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A Federal Rule About Prescription Drug Label Inserts

FDA Rule Would Preempt Stricter State Laws

WASHINGTON, DC -- January 27, 2006 -- A federal rule about prescription drug labeling attempts to preempt stricter state labeling laws. Drafted by the federal Food and Drug Administration (FDA), the new rule makes label inserts more uniform and easier to understand, according to the agency. However, consumer groups charge that the rule would allow drug companies to escape liability for failure to warn about a drug's dangers as long as it met minimum federal labeling standards. The state protections against companies that make unsafe drugs such as Vioxx® would be weakened, they say.

The FDA rule was first issued as a proposal in December, 2000. It is now scheduled to go into effect on June 30, 2006, after laying dormant for over five years. The language allowing the preemption of state labeling laws was added at the last minute, without debate and a proper public comment period, according to consumer groups. In fact, in 2000, the FDA assured the public that the "proposed rule does not preempt state law" (Notice of Proposed Rulemaking, Fed. Reg. Vol. 65, No. 247, p. 81103).

"The Food and Drug Administration is attempting a back-door approach to preempt state prescription drug product liability laws despite Congress and the courts' refusal to grant them such power," said the National Conference of State Legislatures (NCSL), a bipartisan group providing research to state legislators and their staffs (Press Release, January 13, 2006). The organization sent a letter of protest to the FDA stating: "It is unacceptable that the FDA would not permit the states to be heard on language that has a direct impact on state civil justice systems nationwide."

"This is a sneak attack on consumer rights," said Joan Claybrook, President of the consumer group, Public Citizen (Press Release, January 18, 2006). "President Bush is once again abusing his executive powers, this time in his attempt to protect the big pharmaceutical companies from the consequences of their actions. Thousands of people in this country have died or been seriously injured by drugs approved by the FDA, and this administration is saying it doesn't think people should have any recourse."

Public Citizen commented that the new rule does simplify and prioritize drug information on the label insert, but patients continue to rely on patient information leaflets whose content is not carefully reviewed by the FDA. About half of these leaflets are inadequate, according to Public Citizen, because they lack correct and complete guidance about drug side effects and interactions.

Information About Unsafe Prescription Drugs

For the full text of the final FDA rule, see FDA News, January 18, 2006, scroll to "Final Rule: Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products," which is near the bottom of the page. Links to the files containing the final rule are listed below this heading. You will need a copy of Adobe Acrobat Reader to open these files. If you do not already have this software, you may download a free copy at the Adobe Acrobat web site.

At Brayton Purcell, we are concerned about medical problems caused by unsafe or ineffective prescription drugs. If you have been injured by a prescription drug, please feel free to contact us to learn about your legal options. We have been fighting for the rights of consumers for over 20 years and are well-versed in medical/legal issues.

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