Food & Drug Bulletin

Dear Reader:

FDA is having a streak of bad luck in the courts as illustrated by three recent deci-sions. As reported herein, on January 15 of this year, the U.S. Court of Appeals for the DC Circuit found that FDA rules barring certain health claims to be invalid under the First Amendment. In a landmark ruling, the court ordered FDA to change its health claim rules for dietary supplements. Shortly after, the U.S. District Court in Utah declared Cholestin to be a dietary supplement and not a new drug, as alleged by FDA. The ruling, which FDA may appeal, confirms that "articles approved as new drugs" refers to finished drug products and not unrefined dietary supplement com-ponents. On the same day, D.C. federal court Judge Royce Lambeth declared that FDA policy and guidance documents on dissemination of off-label claims in refer-ence books and journal articles are uncon-stitutional. Judge Lambeth further reasoned that if the policies underlying the FDAMA provisions are the same as those previously declared unconstitutional, the FDAMA provisions may also be unconstitu-tional. FDA appears to be losing the peren-nial tug-of-war with industry at the moment but with a new Commissioner and a change in Congress, the situation is still fluid and worth watching closely.

Sincerely,

Articles In This Issue

McKenna & Cuneo Attorneys Receive Distinguished Awards

Court Orders FDA To Revise Health Claims Rules For Dietary Supplements

CDRH Director Bruce Burlington, M.D. Resigns

FDA Office Of Generic Drugs Informs Generic Drug Industry Of Its Financial Disclosure Responsibility

FDA Issues Final Rule Amending Clinical Hold Regulations

FDA Announces Availability Of Expedited Review Process For Certain Food Additive Petitions

FDA Announces Pilot Customer Satisfaction Survey For Medical Device Inspections

The European Commission Proposes To Extend The Date For Sole Use Of The Metric System To 2009

International Trade Commission Seeks Advice Concerning The Addition Of Pharmaceutical Products To The U.S. Harmonized Tariff Schedule

Federal Court Issues Additional Ruling Concerning FDA's Off-Label Information Dissemination Policy

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