FDA won't deliver on social media rules

Once again, the FDA fails to meet a deadline. This time, it's the promised guidelines on using the Internet and social media for marketing--the guidelines that drugmakers have been anxiously awaiting...even demanding--for years now.

The agency gathered suggestions this year, including a two-day hearing during which everyone from Google to Novartis presented their hopes and fears about regulatory oversight of pharma's online activities. The FDA pledged to deliver draft guidelines by year's end. As Pharmalot reports, that's not going to happen, the agency says.

Apparently, the world of online and social media has proven too broad a target. The agency has broken that world into bite-sized topics, such as "fulfilling regulatory requirements when using tools associated with space limitations" and "online communications for which manufacturers are accountable" and "responding to unsolicited requests." And it plans to release one draft guidance that deals with at least one of these topics during the first quarter of next year.

- read the Pharmalot post

Suggested Articles

Esperion's Nexletol has had a rough road to approval after safety concerns nearly derailed its quest. But an FDA nod has the drug ready for market.

In an interview with Israel's Calcalist, Teva CEO Kåre Schultz shared details of his approach to the company's turnaround.

Nerlynx is already struggling in its extended adjuvant breast cancer setting, and new entrants from Daiichi-AZ and SeaGen could pressure it elsewhere.