Category: Courts/First Amendment

Courts/First Amendment

Kamp to Washington Post: Companies Should Be Able to Speak Truthfully About Drugs

July 14, 2014 – Drug companies should be allowed to share truthful information about the off-label uses of their drugs, Coalition for Healthcare Communication Executive Director John Kamp told The Washington Post last week. In the July 9 article, “FDA has free-speech, safety issues to weigh in review of ‘off-label’ drug marketing rules,” Kamp and […]

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New FDA Social Media Guidances Address Space-limited Media, Correcting Online Misinformation

June 23, 2014 – Although the two social media draft guidance documents the FDA’s Office of Prescription Drug Promotion (OPDP) issued June 17 do not exactly establish any new marketing policy, they do help industry to understand what is expected by the agency in several online forums, according to Coalition for Healthcare Communication Executive Director […]

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CHC Comment to FDA: Less Is More in DTC TV Ads

May 2, 2014 – The Coalition for Healthcare Communication believes that “shorter, simpler disclosures are most likely to lead to robust doctor-patient conversations and better health outcomes,” according to a comment the CHC submitted to the FDA today on its proposal to conduct research on the impact of limiting risks presented in direct-to-consumer (DTC) prescription […]

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FDA Willing to “Re-examine” Off-label Policies in Light of First Amendment Rulings

April 28, 2014 – The FDA is not taking lightly industry’s concerns that its existing off-label policies are not in line with the most recent First Amendment case law, according to FDA senior officials who spoke recently at the Food and Drug Law Institute’s Annual Meeting held in Washington, D.C. On April 23, Leslie Kux, […]

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Kamp to WSJ: FDA Could Do a Better Job of Defending Off-label Limits

March 31, 2014 – The FDA’s recent draft guidance on disseminating reprints, textbooks and clinical practice guidelines (CPGs) discussing off-label uses is a “baby step” forward, Coalition for Healthcare Communication Executive Director John Kamp told The Wall Street Journal (WSJ) last week. In a March 25 WSJ “Corporate Intelligence” blog post written by former Pharmalot […]

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CHC Briefing to Provide Medical Marketers With Preview of How Washington Will Affect Their 2014

Jan. 8, 2014 – At a Jan. 16 Coalition for Healthcare Communication breakfast briefing to be held in New York City, medical marketers will hear from “inside the Beltway” experts about how federal policies and politics are likely to shape the coming year. The meeting, free to Coalition members and prospective members, will feature keynote […]

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Kamp on Off-label Discussion at the CMS/FDA Summit

Jan. 3, 2014 – From Coalition for Healthcare Communication Executive Director John Kamp: Several weeks ago I was privileged to participate in this year’s CMS/FDA Summit, produced by the editors of The RPM Report. Among the most interesting panel presentations was that titled “Beyond the Label,” featuring Mit Spears, General Counsel of the Pharmaceutical Research […]

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Update: Supreme Court Decision Ends Presumption in Favor of “Pay for Delay” Agreements

June 17, 2013 – In a 5-3 decision announced today, the U.S. Supreme Court ended the legal presumption that “pay for delay” agreements among branded and generic drug companies are legal. The decision will allow the Federal Trade Commission to challenge and block these agreements when it finds them to reduce competition from other generic drug […]

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