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I confess that I am either uniquely qualified or uniquely disqualified to address federal pre-emption of state laws on drug labeling. Although in a number of important instances in the past the Food and Drug Administration had asserted in litigation and regulations that certain of its decisions or rules pre-empted conflicting state law, I was the agency’s chief counsel when the FDA began to do so on a more frequent basis, beginning in 2002. I was also at the FDA while January’s Physician Labeling Rule, which contains a statement in its preamble about the FDA’s pre-emption authority, was written. And I now advise and represent companies confronting state-law claims that implicate the pre-emptive effect of FDA requirements. That said, the FDA has continued to assert that its decisions can pre-empt state law. And a number of federal courts have now evaluated the FDA’s January statement about the pre-emptive effect of its labeling regulations. A few decisions�most notably, one in the Eastern District of Pennsylvania case Colacicco v. Apotex, issued at the end of May, and subsequent twin decisions by U.S. District Judge Charles Breyer of the Northern District of California in multidistrict litigation�stand out for the depth of their analysis. These particularly noteworthy decisions have implications for companies currently confronting state-law claims that threaten to undercut or displace the FDA’s decisions. But more broadly, the rulings also are relevant to drug companies’ internal organizations and interactions with the FDA, as well as to the public health. STATE WARNINGS First, some background. In 2000, toward the end of the Clinton administration, the Department of Justice, which represents the FDA in court, filed a brief maintaining that state law could not compel Pfizer to send out a “Dear Doctor” letter about the prescription medicine Warfarin. That remedy, the Justice Department contended, was exclusively the province of the FDA, which comprehensively regulates the communication of risks and benefits about medicines. In 2002 the FDA became involved in a citizen suit under California Proposition 65 that sought to require a warning on nicotine-replacement therapies. The FDA had found the proposed warning�that nicotine in the smoking-cessation treatment could “harm your baby”�was not scientifically supportable. The agency was concerned that the warning could cause pregnant women to conclude, mistakenly, that using a replacement product was as dangerous as smoking. The California Supreme Court agreed with the FDA. Citing concerns about “over-warning,” it overturned the appellate court and held that state law could not impose a warning the FDA had specifically rejected. That same year, the FDA submitted a brief to the U.S. Court of Appeals for the 9th Circuit opposing a state-law effort to require Pfizer to warn that the anti-depressant medicine Zoloft caused suicide. The FDA noted that it had repeatedly considered whether such products increase the risk of suicidal thoughts and behavior. Each time, the FDA, sometimes advised by an expert committee, had concluded such a warning was scientifically unjustified. The agency maintained that the very warning the plaintiff said that state law required would have misbranded the drug, in violation of federal law. The 9th Circuit upheld the lower court’s dismissal of the complaint on other grounds and never addressed pre-emption. But lawyers began relying on the FDA’s brief to support their pre-emption arguments in other cases involving antidepressants. During this same time the FDA had pending before it a rulemaking that had begun in 2000. For years the agency had been concerned about drug package inserts. These documents were growing increasingly cluttered, in part because of “defensive labeling” in response to product-liability risks. The FDA proposed a major overhaul to make inserts easier to navigate�namely, requiring a table of contents and a half-page “highlights” section at the beginning of each insert. To aid physician prescribers, the FDA was proposing to limit the size of the highlights section as well as to limit the risks discussed in highlights to the most significant only. A number of those commenting contended that the highlights section would dramatically increase a drug maker’s vulnerability to a failure-to-warn claim under state law. Companies worried that plaintiffs would claim a company had failed to warn adequately because it placed risk information someplace other than in the highlights section. To address this issue the FDA included in the rule what has come to be known as the “Preemption Preamble.” That discussion clarifies the FDA’s view that “whether it be in the old or new format, the Food, Drug and Cosmetic Act preempts conflicting or contrary state law,” including state failure-to-warn claims. The FDA also took on two arguments that some courts have relied on to reject pre-emption. First, the agency made clear that its decisions about what and how risks and benefits should be presented establish both a floor and a ceiling. Second, the FDA clarified that, even if its regulations might seem to allow companies to add warnings without prior approval, “in practice, manufacturers typically consult with FDA before doing so to avoid implementing labeling changes with which the agency ultimately might disagree.” The FDA’s bottom-line concern is that “state-law attempts to impose additional warnings can lead to labeling that does not accurately portray a product’s risks, thereby potentially discouraging safe and effective use