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Holcombe’s E&C Testimony: PDUFA VI Will Take Patient-focused Drug Development to New Level

March 23, 2017 – In testimony before the House Energy and Commerce Committee’s Subcommittee on Health yesterday, Biotechnology Industry Organization ... read more

Gottlieb Is “Known” Entity to Pharma Industry

March 20, 2017 – Although medical marketers are very familiar with Scott Gottlieb, President Donald Trump’s choice for the top ... read more

Industry Groups Oppose Oregon Bill Calling for Advertising Price Disclosure

March 9, 2017 – Four major advertising and media industry groups have issued a joint letter opposing an Oregon bill ... read more

Trump Needs to Take a Closer Look at FDA Performance

March 8, 2017 – In an open letter to President Donald Trump, Pharmalot’s Ed Silverman asks that before Trump criticizes ... read more

Industry Peacekeeping with President Trump Holds Promise But Portends Danger

By John Kamp, Executive Director, Coalition for Healthcare Communication [Editor’s Note: This “The Final Word” column appeared in the February ... read more

Citizen Petition Calls on FDA to Stay Final Rule Establishing “Totality of the Evidence” Standard for Intended Use

Feb. 24, 2017 – The FDA recently published a final rule on intended use and adequate directions for use that ... 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.