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FDA Extends Comment Period for Changes to Generic Drug Warnings

News / May 30, 2016

A New Rule Would Have Generic Drug Manufacturers Control Their Own Warning Labels, Allowing Consumers to Seek Compensation for Injuries Following Generic Drug Use.

In the Spring of 2011 the Supreme Court heard Pliva, Inc., et al. v. Mensing. After experiencing extreme side effects, several plaintiffs sued Pliva Pharmaceuticals, the manufacturers of a generic form of Reglan, an anti-nausea medication. Their argument was that Pliva knew of these extreme side effects but failed to warn consumers of the danger, however the case was complicated by a federal mandate that all labels on generic drugs must match the labels of the name brand drugs.

FDA generic drug proposalThis mandate is in place because in order for generic drugs to be approved by the FDA, they must simply prove that their composition is the same as the name brand drugs that went through a more rigorous approval process. Generic drug manufacturers cannot change the labels on their drugs until the brand name drug labels have been changed. This rule contradicts with state laws that require all drug manufacturers to adequately warn the public of possible side effects. The attorneys for Pliva argued that the company could not change their label without violating federal law.

In a 5-4 decision, the Supreme Court ruled in favor of Pliva partly because the federal ruling takes precedence over the state law and had Pliva changed their label, they would have violated federal law. Essentially, generic drug manufacturers can’t be held responsible for the content of their warning labels because they have no control over the warning labels. The decision, which applies to all manufacturers of generic drugs, left millions of generic drug users without recourse in the event that they are injured.

In 2013 the FDA announced a plan that might remedy the loophole the Supreme Court ruling created. The FDA’s proposed rule would allow generic drug manufacturers to alter their labels – opening the manufacturers back up to lawsuits when they fail to warn of dangerous side effects. After several years of delays, the FDA announced on May 18th of this year that they were extending their comment period on the proposal until 2017, after the Presidential election – and a new Supreme Court Justice has been appointed.

Attorneys for the pharmaceutical companies aren’t pleased with the proposal, they feel it is a government intrusion into business practices. Justice advocates are ready for the proposal to take place, so all prescription drug users have the ability to seek compensation when they’ve been injured by a drug. The new ruling would have implications for prescribing physicians, pharmacists, and the pharmaceutical industry. The FDA comment period will be open until April of 2017.