FDA Could Allow Generic Drugmakers To Update Safety Labels

redOrbit Staff & Wire Reports – Your Universe Online

The US Food and Drug Administration (FDA) could soon allow generic drug manufacturers to change safety labels on their medications to reflect updated safety information.

The agency announced the proposed new rule on Wednesday, and according to Katie Thomas of the New York Times, it could open the door for these pharmaceutical companies to be targeted by lawsuits for the first time since such actions were prohibited by the US Supreme Court two years ago.

“Consumer advocates applauded the development, calling it a necessary fix for a system that they say is unfair to patients who take generic medicines,” Thomas reported.

Likewise, Dr. Sidney M. Wolfe, a senior adviser to the Health Research Group at Public Citizen told the Times the rule changes were “common sense” and would allow individuals who were physically harmed by generic drugs to go to “court and get redress for serious damages.”

Under the current system, manufacturers of generic medications are prohibited from updating the safety information on their drug labels, even if they discover a potential issue that is not included on the existing one, according to a Reuters report. The new FDA proposal, however, would allow such changes to be made, and would require all manufacturers of a given drug to carry uniform warnings if the agency approved a revision issued by any one of them.

“It is a first step toward acknowledging that there is a problem with the current system,” attorney Michael Johnson, representing one of the patients who sued generic drug companies in the 2011 Supreme Court case, told Thomas. “It doesn’t make sense to have one set of rules for the name brand and another set of rules for the generics.”

Ralph Neas, president of the Generic Pharmaceutical Association, disagrees, telling Aubrey Pringle of Medill News Service, “Decisions on safety and efficacy of prescription drugs should rest in the hands of the FDA, the only body with the scientific knowledge, regulatory experience and complete data that is needed to make these decisions.”

The FDA told Pringle the rule changes would make generic and brand-name drugmakers equal when it came to updating warning labels. The notice was posted Wednesday on the Office of Management and Budget website, Thomas said, and indicates the FDA intends to publish a proposed rule by September. A period of public comment would begin shortly thereafter, she added.