Preemption Update: FDA’s New Rule

Maddeningly, the Bush FDA continues overtly to spend time distracted from its mission – industry oversight and public safety – and instead, toil in support of the interests of the industries it is charged with regulating. Indeed, even as its end is near, the Bush FDA persists in waging its misguided war on drug and device litigation, attacking now with somewhat more precision that it has in the recent past. On August 22, 2008, in the form of a Final Rule published in the Federal Register, the FDA announced amendments to certain labeling regulations for prescription drugs, biologics, and medical devices. 73 Fed. Reg. 49603 (Aug. 22, 2008), available at

The regulation amendments, which were initially proposed in January 2008, will take effect on September 22, 2008. In essence, the changes will ease the duty of product manufacturers to warn consumers about risks by allowing manufacturers to make labeling changes based only upon “newly acquired information” and only to warn of risks where there is “evidence of a causal association.”

With respect specifically to prescription drugs, the Final Rule amends 21 C.F.R. § 314.70 (Supplements and other changes to an approved application). The current version of Section 314.70, which remains in effect until September 22, 2008, is notable in several respects. First, it draws a distinction between those changes to a prescription drug that are permitted only with both prior notice to the FDA and prior FDA approval, see § 314.70(b), and those that are permitted with only prior notice to the FDA. See § 314.70(c). Changes to a drug’s labeling “[t]o add or strengthen a contraindication, warning, precaution, or adverse reaction” fall under the latter subsection. See § 314.70(c)(6)(iii)(A). Labeling changes of this nature have always been permitted without prior FDA approval. Second, subsection (c) is notable because it specifically makes discretionary the FDA’s response to a company’s supplemental submission under that subsection. Indeed, subsection (c)(7) states only that “if” the FDA disapproves of the supplement, it “may” order the company to cease distribution of the product with the accompanying change. See § 314.70(c)(7). In that way, the rule might be said to be doubly discretionary because it does not require the FDA to act on a subsection (c) supplement at all, and in the event that the FDA chooses to announce any disapproval of the change in question, it has discretion as to whether or not it will actually take action against the company.

In short, Section 314.70 highlights a straightforward and incontrovertible regulatory truth: the FDA itself has expressly authorized prescription drug manufacturers to unilaterally change drug label warnings, and when a company does so, the FDA is obligated to do absolutely nothing in response. Understandably, Section 314.70(c) has been a central feature of plaintiffs’ attorneys’ rebuttal to the conflict preemption argument in prescription drug cases. Obviously, in view of the plain text of Section 314.70, the prescription drug industry’s typical implied conflict preemption argument – i.e., that concurrent compliance with both FDA regulations and state tort suits sounding in failure to warn is “impossible” – rings rather hollow.

Against that backdrop, the upcoming amendment to Section 314.70 can hardly be considered coincidence. Whereas, the FDA’s prior efforts in the courts on behalf of the drug and device industries has come in the form of more ethereal means – e.g., amicus curiae briefing extolling the virtues of centralized decision-making and the now infamous “preemption preamble” to the FDA’s 2006 Rule Amendments – this latest effort is a more concrete affront to plaintiffs’ arguments. Indeed, the FDA’s addition of the “newly acquired information” and “causal association” requirements to Section 314.70 is an obvious effort to curtail plaintiffs’ reliance on the text of that regulation as direct support for (1) manufacturers’ ability to comply with both state failure to warn claims and federal labeling regulations, without conflict, and (2) the conception of federal labeling regulations as mere “minimum standards.” Of course, two features of the regulation will remain in tact – the ability of manufacturers to effectuate labeling changes without prior express approval from the FDA and the fact that any FDA response to such labeling changes is merely discretionary.

The good news for plaintiffs and consumers is that the changes cut against implied conflict preemption in all currently pending litigation and in all cases where the manufacturer’s alleged labeling deficiency occurred prior to the upcoming amendment effective date of September 22, 2008. Indeed, in adding two new requirements that must be met before a company unilaterally warns consumers and physicians about a given risk, the FDA is only acknowledging what plaintiffs have been arguing all along: current Section 314.70 is permissive rather than restrictive and cannot be perceived as the federal regulation “rock” to a state failure to warn claim’s “hard place.” In other words, once the new text takes effect and it becomes more difficult for companies to unilaterally warn under the federal regulations, it will correspondingly become more difficult for companies to claim that it was “impossible” to issue warnings under the current text.

Of course, the FDA attempts to nip that common sense argument in the bud by commenting repeatedly in its publication that the amendments merely “clarify” current “longstanding” procedures, that the agency does not believe that the amendments make it more difficult for manufacturers to strengthen labeling, and that the “rule is intended to describe FDA’s existing labeling standards and policies.” 73 Fed. Reg. at 49604. That rhetoric is no doubt meant to afford manufacturers an inroad to claim that Section 314.70 has always been restrictive. But the FDA and industry surely appreciate that such a position overreaches and amounts to little more than a thinly veiled, and likely unsuccessful, retroactivity argument.

It is probably most appropriate to understand the September 2008 amendments as the Bush FDA’s last-ditch effort to meaningfully advance its tort reform agenda for times to come – an attempt to lay groundwork for shielding companies from liability for future misdeeds. So the real question is: how will the amendments shape the conflict preemption debate for all interested parties going forward? The threshold answer is that, after the Supreme Court decides Wyeth v. Levine (see our prior blog entry about this upcoming Supreme Court case) the amendments might not matter. But assuming that Levine is decided in any way that makes the conflict preemption question turn on a factual inquiry, future arguments surely will center on what constitutes “newly acquired information” and whether a given company had evidence of a “causal association” between its drug and the risk in question.

But, in truth, the FDA’s Final Rule accomplishes very little for the drug industry in the way of future certainty as to the definitions of those terms. Most notably, the FDA defines “newly acquired information” rather broadly, explaining that it can be information arising from either “new clinical studies, reports, or adverse events, or new analyses of previously submitted data (e.g., meta-analyses).” 73 Fed. Reg. at 49604 (emphasis added). A manufacturer’s federal obligation to strengthen labeling based on the latter category would not appear necessarily to be at odds with common law negligence principles that would hold the manufacturer accountable for what it should have known. In other words, if a given drug risk could be gleaned from a fresh look at data in the company’s possession – even if that same data had already been turned over to the FDA – then the company could be found not only in violation of a common law negligence duty but also in dereliction of its obligation under the new Section 314.70(c)(6)(iii). Similarly, the addition of the “causal association” requirement merely parallels an element – proximate legal causation – that is required to prove a negligence claim under any state’s common law.

In our view, the September 2008 amendments serve mainly to underscore the present absence of any tangible conflict between federal labeling regulations and state failure to warn claims. And not to be lost in the fray of the agency’s transparent effort to secure preemption for the future is the reality that the text of the new labeling regulations will continue to belie any suggestion of an actual conflict between federal and state laws.