Generic Drug Labeling Preemption: The Flavor of the Day

By Kurt R. Karst –

It was only about a year ago when the topic du jour was generic drug labeling and whether federal law – the FDC Act and FDA’s implementing regulations – preempts state-law product liability claims (failure-to-warn, design defect, failure-to-conform/update, etc.) against generic drug manufacturers.  In fact, we were so inundated with generic drug labeling preemption issues at the time that we titled a March 13, 2013 post “Preemption, Preemption, and More Preemption.”  

Well, it’s happened again.  It seems that hardly a day goes by now without something new happening in the generic drug labeling preemption arena.  Of course, back in 2013, the hubbub was all about the U.S. Supreme Court’s consideration of Mutual Pharm. Co., Inc. v. Bartlett, 133 S. Ct. 2466 (2013) (subsequently decided) and the Court’s previous decisions in PLIVA Inc. v. Mensing, 131 S.Ct. 2567 (2011) (holding 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) and Wyeth v. Levine, 555 U.S. 555 (2009) (holding that a state-law tort action against a brand-name drug manufacturer for failure-to-warn is not preempted).  In Bartlett, the Court held 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 decision in Mensing.  The fallout of those decisions (in addition to a multitude of court decisions all over the map, such as in Pennsylvania – see our previous post here – and a recent decision out of Illinois in Dolin v. Smithkline Beecham Corp. concerning brand-name manufacturer liability for a generic version of its drug product) was FDA’s November 13, 2013 proposal (see our previous post here) to allow generic drug manufacturers to independently update product labeling (with respect to product safety) through the Changes Being Effected (“CBE-0”) supplement process that is currently only available to brand-name drug manufacturers whose products are approved under an NDA. 

FDA’s ANDA CBE-0 proposal has resulted in the bivouacking of various parties in anticipation of what could be many skirmishes and a protracted battle over the future of the generic drug industry. 

Not long after FDA published its proposal, several Republican members of Congress expressed “grave concerns” about the proposed rule in a letter to FDA Commissioner Margaret Hamburg, M.D.  As we previously reported, the lawmakers express the belief that FDA’s proposal “would conflict directly with the statute, thwart the law’s purposes and objectives, and impose significant costs on the drug industry and healthcare consumers,” and requested that the Agency “explain and reconsider this departure from decades of settled practice.”  FDA lodged its response in a a February 26, 2014 letter to the lawmakers.  In that response, FDA cites to the Agency’s Preliminary Regulatory Impact Analysis concerning some of the cost issues raised by the lawmakers, and also clarifies the proposal.  For example, FDA comments that “[d]uring its review of a generic drug manufacturer’s [CBE-0] supplement, FDA would consider submissions by the brand drug manufacturer and other generic drug manufacturers related to the safety issue and determine whether the labeling update is justified and whether modifications are needed.”  In that case, “FDA would make an approval decision on proposed labeling changes for the generic drug and the corresponding brand drug at the same time, so that brand and generic drug products have the same FDA-approved labeling.”

The Generic Pharmaceutical Association (“GPhA”) has also expressed its own concerns about FDA’s proposal.  In February, GPhA put out an Overview and Assessment of FDA’s proposal saying that it is unjustified and unwarranted (see our previous post here).  A follow-up economic assessment concludes that FDA’s proposal, if implemented, would result in an estimated $4 billion in additional U.S. health care costs annually.  More recently, GPhA hosted a briefing on Capitol Hill highlighting its concerns about the proposal, and showcased a March 6, 2014 letter sent to FDA by myriad healthcare organizations saying that “FDA and others need to fully explore the potential unintended consequences that the Rule may have on patient access and national health care costs,” and that “[p]ermitting labeling changes for generic drugs without FDA approval counters 30 years of law requiring generic and brand medicines to have the same labels.”

Those forces in favor of FDA’s November 2013 proposed rule are also gathering.  Last week, just three days after a hearing on FDA’s proposal before the House Committee on Energy and Commerce Subcommittee on Health was postponed, a group of Democrat lawmakers announced that they had sent a letter to FDA supporting the proposal. 

According to the bicameral group of lawmakers, who urge FDA to prioritize the release of a final rule, the Agency’s proposal “is critically important to ensure that the public is informed as soon as possible when new safety information becomes available, and to ensure that labeling for a prescription drug remains up-to-date even when the branded drug is no longer being marketed or has not undergone a labeling update to reflect newly discovered risks.”  And not only does “[e]mpowering a drug manufacturer to update certain safety information while FDA reviews the change, instead of requiring prior FDA approval” (emphasis in original) make good sense they say, because it “will allow generic drug manufacturers to communicate safety information in a timely way,” but it helps incentivize generic drug manufacturers given concers about tort liability:

The Proposed Rule achieves an important public safety goal by restoring these incentives for generic manufacturers to warn consumers of safety risks.  Especially in light of resource constraints facing FDA, the potential for tort liability provides an important tool in incentivizing compliance with existing reporting obligations, to the benefit of American consumers.

This is certainly not the last word we’ll hear about FDA’s proposal.  As noted above, we’re just in the set-up stage to the battle.