Biotech Values

[DewDiligence]

FDA Internal Memos Could Influence Outcome of Levine v. Wyeth

[“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…”]

http://online.wsj.com/article/SB122529821388980687.html

›FDA Objected to Regulation Moves, Rep. Waxman Says

OCTOBER 29, 2008, 3:54 P.M. ET
By JARED A. FAVOLE

WASHINGTON -- The Food and Drug Administration has enacted a slew of rules to weaken the ability of states to sue drug companies despite objections from top agency officials, according to internal FDA documents released Wednesday by Rep. Henry Waxman.

The documents come just days before the U.S. Supreme Court will hear a key case concerning the right of individuals to sue pharmaceutical companies for products that the FDA has approved.

In 2006, the FDA changed regulation and said it was in favor of pre-emption, the notion that states and individuals should be barred from suing drug companies for products the FDA has approved. And earlier this year, the FDA rewrote drug labeling rules to restrict the ability of companies to disclose new safety risks with prior FDA approval.

Internal FDA documents released by Rep. Waxman, chairman of the House Oversight and Government Reform Committee, show top officials objected to the rules, saying they would harm patients by significantly delaying the addition of important safety information to drug labels.

"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," said John Jenkins, director of the FDA's Office of New Drugs, in a 2003 email. "We know that such an assumption is false."

Mr. Jenkins's comments, as well as those of other FDA officials, were sent to then-FDA chief counsel Dan Troy, who is now general counsel for pharmaceutical giant GlaxoSmithKline Plc.

The documents will likely play into the debate about Wyeth vs. Levine, a case the Supreme Court is scheduled to hear on Monday. In that case, a Vermont guitarist named Diana Levine lost an arm to gangrene caused by an improperly administered nausea drug made by pharmaceutical giant Wyeth.

A Vermont jury awarded her $6.7 million in damages from Wyeth, accepting her argument that the drug maker should have put stronger warnings on the label.

Wyeth said the drug's label was approved by the FDA and said that approval should trump state law on issues of product safety.

The FDA, through the Justice Department, said in briefs before the Supreme Court it is in favor of pre-emption because the agency sets the standards for the drug approval process and approves all product labeling.‹