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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

Marketing Tax Provision Escapes Senate Vote

Jan. 13, 2017 – An amendment introduced by Sen. Al Franken (D-Minn.) to eliminate the tax deduction for drug marketing ... read more

FDA Will Study Consumer and HCP Ability to Identify Deceptive Drug Promotion

Jan. 4, 2017 – The FDA will examine whether consumers and health care professionals (HCPs) can identify deceptive claims in ... read more

OPDP Cites Two Companies for YouTube Videos Featuring INDs

Jan. 3, 2017 – In its last blast of 2016, the FDA’s Office of Prescription Drug Promotion (OPDP) sent Untitled ... read more

OPDP Sends Two Letters Citing Major Statement Treatment in TV Ad Claims

Dec. 15, 2016 – Television ads allegedly making false and misleading claims about the risks associated with their products were ... 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.