Medical Community Reacts To Obama And Congressional Plans To Approve Generic Forms Of Biologic Medicines

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Conferences
Article Date: 17 Apr 2009 - 4:00 PDT

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The Obama administration's goal of expanding the availability of generic forms of biologic drugs - and a variety of congressional efforts to fulfill the administration's goal - will be discussed on April 21st at the National Press Club in Washington, DC when the Jefferson School of Population Health hosts a forum on the quality and safety issues surrounding the creation of a regulatory pathway for follow-on biologic drugs. Attendees will also offer recommendations and key take-away messages for policy makers on Capitol Hill and in the administration.

The outcome of this debate is likely to have far-reaching implications with regard to access, cost, safety, and therapeutic impact for thousands of patients with serious, life-threatening, and chronic diseases. For this reason, it is critical that decision makers hear from all key stakeholders who have information and insights on the various touch points of this important health care issue before reaching a conclusion.

Many important factors must be taken into consideration when developing an appropriate process to review, assess, approve, and regulate the use of follow-on biologics and other related complex molecules:

-- How to protect patient safety;

-- What level of evidence should be required for consideration of use of a follow-on product;

-- What factors should be considered when creating guidelines around interchangeability;

-- How will post-marketing surveillance be conducted for these new products to monitor for adverse events;

-- How will we determine efficacy; and

-- What are the ethical considerations when conducting a cost-benefit analysis?

The April 21st event will be held at the National Press Club, Holeman Lounge, 529 14th Street, N.W., Washington, DC. The featured speakers at the event will be:

-- David B. Nash, MD, MBA, Dean, Jefferson School of Population Health

-- Geno Merli, MD, Professor of Medicine, Jefferson Medical College, Senior Vice President and Chief Medical Officer, Thomas Jefferson University Hospital

-- Michael McCaughan, Editor-in-Chief, The Pink Sheet, FDC/Windhover Biopharma Group

-- Ann Witt, JD, Health Counsel to U.S. Congressman Henry Waxman

Also speaking will be:

-- Brian Harvey, MD, PhD, Vice President Regulatory Policy, sanofi-aventis

-- R. Terry Hisey, Vice Chairman, U.S. Life Sciences Leader, Deloitte LLP

-- Judith Jones, MD, PhD, President & CEO, Degge Group, Ltd.

-- Laurence Kotlikoff, PhD, Professor of Economics, Boston University

-- Gundu H. R. Rao, PhD, Professor, Laboratory Medicine and Pathology, Lillehei Heart Institute, Institute for Engineering Medicine, University of Minnesota

-- Randy Vogenberg, RPh, PhD, Chief Strategic Officer, EPS LLC, Executive Director, Biologic Finance and Access Council

Source: Jefferson School of Population Health

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