The issue relates both to the primacy or otherwise of state laws in liability claims and the extent of manufacturers' own obligation to inform doctors and patients about any potential new risks associated with their products. It also echoes two pharmaceutical product liability cases set to come before the US Supreme Court this year (Warner-Lambert v. Kent and Wyeth v. Levine), as well as a medical device case already argued and awaiting the Supreme Court's opinion (Riegal v. Medtronic). Federal pre-emption of state law is pivotal to these cases and, as a brief from lawyers McDermott Will & Emery points out, in all of them "the Solicitor General, on FDA's behalf, has weighed in strongly in favour of pre-emption". The main point of contention with the agency's proposed rule on Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices - and what has both trial lawyers and Congressional Democrats, who see the heavy hand of the Bush administration, up in arms - is its relatively narrow definition of circumstances in which manufacturers may unilaterally make amendments to product labelling through a "changes being effected" (CBE) supplement, in advance of the FDA reviewing and approving these changes. The provision has been invoked by plaintiffs in product liability cases, who argue that failure to warn of potential new adverse effects through this procedure exposes manufacturers to tort liability under state law. For their part, the manufacturers typically contend that their ability to make unilateral labelling changes is strictly circumscribed, and that product liability claims based on a 'failure to warn' are pre-empted by FDA approval of the existing labelling. The agency also took this position in the preamble to its January 2006 Final Rule on Requirements on the Content and Format of Labeling for Human Prescription Drug and Biological Products, which expresses the FDA's belief that "under existing preemption principles, FDA approval of labeling under the [Federal Food, Drug, and Cosmetic Act], whether it be in the old or new [labelling] format, preempts conflicting or contrary State law". The final labelling rule goes on to warn that, given "the comprehensiveness of FDA regulation of drug safety, effectiveness, and labeling under the act, additional requirements for the disclosure of risk information are not necessarily more protective of patients." "Instead, they can erode and disrupt the careful and truthful representation of benefits and risks that prescribers need to make appropriate judgments about drug use. Exaggeration of risk could discourage appropriate use of a beneficial drug." This argument is effectively reiterated in the proposed rule on CBE supplements. The agency also insists the proposed rule is designed merely to "codify [its] longstanding view on when a change to the labeling of an approved drug, biologic, or medical device may be made in advance of the agency's review and approval of such change". For the FDA's critics, though, the proposals are just further evidence that the agency has caved in to pressure from Big Pharma and its allies in the Bush administration. The American Association for Justice (AAJ), which represents trial lawyers, demanded that the FDA "withdraw a proposed rule that would allow drug companies to claim immunity for failing to warn patients of potential drug hazards". Under the current proposals, it noted, manufacturers would only have to update their labelling (i.e., without FDA pre-approval) "after they establish a 'causal association' between the drug and the hazard, which could take years". "With this rule the FDA thumbs its nose at Congress, and leaves patients in the dark about the safety of the prescriptions they are given," said AAJ president Kathleen Flynn Petersen. A letter sent to FDA Commissioner Dr Andrew von Eschenbach by eight Congressional Democrats, including committee chairmen Henry Waxman, Edward Kennedy and John Dingell, was no less scathing. "At a time when the FDA lacks the resources to adequately protect Americans from unsafe drugs and devices, it is astonishing that the Bush Administration has opted to dedicate FDA's strained resources to protecting the drug and device industry from liability for marketing dangerous products," it states. "The 26-page CBE proposal has no purpose other than to shore up the industry's legal arguments for avoiding liability". Other, less hostile commentators claim the suggestion of political interference is pure opportunism, as the debate over pre-emption predated the current US administration. The crux of the "longstanding position" set out by the FDA in its proposed rule is that CBE supplements "were intended as a narrow exception to the general rule that labeling changes require FDA approval". Accordingly, the agency argues that the labelling supplements should only be used in the case of "newly acquired" safety information. It defines this as "data, analyses, or other information not previously submitted to the agency, or submitted within a reasonable time period prior to the CBE supplement, that provides novel information about the product, such as a risk that is different in type or severity than previously known risks about the product". Moreover, the proposed rule states, a CBE supplement may only be used to make labelling changes relating to contraindications, warnings, precautions or adverse reactions "in circumstances where there is sufficient evidence of a causal association with the drug, biologic or medical device". The FDA also re-affirms its stance on pre-emption. Under a section on Federalism, the proposed rule comments: "To the extent that state law would require a sponsor to add information to the labeling for an approved drug or biologic without advance FDA approval based on information or data as to risks that are similar in type or severity to those previously submitted to the FDA, or based on information or data that does not provide sufficient evidence of a causal association with the product, such a state requirement would conflict with federal law." In these situations, the FDA says, "it would be impossible to market a product in compliance with both federal and state law, and the state law would "stand[] as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress," Hines, 312 U.S. at 67". The deadline for comments on the proposed rule is 17 March 2008.
