Healthcare blogger Peter Pitts (Drug Wonks) wrote a clarifying piece, which begins:
"Much brouhaha about the DDMAC letter sent to Dr. Leslie Bauman about her, um, 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."
Click to read more. Your comments are welcome here.
"Much brouhaha about the DDMAC letter sent to Dr. Leslie Bauman about her, um, 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."
Click to read more. Your comments are welcome here.
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