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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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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 end of 2016, the Office of Prescription Drug Promotion (OPDP) fell short of that goal and apparently will set a very low bar for 2017: It plans to issue only one guidance document in 2017.

According to the Center for Drug Evaluation and Research (CDER) Guidance Agenda for 2017 issued Feb. 17, CDER has committed to issuing a guidance document entitled “Drug and Device Manufacturer Communications with Payors, Formulary Committees and Similar Entities.” The agency announced a draft guidance on this topic on Jan. 19, so it appears OPDP would plan to issue a final guidance on this matter at some point after the comment period on the draft document ends April 19.

This recent announcement leaves in limbo the much-awaited guidance document on off-label/unapproved uses, which industry has been promised for years. The agency held a two-day forum on this issue last November and recently extended the comment period on the topic until April 10; however, without that topic appearing on the guidance agenda for 2017, it remains to be seen whether the agency will act on this topic any time soon.

The Trump administration’s call for regulatory agencies to delete two regulations for every new regulation (which may include guidance documents) could be affecting the agency’s projected plans for 2017 guidance documents. That said, efforts to answer industry’s requests for more guidance on off-label use surely have stalled beyond reasonable expectations.

However, Coalition for Healthcare Communication Executive Director John Kamp noted that “It’s important to not take this report too seriously. New leadership is coming to FDA. The Trump crew will have its own agenda that will likely take hold quickly.”