Ropes & Gray Partner Discusses Challenges Posed by FDA Amendments Act
Ropes & Gray partner Greg Levine moderated the fourth webinar in a series on the issues and implementation of the Food and Drug Administration Amendments Act. The webinar attracted participation from regulatory affairs, legal, medical affairs and management team members in the drugs and biologics industries.
Levine moderated, "The Reauthorization of FDA’s Prescription Drug User Fee Program and the Agency’s Use of Risk Evaluation and Mitigation Strategies (REMS)," a panel of health care executives discussing challenges relating to FDA's implementation of Risk Evaluation and Mitigation Strategies (REMS) and mandatory safety-related labeling change authorities for drug and biological products under the Food and Drug Administration Amendments Act (FDAAA).
“FDAAA mandated a process that the Food and Drug Administration must follow for receiving input on and conducting negotiations over the next reauthorization of the Prescription Drug User Fee Act in 2012 (PDUFA V),” said Levine, a Washington, D.C.-based partner who focuses on FDA regulation of pharmaceuticals, biotechnology, medical devices and cosmetics. “Pharmaceutical and biologics manufacturers, as well as other stakeholders, are obviously concerned about striking the right balance between assuring the safety and efficacy of new treatments and avoiding unnecessary delays in bringing those improved treatments to patients. As FDA re-evaluates the prescription drug user fee program, it is vital that regulated industry as well as other interested parties understand the status and remaining steps in the PDUFA V reauthorization process and the substantive issues likely to be at the center of the PDUFA V debate.”
The panelists included Mitchell S.Y. Cohen, senior counsel in the legal department of Kaiser Foundation Health Plan, Inc. and Kaiser Foundation Hospitals; Marc M. Boutin, executive vice president and chief operating officer of the National Health Council, and Jeffrey K. Francer, assistant general counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA).
The webinar addressed the status and remaining steps in the PDUFA V reauthorization process, the substantive issues likely to be at the center of the PDUFA V debate, and the status of FDA's implementation of the FDAAA.