FDA's generic drug labeling rule making comeback

The U.S. Food and Drug Administration's (FDA) controversial plan to let generic drug companies update their labels to reflect new and emerging safety information, thought to be quietly tabled, showed new signs of life this week.

Federal regulation currently prohibits generic drug products from bearing labeling that isn't borne by the product it references, which theoretically ensures that a generic drug isn't seen as more - or less - effective or safe than the non-generic product.

This practice has had some negative effects, with some generic drug companies unable to update labels to reflect new adverse events because the owner of the reference listed drug (RLD) no longer exists or because the brand name drug manufacturer has failed to push for an update, according to RAPS.org.

The Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products - a new rule proposed by the FDA in November 2013 - would allow a generic drug sponsor to immediately issue a labeling change for any safety-related change, which would start a process meant to allow differences to exist between the generic drug, the RLD and other approved generic drugs on a "temporary basis."

Labeling change applications would have to provide the basis for the change and available data supporting the change, including adverse event data, published literature or epidemiologic studies.

The rule, however, has not been welcomed with open arms. It is strongly opposed by generic drug companies, which say that it could expose them to billions of dollars in annual legal liabilities and increased pharmacovigilance monitoring costs, RAPS.org said.

Legislators have also questioned the legality of the proposed ruling, warning that the Hatch-Waxman Act of 1984 does not permit the FDA to authorize differences in labeling.

As a result, the FDA announced in December that it would delay finalizing the rule until 2015.

In a Federal Register notice published on Tuesday, however, the FDA announced that it would reopen the comment period for the proposed regulation as a result of both the significant amount of interest in the proposal, and the emergence of alternate proposals put forth and endorsed by the generic pharmaceutical industry.

The comment period runs through April 27.

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