March 31, 2014 – The FDA’s recent draft guidance on disseminating reprints, textbooks and clinical practice guidelines (CPGs) discussing off-label uses is a “baby step” forward, Coalition for Healthcare Communication Executive Director John Kamp told The Wall Street Journal (WSJ) last week.
In a March 25 WSJ “Corporate Intelligence” blog post written by former Pharmalot blogger Ed Silverman, Kamp offered a comment on the FDA’s approach to regulating how companies communicate off-label uses to physicians, which can be unnecessarily restrictive and often ignores recent First Amendment court rulings.
“The fact that they’re starting to pay attention and open up off-label communications indicates they know they have to do a better job of defending the limits they have, and specifying what can and can’t be used and how that’s done,” Kamp told Silverman. “There are steps forward here. But in some cases, baby steps.”
The full blog post, which includes additional commentary from Alan Bennett, senior counsel, Ropes & Gray, LLP, Richard Samp, chief counsel at the Washington Legal Foundation, and Arnie Friede, a former FDA chief counsel and former senior corporate counsel at Pfizer, can be viewed here: http://blogs.wsj.com/corporate-intelligence/2014/03/25/fda-clarifies-to-drug-companies-what-can-and-cant-be-said/
Silverman told the Coalition that he soon will be writing a blog on WSJ.com that will continue his coverage of issues and trends in the pharmaceuticals industry. The blog name and launch date have not yet been released. The Pharmalot site went dark at the end of 2013.