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FDA delays social media guidance again

The US Food and Drug Administration has again delayed draft guidance on social media, citing the complicated nature of the issue and the limited time and money at its disposal

The US Food and Drug Administration (FDA) has again delayed its much-anticipated draft guidance on social media. The agency said it will not release the guidance this quarter as planned, citing the complicated nature of the issue and the limited time and money at its disposal.

The delay comes at the same time as the UK's Prescription Medicines Code of Practice Authority (PMCPA) announced the publication of 'informal guidance' on digital communications, with advice on how the pharmaceutical industry in the UK can use online communications.

The FDA declined to provide a new target date for the release of the draft guidance. "It is difficult to provide a timeframe for the issuance of our guidances due to the extensive work and review process, or 'Good Guidance Practices', which ensures that FDA's stakeholders are provided well vetted guidances articulating FDA's current thinking on a topic," according to a statement from the agency.

The FDA had originally been set to release the draft guidance in December 2010, but at that time said it was postponing publishing the document until the second quarter of this year.

However, despite the delays, the agency maintained in the new statement that the draft guidance is among its "highest priorities," adding: "Despite our limited resources and increasing workload, we remain committed to this area in terms of both time and human resources."

The FDA noted that it is actually developing multiple draft guidances, rather than just one, focused on six topics that it has identified as being the key issues.

The six topics that the guidances will address are: responding to unsolicited requests; fulfilling regulatory requirements when using tools associated with space limitations; fulfilling post-marketing submission requirements; on-line communications for which manufacturers, packers, or distributors are accountable; use of links on the Internet; and correcting misinformation.

Pharmaceutical Research and Manufacturers of America (PhRMA) assistant general counsel Jeffrey K Francer responded to the new delay with a moderate statement encouraging the agency to draw up the guidelines and reiterating the trade group's belief in the importance of social media as a communications tool for the pharma industry.

"As PhRMA eagerly awaits the FDA's guidance on this important issue, we note that FDA itself is making almost daily use of Twitter, Facebook and other social media," Francer said. "There are incredible potential public health benefits to using electronic media in healthcare, including allowing innovative companies to provide truthful, scientifically accurate FDA-regulated information."

4th April 2011

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