Wednesday, November 19, 2014

Creating A New FDA/Capitol Hill Legend

Via RPM Report, an FDA/CMS Summit for Biopharma Executives event supporter. The RPM Report provides actionable insight on regulation, policy, FDA and CMS to apply directly to your decision-making.

When FDA managers reflect on their experiences on Capitol Hill, the stories often involve unfair, inflammatory or downright abusive sessions. But Center for Drug Evaluation & Research Director Janet Woodcock has built a different legend this year during the 21st Century Cures initiative of the House Energy & Commerce Committee.

CDER Director, Janet Woodcock has pulled off a Capitol Hill miracle during the 21st Century Cures review of the issues affecting drug and medical device development and commercialization, being the regulator embraced by both sides of the aisle.

From start to finish, Woodcock has basked in praise from Republicans and Democrats. But those notes of praise rose to a crescendo during the final, pre-election session hosted by the E&C/Health Subcommittee on Friday, Sept. 19. During a hearing focused on antibiotic development incentives, Woodcock engaged in a cordial farewell dialogue with the soon-to-retire Rep. Waxman (one of Democrats who traditionally has not been among her supporters), diplomatically handled more calls for FDA-based incentives for the development of antimicrobials and other drugs, and then received congratulations from Rep. John Shimkus (R-Ill.) who applauded Woodcock for staying to listen to the second panel of the hearing.

Incentives Entail Congressional Art, Not Opinions of FDA Scientist/Doctor

Based on her performances, Woodcock has earned the ability to defer opinions on flashpoint issues without looking like she was dodging the issue.

On the topic of incentives for drug developers based on FDA or by conferring exclusivity to a target category or to another drug chosen by the sponsor, Woodcock was able to avoid staking out a stance one way or the other, and instead referred to the criticisms of incentives raised by Waxman and noted that striking that type of balance falls in the realm of Congress and politics and to a physician and scientist.

She had few failures over the five-month period and none that seem to do damage to the agency’s improving reception on Capitol Hill.

Woodcock has so far been unable to see her idea of pushing improvement in drug quality and manufacturing as a jobs issue and a way to stimulate the US economy. That’s a big issue to Woodcock but a small down-note in an otherwise harmonious legislative season for the agency.


Do you want the chance to hear from Janet Woodcock, other key regulators from the FDA and CMS, and industry game changers? Join them at the 10th Annual FDA/CMS Summit for Biopharma Executives this December 11-12, in Washington D.C.

At the event, Janet Woodcock will be addressing what the midterm congressional elections mean for the biopharma industry. Do not miss this!

Register here.

Share this article with your social network, just click below to share now!

No comments :

Post a Comment