Digitas: FDA Warning to Novartis Over Facebook Post Contains Upside
Peter Pitts has more analysis in his blog at www.drugwonks.com
Please read, then come back here to comment.
FDA Watch: There’s More to the New DDMAC Than Just a New Name
Coalition Executive Director John Kamp wrote this OpEd piece published on March 15th by MM&M.
If you or your clients have sent promotion materials to FDA recently for prepublication review, or have been the recipient of a DDMAC Warning Letter, you know that FDA’s DDMAC has assumed a very aggressive enforcement posture.
Peter Pitts Tells Why FDA DDMAC Letter to Bauman Isn’t a First Amendment Issue
From Peter Pitts:
Much brouhaha about the DDMAC letter sent to Dr. Leslie Bauman about her enthusiastic comments about a yet-to-be-approved anti wrinkle injectable.
At first blush, this seems like regulatory creep and cause for First Amendment agita. But it isn’t. This is not a case of the FDA trying to stifle unregulated speech by an individual without “interest.” Dr. Bauman is a clinical investigator for the product she’s been touting. That’s “interest” whether the trial sponsor paid her to do so or not. (In this instance, there was no “pay for play.”) In any case, it’s an unambiguous regulatory no-no.
Your comments are welcome here.
CEI Report Says FDA-DDMAC Policy Could Restrict Information for Patients
From Competitive Enterprise Institute (CEI):
A new CEI analysis cautions that FDA’s current policy restricting use of Internet sponsored links could have the unintended effect of making regulated information less available to consumers and making less reliable and unsubstantiated information more available.
Results 11-14 of 14
- 1
- 2
Recent Comments