US Congressmen express concerns on FDA's proposed change to generic drug labeling policy

US Senator Lamar Alexander (Republican, Tennessee), the senior Republican on the Senate Health Committee, is leading a group of Senate and House Republican lawmakers in sending a letter to Food and Drug Administration Commissioner Margaret Hamburg expressing concerns about the FDA’s proposed regulation to allow generic drug companies to unilaterally change their drug labeling information, saying “such a rule would conflict directly with the statute, thwart the law’s purposes and objectives, and impose significant costs on the drug industry and healthcare consumers.”

The letter says: “We are writing to express grave concerns regarding a regulation…that would change longstanding policy regarding the 1984 Hatch-Waxman Act. The proposed regulation would allow generic manufacturers to alter an Abbreviated New Drug Application (ANDA) label without the FDA’s prior approval. We strongly believe that such a rule would conflict directly with the statute, thwart the law’s purposes and objectives, and impose significant costs on the drug industry and healthcare consumers. We respectfully request the Agency explain and reconsider this departure from more than two decades of settled practice.”

Regulatory burden will lead to higher costs for generics, they say