"Don't Be Afraid of Drug Safety Reform," Say Regulators, Industry Experts at Pharma Executive Summit.

Windhover's FDA/CMS Summit Features Keynote Addresses and Panel Discussions on Key Topics for Pharmaceutical Industry Executives

WASHINGTON -- Dr. Stephen Galson, Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration, led a slate of keynote speakers and panelists from industry, regulatory agencies and academia at Windhover's 2nd Annual FDA/CMS Summit today. Across the presentations was a common resonating theme of imminent drug safety reform. However, rather than being seen as an obstacle to business, industry executives and regulators suggest the coming discussion presents an opportunity to define a new model of drug development and evaluation for the 21st century.

Executives from MedImmune, Merck and Roche posited that developments in personalized medicine and a focus on value-based healthcare offer a business opportunity on which companies may capitalize. To understand the implications of potential changes to drug safety evaluation, as well as other hot topics, the audience of more than 200 heard from:

* Andrew von Eschenbach, MD, Acting Commissioner, FDA 

* Mark McClellan, MD, PhD, Former Commissioner, FDA and Former Administrator, CMS 

* Janet Woodcock, MD, Deputy Commissioner for Operations, FDA

* Stephen Northrup, Health policy director for the Senate Health, Education, Labor and Pensions (HELP) Committee

* Rachel Sher, Health counsel to Rep. Henry Waxman (D-CA)

"For industry, the year ahead will almost certainly bring about changes in drug safety evaluation and reporting," said Michael McCaughan, Senior Editor of Windhover's The RPM Report. "The FDA/CMS Summit provides an unparalleled 'sneak preview' directly from the policy-makers themselves as pharmaceutical executives seek to navigate the political, regulatory and business landscape."

There was also general agreement among speakers and panelists that the FDA will require additional resources to implement any potential expansion of drug safety oversight. The coming year will see reauthorization of the Prescription Drug User Fee Act (PDUFA), as well as other key funding vehicles for the agency. Whatever changes are made, it is clear that they will require additional resources to carry out, either in the form of appropriations or industry user fees. Panelists from industry and the FDA agreed that striking a balance between government and industry contributions is key to a reasonable agreement.

Windhover's FDA/CMS Summit is the premier annual event designed to cut through the jargon and rhetoric to provide executives with practical insight as well as an insider's view on critical regulatory and policy issues.

Day two of the summit will continue the dialogue around drug safety, as well as include insight from panelists on topics ranging from follow-on biologics to price negotiation. Speakers and panelists are scheduled to include:

* Scott Gottlieb, MD, FDA

* Larry Kocot, CMS

* Steven Nissen, MD, The Cleveland Clinic Foundation

* Jayson Slotnik, Biotechnology Industry Organization (BIO)

* Kathleen Jaeger, Generic Pharmaceutical Association (GPhA)

A complete agenda is available online at www.windhover.com/fda-cms.

Sponsors of this year's summit are The RPM Report, Foley Hoag LLP, Ogilvy Public Relations Worldwide, the Personalized Medicine Coalition and Health Hombre.

About The RPM Report

The RPM Report is a unique Windhover publication that examines FDA and CMS from a business perspective, designed to deliver not only the news from FDA and CMS but to tell executives what it all means to their companies. The RPM Report is written for the biopharma CEO, business development director, R&D chief, marketer, reimbursement manager, or public affairs specialist.

About Windhover Information, Inc.

Windhover Information Inc. has led the field in providing analysis of the healthcare industry to decision-makers at all levels since the founding of its flagship publication, IN VIVO, The Business & Medicine Report, in 1983. Windhover provides its information and analysis in many formats, including print, electronic databases, international conferences and audio conferences. For more on the company's products and services, please see www.windhover.com.