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Recently, the U.S. Food and Drug Administration announced in a preamble to its new drug labeling rules that, in its view, failure to warn and some other tort claims against drug manufacturers by injured patients are pre-empted by federal law. 71 Fed. Reg. 3922 (Jan. 24, 2006). Drug companies, their lawyers and some commentators have lauded this announcement as the latest, greatest development in the fight against tort liability, opining that courts will almost certainly defer to the FDA’s views on pre-emption. This is a good thing, they argue, because tort claims alleging inadequate drug labels conflict with-and undermine-the federal government’s exclusive authority to regulate drug labels and create an incentive for drug makers to overlabel drugs. They’re wrong on all counts. To begin with, it is readily apparent that the FDA’s attempt at pre-emption by regulatory fiat should not be entitled to any legal deference whatsoever. First, although an agency’s view on the pre-emptive effect of its regulations is sometimes given some weight by a reviewing court, the preamble is merely an advisory opinion, and has no legal effect whatsoever (unlike the regulations themselves). Second, the U.S. Supreme Court has repeatedly held that an agency’s views are not entitled to any weight when it has taken inconsistent positions in the past. Just last year in a case involving a defective pesticide that killed the crops it was supposed to protect, the Supreme Court flatly rejected the United States’ argument, set forth in an amicus brief, that federal law pre-empted tort claims against a manufacturer alleging design defect and failure to warn. Bates v. Dow Agrochemical, 544 U.S. 431 (2005). The court chastised the Environmental Protection Agency for changing its views over time, stating that its inconsistent positions on pre-emption rendered its arguments “particularly dubious” and not entitled to deference. The same is true of the FDA’s recent pronouncement on pre-emption. In fact, when the FDA first proposed this labeling rule in 2000, it stated that the rule “does not preempt state law.” 65 Fed. Reg. 81,082, 81,103 (Dec. 22, 2000). This is not surprising, since the vast majority of courts to consider the issue at that time had reached the same conclusion regarding the pre-emptive effect of FDA regulations. Prior FDA labeling rules had been equally clear. See, e.g., 44 Fed. Reg. 37,434, 37,437 (June 26, 1979); 63 Fed. Reg. 66,378, 66,384 (Dec. 1, 1998). This consistent position is in keeping with a 1996 speech by the agency’s chief counsel, stating that the “FDA’s view is that FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection.” Margaret Jane Porter, “The Lohr Decision: FDA Perspective and Position,” 52 Food & Drug L.J. 7, 11 (1997). Indeed, it was not until President Bush appointed a leading drug industry lawyer as FDA chief counsel in 2001 that the agency began taking the side of drug makers against injured patients in failure-to-warn cases. Given this recent U-turn in policy, it is hard to imagine that the FDA’s new views will be given deference by any reviewing court. Nor is the FDA’s position defensible on the merits. The FDA’s argument is that common law claims involving drug labels undermine the agency’s authority to make “formal authoritative conclusions” about the content of labels. It further argues that it would harm public safety to permit “lay juries” to impose different labeling requirements. These arguments ignore the fact that manufacturers are already permitted to supplement their labels at any time without prior FDA approval, in order to warn of newly discovered risks. Thus, the idea that FDA requirements set any kind of “ceiling” for drug labeling is fanciful. The arguments about the dangers of “overwarning” ignore the fact that a jury verdict holding a manufacturer liable for failure to warn does not force it to change its label; the holding merely compels it to pay damages to an unwitting victim of adverse drug effects. FDA caters to industry The FDA’s attempt to pre-empt tort claims can only be viewed as a legally baseless attempt to cater to the industry to which it has become captive. According to records analyzed by the Center for Public Integrity, drug companies spend more on federal lobbying and campaign donations than any other industry in the United States-more than $800 million since 1998, including $1.5 million that went straight to the Bush campaign. See M. Asif Ismail, The Center for Public Integrity, “Drug Lobby Second to None” July 7, 2005, www.publicintegrity.org/rx/report.aspx?aid=723. And lobbying is not the only way the industry influences the FDA. Fees paid directly by the drug makers under a 1992 law account for more than $260 million of the FDA’s annual budget, and pay the salaries of half of the staff responsible for making drug-approval decisions. Marcia Angell, The Truth About the Drug Companies 208-09 (2005). Meanwhile, the FDA’s regulation of the industry has become more relaxed. It is approving new drugs more quickly-and pulling dangerous ones from the market more slowly-than ever before. Also, the annual number of FDA “warning letters”-the first step in disciplining drug makers for violating marketing rules-has steadily dropped since 2000. See www.publicintegrity.org/rx/report.aspx?aid+722. It’s no wonder that, by the time the FDA tells drug makers to warn the public about dangerous drugs, it’s often too late for many patients. In the absence of rigorous FDA regulation, common law claims are essential if drug companies are to be accountable to the public. Luckily, given the FDA’s prior view on pre-emption and the legal flaws in its reasoning, its recent statements should not change the legal landscape in any measurable respect. Leslie A. Brueckner and Leslie A. Bailey are attorneys at Trial Lawyers for Public Justice (www.tlpj.org), a national public interest law firm with a special litigation project on fighting federal pre-emption.

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