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OPDP Plans Just One Guidance Document for 2017

Feb. 20, 2017 – Although the FDA announced last August that it would issue four advertising-related guidance documents by the ... read more

Kamp: Buckle Up for a Bumpy Ride with Trump

Coalition Commentary by Executive Director John Kamp Feb. 6, 2017 — Fasten your seatbelts and put your tray tables in ... read more

Draft Guidance Covers How to Keep Communications Consistent with FDA Labeling

Jan. 27, 2017 – The FDA issued draft guidance last week that is designed to help medical product  manufacturers understand ... read more

FDA Issues Draft Guidance on Payor Communications

Jan. 27, 2017 – The FDA recently announced the availability of draft guidance for industry covering manufacturer communications with payors ... read more

New Memorandum Spells Out FDA’s First Amendment Position on Off-label Use Promotion

Jan. 20, 2017 – The FDA effectively delayed any prompt action on new guidance covering the promotion of unapproved or ... read more

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Federal Appeals Court Reverses Conviction of Detailer for “Off-label” Promotion

Regulation of Pharma Speaker’s Truthful Message Violates the First Amendment

Dec. 3, 2012 – The U.S. Court of Appeals for the Second Circuit released a long-awaited decision today reversing the conviction of Alfred Caronia, a detailer for Orphan Medical Inc., who admitted that he intentionally promoted Xyrem for uses not approved by the FDA. The decision relies heavily on the reasoning of the recent Supreme Court decision in IMS v. Sorrell, to find that FDA-related regulation of truthful speech by drug companies must meet the exacting standards of the First Amendment.

“Although the FDA can continue to regulate false and misleading marketing by regulated companies, this decision likely will force serious reassessment of label-based restriction,” said John Kamp, Executive Director of the Coalition for Healthcare Communication. “While medical marketers must continue to comply with existing law, policymakers and lawyers throughout our community will be busy reviewing this decision and an inevitable appeal to the Supreme Court,” Kamp stated.