For better or worse, on November 12 & 13, 2009, the U.S. Food and Drug
Administration and its Division for Drug Marketing Advertising and Communications (DDMAC) will convene a hearing entitled “Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools.”
Sorry, if you didn’t register by October 9, you will not be able to attend in person; however, all are welcome to participate. Healthcare communicators, especially healthcare PR folks, should submit questions and comments to: “Electronic Comments,” identified with docket number FDA-2009-N-0441, at http://www.regulations.gov. Everyone can watch and listen to this hearing for free by registering here.
The hearing will be just that. Be prepared to listen to more than 80 (that’s right, eighty) 15-minute presentations by healthcare communication leaders from industry, academia, government, media and non-profits. And, for one who has endured my fair share of FDA hearings, don’t expect any action, other than the obligatory, “We thank all of you for coming, for your time and thoughtful insights.” “We will take all of your comments under advisement and will continue to compile outside comments and reconvene in 2010.”
We can expect that FDA and DDMAC will float a straw man document for comment in 2010. And, perhaps after another hearing, they might finalize new regulations in 2010. For those of us involved in healthcare communications, healthcare PR and medical communications, these new regs will help us reduce our risk of DDMAC violations. However, it remains to be seen if these new regs will help or hinder industry communication to physicians, patients and caregivers.