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This Week: Congressional Briefing and Public Meeting on Fate of FDA Generic Labeling Rule

March 24, 2015


This Week: Congressional Briefing and Public Meeting on Fate of FDA Generic Labeling Rule

Public Citizen Urges Agency to Resist Industry Pressure, Protect Patients

WHAT: Congressional briefing and public hearing regarding the fate of the U.S. Food and Drug Administration’s (FDA) proposed rule to enable generic drug makers to update warning labels when they learn of new dangers. Dr. Michael Carome, director of Public Citizen’s Health Research Group, will participate in both events and urge the agency to resist pressure from the pharmaceutical industry to put profits above patient safety.

The events come as the pharmaceutical industry is pressuring the FDA to weaken an essential patient safety rule.

The FDA’s proposed rule – issued in November 2013 in response to a Public Citizen petition (PDF) – would give generics manufacturers the ability to update labeling regarding newly discovered risks without obtaining prior approval from the FDA – much as brand-name manufacturers have been able to do for nearly 30 years. Under current rules, generic manufacturers are not permitted to update warnings to reflect new safety information unless instructed to do so by the FDA.

The proposed rule would protect patients by ensuring they have updated safety information as soon as possible, but the generics industry has been lobbying aggressively against the rule, arguing that it would raise generic prices.

Although the comment period on the proposed rule originally closed on March 13, 2014, the FDA has taken the unusual step of soliciting additional comments and holding Friday’s public hearing on an industry counterproposal.

At the events, experts will discuss the FDA’s proposal, an alternative industry proposal, the true cost of the regulation and the effects on consumers when generic labels cannot be updated in a timely fashion.

WHEN: Congressional briefing: 4:30–5:30 p.m., Thursday, March 26
FDA public meeting: 8 a.m.?5 p.m., Friday, March 27

WHERE: Congressional briefing: Rayburn House Office Building, Room 2103 (Independence Ave. SW and First St. SW), Washington, D.C.
FDA public meeting: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (room 1503), Silver Spring, Md.

WHO (congressional briefing): Host: U.S. Rep. Gwen Moore (D-Wis.)
Moderator: Cynthia Pearson, executive director, National Women’s Health Network
Dr. Michael Carome, director, Public Citizen’s Health Research Group
Dr. Frank Ackerman, senior economist, Massachusetts Institute of Technology and Synapse Energy
Tammy Gilbert, patient care assistant

Other participating groups at the congressional briefing include the National Center for Health Research, National Women’s Health Network and American Association for Justice.