FDA Scraps 2013 Generic Drug Label Proposal That Could Have Exposed Manufacturers to Lawsuits

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The U.S. Food and Drug Administration (FDA) is backing off a 2013 proposal that could have opened generic drugmakers to potential lawsuits over the side effects of medications. On Thursday, the regulatory agency withdrew its proposal for that rule, keeping the drug manufacturers safe from those kinds of lawsuits.

In 2013 the FDA proposed the rule called Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. If the rule had been finalized, it would have allowed drugmakers to independently update and distribute new safety information on drug labels, something that only branded drug makers can do. If the rule had gone into effect, the generic drugmakers could have provided safety updates without oversight from the FDA. In a statement issued Thursday, the FDA said the policy could have resulted in labels for the same drug, but made by different manufacturers, to have different safety data on the boxes.

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Not only that, but the FDA said that had the new rule been implemented, it could have led to an increase in the cost of generic drugs that could lead to a risk of drug shortages and a less competitive marketplace.

In its report on the action, the Wall Street Journal said the proposal was something that many generic drugmakers actually opposed at the time it was introduced because it would open them to potential lawsuits. The proposal rose following a 2011 Supreme Court decision that said generic drugmakers could not be sued over a failure to warn about adverse side effects. The reasoning behind the ruling, according to the Journal, is that generic drugmakers do not have the authority to modify their safety labels.

When the FDA announced its intention to withdraw the proposed change, it was done so after “robust public debate,” the regulatory agency said.

“We’ve carefully considered all of the feedback we received from the various stakeholders – both in favor of and against the proposed rule. We’ve evaluated whether there are more effective and efficient ways of keeping generic drug labels up-to-date with the latest safety information and helping to ensure that generic companies continue to engage in an appropriate level of post-market safety surveillance,” FDA Commissioner Scott Gottlieb and drug-center director Janet Woodcock said in a statement. “Fundamentally, we believe that the withdrawal of the proposed rule is in the best interest of the public; and that other steps that we’re pursuing can achieve our goals.”

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