FDA Proposed Rule Would “Preempt” Supreme Court Rulings in Pliva and Bartlett

Last week the FDA announced a proposed Rule that would put generic manufacturers on the same “products liability” footing as branded manufacturers.  By requiring generic manufacturers to update their labels to take into account new safety information, the FDA rule would effectively overrule the Supreme Court’s holdings in PLIVA v. Mensing and Mutual Pharmaceutical Co., Inc., v. Bartlett, which effectively barred most state law products liability suits against generic drug manufacturers on federal preemption grounds.


As Pharmarisc readers know from earlier posts titled Fallout From Mensing/BartlettPay for Delay and Drug Design Defect Cases Take Center Stage at Supreme Court and Supreme Court Rejects Design Defect End-Around, the Supreme Court has ruled that products liability litigation based on state law “failure-to-warn” and “design defect” claims were preempted by FDA regulations governing drug design and labeling, effectively immunizing generic drug makers from products liability suits.  Since the FDA rules (according to the Court)  impose a “duty of sameness” on generic drug makers with respect to their products’ labels, prohibiting them from amending their labels, and since approximately 80% of drug products sold in the U.S. are generic, the rulings in Mensing and Bartlett left consumers injured by generic products with little or no recourse generic manufacturers.

The FDA’s proposed Rule would require an ANDA holder in possession of “newly acquired information” that constitutes “sufficient evidence of a causal association” between an unlabeled warning and the approved product to submit a Changes Being Effected-0 (“CBE-0″) supplement to their ANDA and immediately implement the changed labeling.  The Rule also allows the generic manufacturer to communicate the new warning promptly through a “Dear Doctor” letter and also will require that the changed labeling be submitted in “structured product labeling” (SPL) format, which will allow the FDA to promptly place the labeling change on websites such as Daily-Med.  However, since the generic manufacturer’s actions don’t affect other manufacturers’ labels, it must, at the same time it submits the CBE-0 supplement, notify the manufacturer of the original branded drug, or Reference Listed Drug (RLD) holder, in writing of the proposed labeling change.  The RLD holder will review the information and either propose a matching change in its labeling, or comment on the change proposed by the generic manufacturer.  Once the FDA approves a change to the RLD labeling, all ANDA holders would have 30 days to submit their own CBE-0 supplement covering that change.


Creating a duty on generic manufacturers to update their labeling, independent of any labeling change on the RLD, might seem the fair thing to do from the perspective of consumers injured by generic drugs, consumer advocates, politicians and (especially) plaintiffs’ lawyers.  It might even seem fair from the perspective of branded manufacturers that might otherwise be hauled into court by a plaintiff’s bar looking for “justice” from some responsible company.  However, the FDA’s proposed rule has also created more than a couple of thorny issues that a number of critics both inside and outside the generic industry have already begun voicing.

First, the rule will allow generic labeling to differ, at least temporarily, from the RLD product, thus undercutting the Hatch-Waxman Act’s mandate that generic and brand labeling be the same.  The sameness requirement will only be met once the RLD holder has submitted and secured approval of the labeling change initiated by the generic manufacturer.  Second, given the increased product liability risks to generic manufacturers, many believe that these manufacturers will act too quickly in submitting proposed labeling changes, diluting the effectiveness of any warning(s).  Third, because there are usually numerous (sometimes dozens)  generic versions of a given drug product, it is very likely that there will often be multiple and differently worded CBE supplements on the same drug, complicating not only a RLD labeling change, but creating mass confusion among health care providers and patients.  Moreover, by imposing a duty on generic manufacturers to update their labeling — and creating significant financial liability for generic manufacturers — the Rule could very well have the unintended consequence of driving up the cost of generic drug products — the opposite of what Hatch-Waxman was intended to do.  And for branded manufacturers believing “it’s about time” their generic counterparts got their “come-up-ins” from the plaintiff’s bar, think again:  once the plaintiff’s lawyers start filing products liability suits against generic drug manufacturers for not amending their labels quickly or well enough, the generics will be looking for any opportunity to haul  the branded manufacturers back into the fray.


About Jose Sierra

José P. Sierra is a Principal in the Boston and Delaware offices of Fish & Richardson. Prior to joining the firm, Mr. Sierra was Senior Vice President, Chief Compliance and Ethics Officer for Sepracor Inc., a specialty pharmaceutical company. Earlier in his career he held positions as Vice President, Chief Compliance and Ethics Officer for Kos Pharmaceuticals, Inc., Legal Director at Schering-Plough Corporation, and Assistant U.S. Attorney in the U.S. Attorney’s Office in Newark, New Jersey.

Mr. Sierra works in the firm’s pharmaceutical and medical device industry practices focusing on litigation, government investigations, qui tam/whistleblower defense, compliance, and risk management. Contact him at 617-956-5926 or via .

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