Generic drug makers await FDA decision on labeling regulation

Critics warned that a Food and Drug Administration proposal to make generic drug manufacturers more involved in the labeling process would have dire consequences for them, while supporters argued that the rule is essential to protect consumers. The public comment period for the proposed regulation ended Thursday.

The regulation would require generic drug makers to proactively update labels with new safety information instead of waiting for brand name manufacturers to do so.

Since it was introduced last year, the proposal has generated a firestorm of criticism from generic drug manufacturers and other industry groups who say, if enacted, it would have “unintended negative consequences,” like price increases, leaving generic drug manufacturers vulnerable to lawsuits and posing potential threats to patient safety.

“The proposed rule creates the regulatory framework whereby multiple, different labeling, including different warnings, can simultaneously exist in the marketplace for multiple generic versions of a drug,” warned more than 20 groups in a joint letter sent Wednesday to FDA Commissioner Dr. Margaret Hamburg. The proposal as drafted would “have a chilling effect on the ability of generic manufacturers and others in the pharmaceutical supply chain to provide affordable medicines to millions of Americans and people across the globe,” they said.

Other dissidents said that although there is merit to changing the existing law, they disagree with the approach.

“It would be far more efficient and effective for the FDA to either review and update generic drug labels itself or adopt a more rational and logical oversight process,” Dr. Scott Gottlieb and colleagues, Alex Brill and Robert W. Pollock, wrote in a report this week (PDF) from the American Enterprise Institute for Public Research. From a patient safety perspective, they say, the change would create confusion among both consumers and providers.

Amid growing criticism, a group of more than 41 lawmakers from Senate and House Committees offered support last week, submitting their own letter to the commissioner.

The rule is “critically important,” they say, to ensuring that the public is informed as soon as possible about new safety information and that labeling for a prescription drugs remain up-to-date. The lawmakers also address a loophole in which a generic drug manufacturer may not have a brand name version to follow and may therefore have no incentive to make labeling updates.

“In such instances, generic manufacturers will have the best knowledge of adverse events; indeed, they may be the only manufacturers left in the market to monitor a product and ensure its labeling is up-to-date,” said the legislators in the letter.

That loophole became the focus of widely publicized U.S. Supreme Court cases, including Pliva v. Mensing, which held that manufacturers of generic drugs cannot be held liable under state tort law for “failure to warn,” even in cases where the manufacturer knows a label is inadequate.

To address the issued highlighted in that case, senators Patrick Leahy (D-Vt.), Al Franken (D-Minn.), Jeff Bingaman (D-NM), Sheldon Whitehouse (D-R.I.), Sherrod Brown (D-Ohio), Christopher Coons (D-Del.) and Richard Blumenthal (D-Conn.), proposed legislation on Nov. 13.

Other supporters also posted letters before the comment period ended. Members of the Patient, Consumer, and Public Health Coalition, for example, wrote that current requirements are not as effective as they should be, and from a public health perspective, “a patient's ability to seek redress when harmed by inadequately labeled drugs should not depend on whether they were harmed by a brand-name or generic version of a drug.”

The FDA said it will review all comments as it formulates a final rule. “We cannot speculate as to when the rule will be finalized,” an FDA spokesperson said.

Follow Sabriya Rice on Twitter: @MHSrice