Fallout From Mensing/Bartlett: FDA Proposes Leveling The Labeling Playing Field Between Brandeds and Generics

In response to growing pressure from lawmakers and consumer groups, the FDA recently announced plans in a July 3, 2013 notice posted by the OMB to issue a rule in September that would allow generic drug makers to change their labeling based on new information.  If approved and implemented, the new rule would effectively overrule the Supreme Court’s decisions in PLIVA, Inc. v Mensing and Mutual Pharmaceutical Co., Inc., v. Bartlett, enabling the plaintiffs’ mass tort bar to go after generic drug manufacturers for personal injuries caused by their products.


As I have discussed in earlier posts titled Pay for Delay and Drug Design Defect Cases Take Center Stage at Supreme Court and Supreme Court Rejects Design Defect End-Around Of Pliva v Mensing Ruling, 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 the overwhelming majority 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 promises to give both generic and branded pharmaceutical drug companies greater flexibility to make labeling changes.  Specifically,  the new rule will amend the regulations for:

  • New drug applications (NDAs)
  • Abbreviated new drug applications (ANDAs), and
  • Biologics license applications (BLAs)

The FDA’s proposed rule was included in a Government agenda of new rules under consideration by federal agencies and was drafted to “create parity” between makers of brand-name drugs and their generic versions in their ability to change drug labels.  In the future, labels and warnings may be modified based on “newly acquired information” prior to an FDA review of the data, according to the notice.  Technically, the rule would allow generic manufacturers to change their labeling using a “changes being effected” (CBE) supplement without prior FDA approval, leaving it to the FDA to reject the change after it is made.


Although the FDA’s recent proposed rule came as no surprise, up until the announcement the tide of political pressure seemed to always pound the branded drug industry because of high drug prices that lawmakers and consumer groups dislike.  In fact, with the exception of generic drug makers who got reverse payment settlement deals, a reliable consortium of plaintiffs’ lawyers, consumer advocates, politicians and commentators almost always sided with generic drug makers in disputes with their branded competitors.  In the aftermath of the FDA’s announcement, the plaintiffs’ bar and others were quick to endorse the agency move:  “We think this is a great first step toward making generic drugs safer [by holding makers of generic and brand-name drugs] equally responsible [for drug safety,” said a representative from the American Association for Justice, a professional association for plaintiffs’ lawyers.  Senator Patrick Leahy (D. Vt.) “welcomed” the FDA decision, noting that a “consumer should not have her rights foreclosed simply because she takes a generic version of a prescription drug.”

For branded drug makers, the FDA’s proposed rule is more than just an interesting development to be observed from the sidelines.  Absent a leveling of the playing field for plaintiffs’ lawyers and their injured clients, branded drug makers would continue to face the risk that some state courts might allow lawsuits against them for injuries caused by generic versions of their products, as has already happened in state courts in Vermont, California and Alabama.  It has been said that politics makes for strange bedfellows and when the branded drug industry finds itself in bed with plaintiffs’ lawyers, nothing could be stranger.



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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