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Thursday, January 19, 2006

Law - FDA Tries to Limit Drug Suits in State Courts [Updated]

"FDA Tries to Limit Drug Suits in State Courts: Agency's 'Federal Preemption' Policy Included in Labeling Guidelines for Medications," is the headline to this lengthy story today in the Washington Post. Some quotes:

People who believe they were injured by drugs approved by the Food and Drug Administration should not be allowed to sue drug companies in state courts, the agency said yesterday in a formal policy statement.

The FDA's controversial assertion of "federal preemption" was included as a preamble to long-awaited guidelines designed to make drug labeling information more accessible and readable for doctors and consumers. Agency officials said that though the preemption policy does not have the weight of law or formal regulation, they hope state judges will accept their position. [my emphasis]

Included in a preamble?

For more information, see the 1/18/06 FDA press release here. The bottom of the page includes links to the rule, which has not yet been published in the Federal Register. The rule is in three very large (about 9MB each) parts, because it is scanned. Part 1 includes the preamble language discussed in the Post story; look at the discussion on pages 38-47.

[Updated 1/26/06]
The 1/19/06 NY Times had an article titled "New Drug Label Rule Is Intended to Reduce Medical Errors" that included this:

Trial lawyers reacted angrily to a preamble to the new rule stating that the rule pre-empts, or supersedes, state liability statutes.

In the preamble, the agency listed six claims against drug makers that would be prohibited as a result of the rule, including claims that a drug maker should have put into a label's ''highlights'' section a risk warning included elsewhere in its label, or claims that a drug maker should have included a warning that the drug agency deemed unnecessary.

''Overwarning, just like underwarning, can similarly have a negative effect on patient safety and public health,'' the preamble states.

Drug agency officials have for years made similar arguments in some product liability trials, but the preamble may provide broader protections to drug makers, former agency lawyers said.

''It will make it impossible to file liability claims,'' said Peter Barton Hutt, a former general counsel for the agency who is in private practice. Other lawyers suggested that the preamble would provide far less protection to drug makers.

Representative Maurice D. Hinchey, Democrat of New York, said that the liability provisions of the new rule showed that the drug agency ''has once again gone to bat for the drug industry.''

Chris Mather, a spokeswoman for the Association of Trial Lawyers of America, called the preamble ''the scariest example yet of how much power drug makers have in our political process.'' Ms. Mather said that the drug agency did not have the authority to issue such a waiver.

Drug labels had become confusing for several reasons, said Dr. Janet Woodcock, deputy commissioner of the agency. First, liability and marketing concerns had gradually displaced physician education as the principal focus of label writers, Dr. Woodcock said. Second, far more is known now about how drugs work in the body than was the case 20 or 30 years ago, and much of that information has to be included in drug labels, she added.

And third, ''There are more drugs than ever, and physicians have less time than ever in every patient encounter,'' Dr. Woodcock said.

The new label rule will apply to all new drug approvals, to drugs approved within the past five years, and to any drug for which a major label revision is requested. Older drugs can avoid the requirements, although Dr. Woodcock said that doctors were often already far more familiar with the risks and benefits of older medicines.

Posted by Marcia Oddi on January 19, 2006 03:24 PM
Posted to General Law Related