Saturday, March 28, 2015

Generics rule: Public Citizen Urges FDA to Resist Industry Pressure, Protect Patients

As the FDA wobbles under industry pressure and reopens the comment period on the rule that demands generic drug manufacturers warn of safety risks as soon as they learn of them, Public Citizen which petitioned for the rule change spoke at the hearing on March 26, 2015. - gwc

Public Citizen Press Room

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.
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