Hearing Examines Safe and Affordable Generic Biotech Drugs

On Monday, March 26, the Oversight Committee held a hearing to examine the high cost of biotech medicines to our health care system, as well the prospects and need for a pathway that would allow the FDA to approve safe and affordable generic versions of biotech drugs. Witnesses included representatives of FDA, pharmaceutical manufacturers, scientists, and consumer groups. A preliminary transcript of this hearing is now available.

The following witnesses testified:

Panel I:

• Dr. Janet Woodcock, M.D., Food and Drug Administration

Panel II:

• Ganesh Venkataraman, Ph.D., Research Momenta Pharmaceuticals, Inc.


• Geoffrey Allan, Ph.D., Insmed Incorporated


• Bill Schwieterman, M.D., Tekgenics Corporation (formerly with FDA’s Center for Biologics)


• Theresa Lee Gerrard, Ph.D., TLG Consulting, Inc. (formerly with Amgen and FDA’s Center for Biologics)


• Inger Mollerup, Novo Nordisk A/S

Panel III:

• Nelda Barnett, AARP


• Scott D. McKibbin, State of Illinois


• Mary Nathan, National Organization for Rare Disorders (NORD)


• Yvonne Brown, National Multiple Sclerosis Society


• Jonah Houts, Express Scripts, Inc.


• Priya Mathur, California Public Employees' Retirement System (CalPERS)


• Henry Grabowski, Ph.D., Duke University