FDA Moves to Blunt the Effects of the Supreme Court’s Mensing and Bartlett Generic Drug Preemption Decisions

By Kurt R. Karst –      

When the U.S. Supreme Court handed down its decision in Mutual Pharmaceutical Co. v. Bartlett (Docket No. 12-0142) on June 24th, ruling that state-law design-defect claims that turn on the adequacy of a drug’s warnings are preempted by the FDC Act and under the Court’s 2011 decision in PLIVA Inc. v. Mensing, 131 S.Ct. 2567 (2011), in which the Court held that FDA’s regulations preventing generic drug manufacturers from changing their labeling except to mirror the label of the brand-name manufacturer preempt state-law failure-to-warn claims against generic drug manufacturers (because it is impossible for generic drug manufacturers to comply with both federal and state duties to warn), we commented that the Court’s decision was unlikely to be the end of the matter and that the generic drug industry is likely in for more controversy on the preemption front.  After all, the United States, in an amicus brief in Bartlett, commented that “FDA is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances.  If such a regulatory change is adopted, it could eliminate preemption of failure-to-warn claims against generic-drug manufacturers.” 

We did not think it would take long for FDA to get the ball rolling on the promised “regulatory change.”  And we were correct.  The Office of Management and Budget (“OMB”) website was recently updated to show plans for FDA to issue a Notice of Proposed Rulemaking titled “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.”  According to the abstract posted on the OMB website:

This proposed rule would amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) to revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA’s review of such change. The proposed rule would describe the process by which information regarding a “changes being effected” (CBE) labeling supplement submitted by an NDA or ANDA holder would be made publicly available during FDA’s review of the labeling change. The proposed rule also would clarify requirements for the NDA holder for the reference listed drug and all ANDA holders to submit conforming labeling revisions after FDA has taken an action on the NDA and/or ANDA holder’s CBE labeling supplement. These proposed revisions to FDA’s regulations would create parity between NDA holders and ANDA holders with respect to submission of CBE labeling supplements.  [(Emphasis added)]

Obviously, the devil will be in the details of the proposed rule, which may be available within the coming weeks. 

Public Citizen, which announced the news in a press release, commented that the organization is “extremely pleased to see that [FDA plans] to issue a proposed rule to revise FDA regulations about prescription drug labeling.  When finalized, the revisions will fill a regulatory gap that poses a risk to patient safety.”  In August 2011, and just two months after the Supreme Court’s Mensing decision, Public Citizen submitted a Citizen Petition (Docket No. FDA-2011-P-0675) to FDA requesting that the Agency amend its regulations to permit ANDA sponsors to revise their labeling through the CBE and Prior Approval Supplement (“PAS”) procedures (see our previous post here).  On the same day the Supreme Court ruled in Bartlett, Public Citizen renewed its request for FDA to revise its regulations, and released a report detailing what the organization says are “significant labeling changes made after a generic drug came on the market during a five-year period.”

The extent to which FDA might effectively grant the Public Citizen petition in the Agency’s proposal to amend its labeling regulations remains to be seen.  But you can bet that there will be significant comment from interested parties.  One issue we’ll be on the lookout for is how FDA’s proposal might affect the so-called “RLD theory of liability.”  As we previously reported, the RLD theory posits that FDA’s regulations impose new or additional responsibilities on an ANDA sponsor whose drug product is unilaterally designated by FDA as an RLD, and that Mensing is inapplicable under such circumstances.  The theory has not gotten much traction in court, but that could change with FDA’s proposal. 

We’ll let you know once FDA’s proposal goes live.