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Pharmas eagerly await FDA guidance on social media

Thursday, April 7, 2011

As the FDA further delays its eagerly-awaited draft guidance on social media, U.S. drugmakers have pointed to the “incredible potential public health benefits” of using electronic media in health care, according to Pharma Times.

These include “allowing innovative companies to provide truthful, scientifically-accurate FDA-regulated information,” says Jeffrey Francer, assistant general counsel at the Pharmaceutical Research and Manufacturers of America (PhRMA).

The FDA had planned to issue its Draft Guidance on the Internet and Social Media last December: when that deadline passed, the goal was during the first quarter of 2011.  The  draft guidance was to address at least one of the following topics: responding to unsolicited requests; fulfilling regulatory requirements when using tools associated with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; and use of links on the Internet and correcting misinformation.

Now, the FDA said that it is developing multiple draft documents on a number of issues, and “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 (GGPs),” which ensure that that the agency’s stakeholders are provided with “well-vetted guidances articulating FDA’s current thinking on a topic.”

Pharmaceutical companies are anxious to receive the agency documents, noting that the only guidance they receive now comes in the form of warning letters, but they are also concerned that any further delays could leave them motionless as the technology moves further on.

PhRMA has engaged the agency in public discussion of how its member companies can appropriately communicate with health care providers and patients on-line, “using the same tools as the FDA and the White House, including Twitter, Facebook and blogs,” said Mr Francer.

The industry group has proposed “responsible means to provide safety information in space-restricted media, including a universal symbol that could help lead patients to web sites that feature FDA-regulated benefit and risk information about new medicines,” he said, and added: “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.”

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