Industry predicts dire consequences from FDA's generic labeling proposal

The FDA says it wants to level the playing field by having generic drugmakers independently update drug labels when there are known risks to the products. The industry feels as if it is being nudged off a cliff.

"The proposed rule would expose generic drug manufacturers to substantial new tort liability costs, which in turn would require them to adjust prices to stay in business, withdraw products, or decline to launch new affordable versions of brand medicines," Ralph Neas, president of the Generic Pharmaceutical Association, told a U.S. House subcommittee on health Tuesday, Reuters reports.

Under current rules, generic drugmakers are not allowed to update a label until the maker of a branded drug updates it, while branded drugmakers can make changes without FDA approval. That led to a 2011 U.S. Supreme Court ruling that while consumers can sue branded drugmakers for conditions tied to risks, a consumer taking a generic version would not have that recourse in federal court. Last year the Supreme Court extended that protection to state courts as well.

As Reuters points out, more than 80% of the drugs patients take now are generics and 45% of those no longer have a branded version in the market. That means there is no one to make safety updates to labels.

"The goal is to make sure the whole system is searching for safety problems and updating labels when they are found," FDA CDER Director Janet Woodcock told the committee in defense of the requirement change.

FDA CDER Director Janet Woodcock

The FDA has been asked by some Democratic members of Congress to make the change and has been lobbied by public interest groups. Proponents point out that the risk is no greater for generic drugmakers than before the Supreme Court provided them with a shield from lawsuits. They also point out that costs didn't go down when it did. In fact, some suggest the new rule would provide them with more protection than before the court ruled because it would allow generic drugmakers to make label changes as needed, whereas now they are prevented from acting until branded labels are changed.

But the generic drug industry, led by Neas' group, is fighting hard to kill the proposal. In an op-ed piece in the U.S. News and World Report, Neas argued that the new rule would lead to different versions of a drug having different labels, creating "confusion and uncertainty for prescribers and other healthcare professionals, with harmful consequences for patients."

- read the Reuters story
- here's the op-ed piece

Related Articles:
FDA to update generic labeling rules
U.S. Supreme Court protects generic drugmakers in 5-4 ruling
Justices weigh arguments in generic-liability case

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