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.

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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.

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Introducing the FDA/CMS Summit for Biopharmaceutical Executives

Join us for the 10th Annual FDA-CMS Summit, for biopharmaceutical executives, December 11-12, 2014 in Washington, DC. Our keynote speakers and panels will take a deep dive into each of these topics, and more. You'll leave better able to make strategic decisions on issues such as:

• The commercial outlook for biopharma under the new health care exchanges

• Updates on the latest drug review statistics from the Office of New Drugs and industry's experience under the new review "Program"

• The future of drug safety at FDA - both for the increasingly popular rare disease drugs as well as new treatments for large primary care markets like obesity and diabetes

• What's in store for the reauthorization of PDUVA VI, and a preview of what's to come as industry and FDA take a second look at BsUFA and GDUFA.

• Coming changes to Medicare Part D and what CMS has in store for the prescription drug benefit

• What the mid-term Congressional elections will mean for the biopharma industry.

 
Speakers Include:

o Janet Woodcock, MD, Director, Center for Drug Evaluation and Research (CDER) Food and Drug Administration (FDA)
o John Jenkins, MD, Director, Office of New Drugs, Food and Drug Administration (FDA)
o Leah Christl, Associate Director, Biosimilars Program, Office of New Drugs Food and Drug Administration (FDA)    
o Gerald Dal Pan, MD, Director, Office of Surveillance & Epidemiology, Food and Drug Administration (FDA)
o Jim Robinson, President, Astellas Pharma US    
o Sumant Ramachandra, MD, PhD, MBA, SVP & Chief Scientific Officer, Hospira
o Robert Clark, VP, US Regulatory Affairs, Novo Nordisk    
o Francois Nader, MD, CEO, NPS Pharmaceuticals
o Karen Jones, VP, Global Head of Oncology Regulatory, Genentech    
o Chris Garabedian, CEO, Sarepta
o David Beier, Partner, Bay City Capital    
o John McHutchison, MD, Executive Vice President, Clinical Research, Gilead
o Mark McClellan, MD, PhD, Senior Fellow and Director, Health Care Innovation and Value Initiative, Brookings Institution    
o Niall Brennan , Acting Director, Office of Enterprise Management, Centers for Medicare & Medicaid Services (CMS)
o Tamara Syrek Jensen, JD , Deputy Director, Coverage and Analysis Group, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services (CMS)    
o Mark McCamish, MD, PhD, Global Head Biopharm.& Oncology Injectables Development, Sandoz International GmbH
o Karen Jones, VP, Global Head of Oncology Regulatory, Genentech    
o Chris Garabedian, CEO, Sarepta
o David Mott, General Partner, Biopharmaceutical Investments, New Enterprise Associates (NEA), Former CEO, MedImmune    
o Steven Nissen, MD, MACC, Chairman, Department of Cardiovascular Medicine, The Cleveland Clinic Foundation

Register now for this can't-miss event! 

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Woodcock reports release of biosimilars is imminent

While the release of guidance for biosimilars have been long awaited by the Pharmaceutical industry, Janet Woodcock has stated it could come as early as next week, but definitely before the end of the year.  Reuters reports that Pharma representatives and the FDA have come to an agreement on how fees would be collected to support the biosimilars process and a pathway.  While biosimilars are a generic version of biologics, which are used to treat such diseases as diabetes and multiple sclerosis.

What do you anticipate to see from the long-awaited biosimilars draft guidance?

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