of approved products.” UPHOLDING THE AGENCY A few courts have refused to defer to the Preemption Preamble and have rejected pre-emption on a variety of grounds. But few, if any, of those decisions carefully analyze the nature and extent of the FDA’s decision-making or the degree of deference due to the FDA’s views. Perhaps the most comprehensive analysis is Judge Michael Baylson’s decision in Colacicco. In that case a husband claimed that his wife had committed suicide because the brand and generic manufacturers of the antidepressant Paxil had failed to warn about the increased risk of suicidal behavior. At the court’s request the FDA weighed in and reiterated what it had said in the 9th Circuit Zoloft brief�i.e., these claims were impliedly pre-empted because, as of the date of the wife’s suicide, the agency had repeatedly concluded that there was not enough evidence of a link between adult use of the product and suicide. In addition, the generic manufacturer was actually precluded from adding the warning for another reason�namely, under the relevant rules, the generic drug labels have to essentially mirror those of the innovator. The Colacicco court extensively analyzed the deference due to the FDA’s pre-emption analysis and concluded that, although the amicus brief alone would warrant deference, the Preemption Preamble also caused the failure-to-warn claims to be impliedly pre-empted. In so finding, the court relied on Chevron principles, Supreme Court pre-emption decisions, and a recent 3rd Circuit decision deferring to the FDA’s views on pre-emption in the context of medical devices. The case has been appealed, and the 3rd Circuit may consider it with a just-issued ruling that takes a contrary approach. In the Northern District of California, Breyer’s first decision took a slightly different tack. He dismissed, with limited leave to amend, allegations that the prescription medicine Celebrex had been marketed unlawfully because the manufacturer allegedly failed to warn about the drug’s cardiovascular risks. The judge based the ruling on the grounds that the claims “conflict with the FDA’s determination of what warnings are substantiated by the scientific evidence.” He refused, however, to dismiss as pre-empted claims that certain promotional materials were false and misleading. He allowed those to go forward at the motion-to-dismiss stage only to the extent that plaintiffs could show that the company’s actions were in any way “contrary to the FDA’s findings.” At bottom, Breyer believed that the “FDA is in a better position than the Court to determine whether state laws that encourage manufacturers to propose defensive labels upset the careful balance of FDA’s statutory objectives.” ALIGNING INCINTIVES Decisions like these two are having profound effects. There is no question that the current product-liability environment represses innovation, limits access, increases prices, and interferes with rational prescribing decisions. For years companies have, for understandable reasons, steered away from developing products that carry high liability risks, such as treatments for pregnant women. To illustrate, the only therapy ever approved for morning sickness, Bendectin, which the FDA continues to believe is safe and effective, is available in Europe but not in the United States. It was removed from the U.S. market only because of spurious lawsuits. As the Preemption Preeamble gains traction, companies are able to devote research dollars to treat conditions that have been perceived as too risky, not for scientific reasons but for legal ones. A reduction in specious product-liability suits should also, over time, enable companies to charge less for their lifesaving medicines. The second important effect of the Preemption Preamble is how companies are organizing themselves and interacting with the FDA. One reason the FDA issued the pre-emption statement is to align even more closely the industry’s incentives with the FDA’s desires. The agency wants to find out as much as possible, as quickly as possible. Thus, savvy companies are doing what they can to improve coordination among their drug-safety, regulatory, and legal teams, including the product-liability lawyers. This will allow them to evaluate issues more quickly and more accurately so they can respond to the FDA faster and better. Savvy companies also are recognizing that how they interact with the FDA today may profoundly affect their pre-emption defenses in the future. They are trying to ensure their communications with the agency are as formal as they can be in light of commercial considerations and the need to stay on the FDA’s good side. More formal communications can help buttress a future case for why a particular state law claim should be pre-empted. Finally, companies are presenting the FDA with more affirmative questions about what should and shouldn’t be in labeling. Because, at the end of the day, the drug label reflects, as the FDA puts it, “formal, authoritative conclusions regarding the conditions under which the product can be used safely and effectively.” And that is precisely why state-law claims that undercut the FDA’s scientific decisions should be and are pre-empted. Daniel E. Troy is a partner in the D.C. office of Sidley Austin, where he specializes in food and drug law as well as administrative litigation. He was the FDA’s chief counsel from August 2001 until November 2004. He now chairs the American Bar Association’s Section of Administrative Law and Regulatory Practice. He may be contacted at [email protected]

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