Citing a crisis within FDA, members of Congress are demanding that the agency withdraw its proposed rule to limit when drug and device manufacturers can revise their product labeling without prior FDA approval.

In a March 3 letter to FDA Commissioner Andrew von Eschenbach, 17 members of the House Oversight and Investigations Subcommittee contend that the agency is unable to review warning label changes fast enough. They say FDA should continue to allow companies to amend their product labels to warn consumers of potential risks "at the earliest possible moment."

In January, FDA issued a proposed rule that would allow companies to alter product labeling without FDA pre-clearance only when new safety information emerges (¹ Also see "FDA Preemption: Agency’s Proposed Labeling Rule Riles Plaintiffs’ Bar" - Pink Sheet, 21 January, 2008., p. 21). Lawyers said the rule would have a significant impact on product liability litigation, bolstering manufacturers' argument that adherence to FDA labeling requirements shields them from personal injury claims.

FDA proposed the labeling rule as the U.S. Supreme Court takes up several cases that address the question of whether federal law preempts state tort claims. Last month the court ruled in favor of preemption in a medical device case. And in a March 3 ruling, it deadlocked in a case dealing with a narrow question of federal preemption in pharmaceutical litigation. Another case is scheduled for review next term.

FDA Lacks Resources For Quick Reviews

Members of Congress meanwhile have sought to rein in FDA pre-emption. In opposing the agency's proposed labeling rule, the members of the oversight subcommittee, led by Chairman Bart Stupak, D-Mich., cite FDA deficiencies that were described at a subcommittee hearing in January (² Also see "Congress Spars With FDA On Budget Figures And Scientific Readiness" - Pink Sheet, 4 February, 2008., p. 6).

"The consensus was clear that the agency suffers from a high turnover rate of scientists, an inadequate information technology system, a weak organizational structure, and a rapidly declining inspection force," they state.

They also point to the decline in FDA enforcement actions in recent years. The number of warning letters issued by the agency for violations of federal requirements dropped more than 50 percent, from 1,154 in 2000 to 535 in 2005.

Agency Is Bypassing FDAAA

Stupak and his colleagues also allude to the issue of FDA pre-emption in product liability litigation. They say they included language in the FDA Amendments Act to strike a balance between giving FDA authority to protect consumers from adverse reactions and "preserving the ability of Americans to pursue common law remedies."

"However," they say, "we believe the FDA's proposed rule directly contradicts this language by reversing a drug manufacturer's obligation to warn of new risks and hazards and, instead, allowing these companies to claim immunity from liability because they had no duty to warn."

Other members of Congress have also voiced opposition to the proposed rule. In January, Rep. Henry Waxman, D-Calif., Sen. Edward Kennedy, D-Mass., and six other leaders of the House and Senate sent a letter to FDA expressing concern that the rule would shield companies from liability for marketing unsafe products (³ 'The Pink Sheet,' Jan. 28, 2008, In Brief).

Kennedy has also said that Congress should consider legislation that would reverse the Supreme Court's decision in February that shields medical device firms from lawsuits. The Riegel v. Medtronic ruling found that the preemption clause in the Medical Device Amendments of 1976 bars suits challenging the safety and efficacy of devices that have received premarket approval by FDA (⁴ Also see "Supreme Court Considers Whether Federal Law Blocks State Drug Tort Claims" - Pink Sheet, 3 March, 2008., p. 13).

"Congress obviously needs to correct the court's decision," Kennedy said in a statement. "Otherwise, FDA approval will become a green light for shoddy practices by manufacturers."

Any serious congressional push on preemption reform will likely await the high court's ruling in Wyeth v. Levine, scheduled for its October term.

Supreme Court Tackles Pre-emption

In the meantime, stakeholders will have to weigh the meaning of deadlock on the first of two drug cases on preemption, Warner-Lambert v. Kent. Given the 8-1 ruling in Riegel, the 4-4 split in Warner-Lambert surprised some observers.

Lawyers involved in the Levine litigation do not believe the Warner-Lambert decision will have any impact on their case as it involves a different issue and takes up preemption in a broader sense.

Chief Justice John Roberts had recused himself from the Warner-Lambert case, leaving eight justices to decide the matter. In a one-sentence ruling, the court said the judgment of the U.S. Court of Appeals for the Second Circuit "is affirmed by an equally divided court."

As a result, it left unanswered the question of whether a Michigan statute specifying when plaintiffs can pursue a tort claim is preempted by federal law.

"My clients won the case but no one won the issue," said Public Citizen attorney Allison Zieve, who argued before the court on behalf of plaintiff respondent Kimberly Kent. "For my clients, it's as if the Supreme Court stage of the case hadn't happened."

At issue was a Michigan statute that shields pharmaceutical companies from product liability suits unless there is evidence the company misrepresented or withheld material information from FDA in obtaining approval of its drug. The question before the court was whether Michigan's exception is impliedly preempted by federal law.

Since there is no majority ruling, no precedent will arise from the decision, said Bert Rein, a partner at Wiley Rein who represented the Pharmaceutical Research and Manufacturers of America in its amicus brief in support of Warner-Lambert.

The plaintiffs are now able to proceed with their suit against Warner-Lambert. They claim the company concealed safety and efficacy information from FDA that would have prevented the diabetes drug Rezulin (troglitazone) from being approved or led to its earlier removal from the market.

- Brenda Sandburg (b.sandburg@elsevier.com)

FDA Preemption Deadlocks Supreme Court; Congress Pushes To Resolve Issue

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