As Woodcock told The RPM Report in an interview, she's the kind of person that likes to get things done. So upon returning to CDER last October, Woodcock settled on two immediate objectives:

(1) Gaining direct hire procedures from HHS’ Office of Personnel Management.

(2) Dedicating more attention on post-marketing safety.

Check and check.

As a result of Woodcock’s efforts, FDA just won direct-hiring procedures from HHS and has since embarked on a major hiring initiative to staff up its scientific ranks. CDER alone will hire 663 employees—444 new positions and 219 in backfill. The hiring frenzy will eventually help end the “lean years” at FDA, when the agency's regulatory mandate outstripped its available resources.

On post-marketing safety, Woodcock launched the “Safety First” initiative last October, putting post-marketing drug safety on par with new drug approvals. As part of that multidisciplinary, team-based approach, the Office of Surveillance & Epidemiology is now an “equal partner” with the Office of New Drugs. Remember those public fights over Avandia and Ketek? Woodcock hopes that "Safety First" will put those to rest.

Of course, there are still challenges ahead. CDER needs to train all those new hires, and the Center is still feeling its way on the “Safety First” initiative and implementation of the FDA Amendments Act in general.

And then there’s the issue of those new risk evaluation and mitigation strategies, or REMS, which have Woodcock weighing in on new drug applications more than usual. For more on that, as well as the status of drug approvals under her stewardship, click here. If you're not already a subscriber to The RPM Report, you can sign up for a free trial to view the article.


Anonymous said...

The link to the drug approvals under Janet is not live.

Kate Rawson said...

Thanks for the catch -- it's live now.