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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Draft Guidance Covers How to Keep Communications Consistent with FDA Labeling

Jan. 27, 2017 – The FDA issued draft guidance last week that is designed to help medical product  manufacturers understand ...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FDA Issues Draft Guidance on Payor Communications

Jan. 27, 2017 – The FDA recently announced the availability of draft guidance for industry covering manufacturer communications with payors ...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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Coalition’s Role

The Coalition’s role is first, to defend the rights of medical professionals and consumers to receive appropriate healthcare information, and second, to act to prevent or reverse actions interfering with the free flow of healthcare information.

Whenever open communication regarding a pharmaceutical or medical product is obstructed, the Coalition proactively explores ways to break down barriers. Issues are raised and discussed in depth at regular executive monthly committee meetings, typically held in New York City. Subcommittees are often formed to research specific topics and propose solutions to the larger group.

Once the Coalition thoroughly investigates an issue, it formulates a position that reflects the concerns and desires of its member organizations. Often, it seeks input from other important authoritative bodies.