Internal Documents Indicate Two FDA Officials Objected To Rules Aimed At Pre-Empting Lawsuits

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Litigation / Medical Malpractice
Article Date: 31 Oct 2008 - 7:00 PDT

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Two FDA officials objected to rules recently issued by the agency that sought to limit the ability of consumers to file product liability lawsuits against pharmaceutical companies in state courts, according to internal documents released on Wednesday by House Oversight and Government Reform Committee Chair Henry Waxman (D-Calif.), the Wall Street Journal reports (Mundy, Wall Street Journal, 10/30).

In 2006 and 2008, FDA issued rules that increased agency responsibility for medication labels in support of pre-emption, a legal principle under which federal laws supersede state laws. Supporters maintain that FDA approval of medication labels pre-empts the ability of consumers to file lawsuits against pharmaceutical companies under state product liability laws (Armstrong, CQ HealthBeat, 10/29).

According to the documents, two FDA officials in memos said that FDA approval of medication labels are not completely reliable or based on full disclosure of safety risks by pharmaceutical companies. The "internal documents also revealed that the White House played a significant role in drafting the industry-friendly rules" in support of pre-emption, CongressDaily reports (CongressDaily, 10/29).

Memos
John Jenkins, director of the FDA Office of New Drugs, in a 2003 e-mail wrote, "Much of the argument for why we are proposing to invoke pre-emption seems to be based on a false assumption that the FDA-approved labeling is fully accurate and up-to-date" (Favole, Dow Jones, 10/29). He added, "We know that such an assumption is false" (CQ HealthBeat, 10/29). In addition, he wrote, "It is a gross overstatement of reality" that pharmaceutical companies would disclose all of the safety risks of new medications (Savage, Los Angeles Times, 10/30).

In a 2003 memo, FDA associate director for policy Jane Axelrad wrote, "We rarely find ourselves in situations" in which pharmaceutical companies "want to disclose more risk information than we think is necessary." She added, "To the contrary, we usually find ourselves dealing with situations where sponsors want to minimize the risk information" (Freking, AP/Boston Globe, 10/29). Axelrad also wrote that pre-emption "is not, as it purports to be, consistent with the agency's role in protecting the public health."

The documents likely will prompt Waxman and other congressional Democrats who oppose pre-emption to draft legislation "reversing the Bush administration's pre-emption policy," the Journal reports. Waxman released the documents in advance of a case on the pre-emption that the Supreme Court plans to hear on Monday. The case, Wyeth v. Levine, could determine whether consumers can file product liability lawsuits against pharmaceutical companies in state courts (Wall Street Journal, 10/30).

Comments
Brian Wolfman, director of Litigation Group at Public Citizen, said that the documents are "devastating to the government's case." He added, "They show that the nonpolitical people -- the actual experts in the drug-approval process -- didn't agree with the approach of deferring to the companies."

Alliance for Justice President Nan Aron called the efforts by the Bush administration to "protect powerful corporations from liability at the expense of the safety of American consumers ... unconscionable."

According to a statement released by FDA, "FDA encourages and expects a robust exchange of ideas on matters of public health and public policy." The statement added, "As in any organization, there is rarely unanimity of opinion. In proposing the rules, FDA carefully considered dissenting viewpoints. Many employees of FDA participated in the development and review of the rules" (Los Angeles Times, 10/30).

Levine Profile
USA Today on Thursday profiled Diana Levine, the plaintiff in Wyeth v. Levine, and examined the issue of pre-emption. According to USA Today, the "outcome of the case could affect thousands of potential lawsuits by consumers against drug companies each year" (Appleby, USA Today, 10/30).

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