Groups Blast FDA For 'Bowing To Industry Pressure' After It Delays Generic Drug Label Rule

In 2013, the Food and Drug Administration proposed changing labeling rules to “create parity” between generic and brand-name drug makers for how they update their labels, exposing generic companies to legal liability if they failed to properly warn of a drug’s risks. The agency has announced it has decided to put off the decision until 2017.

The New York Times: F.D.A. Delays Rule On Generic Drug Labels

The Food and Drug Administration has decided to put off until 2017 a decision about whether to require generic drug makers to take more responsibility for warning patients about the risks of their products. The development dismayed consumer groups and representatives for trial lawyers, who had urged the agency to close a legal loophole that prevents patients harmed by generic drugs from suing manufacturers. (Thomas, 5/19)

In other pharmaceutical news —

Reuters: Valeant Gets Notice Of Default From Bondholders

Beleaguered Canadian drugmaker Valeant Pharmaceuticals International Inc said it received a notice of default from bondholders for the delay in filing its first-quarter report. The company said it can avert default by filing the report by July 18. Last week, Valeant had said it expected to file the report with U.S. and Canadian regulators on or before June 10, ahead of a July 31 deadline. (Grover, 5/19)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.

Trump 2.0

Public Health

Audio Reports

Special Reports

More Topics