FDA chief fields tough questions about proposed new labeling rule for generic drug makers

fda logo FDA chief fields tough questions about proposed new labeling rule for generic drug makersFood and Drug Administration (FDA) commissioner Margaret Hamburg last week fielded tough questions from a Congressional committee regarding a controversial proposed rule that would allow generic drug makers to update their warning labels beyond what the brand name lists on its safety label, a move that would ignite a bevvy of personal injury lawsuits.

Currently, drug companies are required to bear the same safety labels on their generic drugs as their branded counterparts. Manufacturers of generic drugs cannot by law independently update their labels if the company becomes aware of new information about the drug, nor can they be held accountable if their medications injure or kill people provided they have the same exact warnings as the brand-name drug.

Last fall, the FDA proposed a new rule aimed at closing this loophole that excuses generic drug makers from adequately warning patients of harmful side effects. If the new rule goes into effect, both brand name and generic drug makers would be accountable for the safety of their products.

The inquiry comes as a result of a January letter in which the FDA admitted that it stepped out of practice and met with outside parties before issuing its rule. The meeting included Sarah Rooney, regulatory counsel for the American Association for Justice (formerly the Association of Trial Lawyers of America); Michael Forscey, a lobbyist for the association; and a personal injury attorney.

Rep. Kevin Yoder, R-Kan., questioned Hamburg why she didn’t meet with other third-party representatives. Hamburg replied that other parties were given the opportunity to comment on the proposed rule, and alluded to meetings with other parties as well.

Hamburg said that previous decisions that protected generic drug companies from failure-to-warn lawsuits, such as Pliva v Mensing, could reduce incentives for generic drug manufacturers to aggressively track data on side effects. As it is now, proponents of the new rule say people injured by generic drugs have little rescourse against makers of the generic drugs.

Until the rule is passed, supporters say, if no one is accountable, no one is safe.

Source: Law360