Hill Briefing — Reforming the FDA: The Impact of Proposed Changes on Patients and Health Policy

 Hill Briefing 

Reforming the FDA:

The Impact of Proposed Changes on Patients and Health Policy

Thursday, June 12, 2014 at 10 a.m. at Dirksen room 430

You’re invited to a Hill Briefing to learn more about the research, physician, and patient perspectives on proposed legislation aimed at improving FDA policies for the approval of drugs and devices.   

Who

  •      Jerry Avorn, MD, Professor of Medicine at Harvard Medical School;
  •        Gregg Gonsalves, AIDS activist and co-director of the Yale Global Health, a joint program of Yale Law School and Yale School of Public Health;
  •         Diana Levine, patient whose case against Wyeth went to the Supreme Court and has implications for recently proposed changes in FDA regulatory policies of generic drugs.
  •         Kim Hudak, patient who participated in a study of a birth control device approved by the FDA.

When:  June 12, 2014 from 10 a.m. to 11 a.m. 

Where: 430 Dirksen Senate Office Building. 

RSVP:  Please RSVP to Paul Brown at PB@center4research.org or by calling 202-223-4000.

Additional information: While current law requires that medical products be proven safe and effective, there is growing interest in speeding patients’ access to drugs and devices. It started with the urgent need for effective treatment for AIDS decades ago, and expedited pathways are now used for a wide variety of medical products.  What are the likely risks and benefits for patients of several legislative efforts involving the FDA (or going around it)?

The National Center for Health Research is dedicated to improving the health and safety of adults and children by using research to develop more effective treatments and policies.