Major pharmaceutical companies continue to actively oppose a yet-to-be-finalized proposed rule that would require generic drug companies to update labels on products if they receive new safety information.
Generic makers currently do not have to make such changes unless the company that developed the original version of the product does so first. The U.S. Food and Drug Administration says the rule will make it easier for generic drug companies to pass on safety information.
The industry would rather wait until the FDA directs them to change their labels. But consumer groups disagree and want the agency to move forward as planned with the new rule.
These sentiments were shared both in a docket on the 2013 proposed rule (PDF) and a public meeting held March 27 at the FDA's headquarters in Silver Spring, Md.
“The labeling changes proposed … under the contemplated framework would arise primarily from spontaneous adverse event reports received by a single manufacturer,” Geoffrey Levitt, associate general counsel at Pfizer Inc., said in a comment letter. “Given FDA's unique ability to review safety information from all reporters, identify trends and develop and implement new active surveillance tools … the public health would benefit from prior FDA approval of safety-related labeling changes for multisourced drugs.”
Mylan, a global generic and specialty pharmaceuticals company, agreed, saying that if the FDA adopts its proposal as it now stands, it would put patients in danger.
“The proposed rule would comprise patient safety by, among other things, permitting different labeling for therapeutically equivalent products, thereby increasing confusion among prescribers and the public,” Ray Urbanski, chief medical officer at Mylan Inc., said in another letter posted to the docket.
Consumer groups find the FDA's proposal essentially sound and feel the industry's proposal would mean more of the same in which patients find out too late that their drugs may pose previously undisclosed threats to their health.
“It would increase the situations in which a drugmaker learns of important safety issues but is legally blocked from promptly alerting consumers,” George Slover, senior policy counsel with the Consumers Union, said in a March 27 statement sent to the FDA.
Dr. Michael Carome, director of Public Citizen's Health Research Group, echoed the remarks and added that he doesn't feel consumers will be confused by companies proactively updating their labels after being made aware of adverse events.
It's unclear what action the FDA will take. It reopened the public docket on the rule after closing it last year. The industry will have until April 27 to submit additional written comments on, as well as alternative proposals to, the proposed rule.
The FDA will determine next steps based on its analysis of comments, according to FDA spokeswoman Sandy Walsh.
