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Whether it be botulinum toxin, a new drug, or a miracle wrinkle cream, we've all heard clinical investigators tout "their" investigational product as the next best thing since penicillin at medical meetings--usually with full disclosure. I'll also bet that you can recall a number of instances where you've turned on the T.V. or radio to hear physicians promoting an investigational drug or device they are intimately connected to.
So does the Jan. 11 Division of Drug Marketing, Advertising, and Communications' letter to Dr. Leslie S. Baumann signify an FDA crackdown?
The agency cited Dr. Baumann for suggesting that Ipsen's Dysport (abobotulinumA) is superior to Allergan's Botox (onabotulinumtoxinA) in Allure and Elle magazine, and on the "Today Show" on NBC before the approval of Dysport. The letter said that Dr. Baumann suggested that Dysport was "safe and effective before it was approved, and that it was in fact superior to the approved product Botox." According to the FDA, no head-to-head trials of Botox to Dysport have been conducted to assess this.
Dr. Baumann became a clinical investigator for Dysport in July 2006, according to the FDA letter. While she was a trial investigator, she made one such comment to Allure: "Reloxin, the new Botox, will likely come out later this year. Early data show it may last longer and kick in faster than Botox."
This, according to the FDA, was a promotion of an unapproved drug, and against regulations that state "A sponsor or investigator ... shall not represent in a promotional context that an investigational new drug is safe and effective for the purposes for which it is under investigation or otherwise promote the drug."
Dr. Baumann was given 10 business days from the receipt of the letter to inform the FDA of the actions she plans to take to "prevent similar violations in the future."
I spoke with Dr. Baumann, a Skin & Allergy News editorial advisory board member and columnist, today about this matter, but she was unable to comment for now. UPDATE: Dr. Baumann addressed the FDA letter on her blog at Skin Type Solutions on Feb. 1.
She is in private practice in Miami, but was with the University of Miami when she conducted the clinical trials for Medicis. (Ipsen granted Medicis Pharma the rights to develop, distribute, and commercialize Dysport.)
This is another example of why clinical trial investigators should disclose, disclose, disclose! The bottom line: don't promote until approved!
Whether it be botulinum toxin, a new drug, or a miracle wrinkle cream, we've all heard clinical investigators tout "their" investigational product as the next best thing since penicillin at medical meetings--usually with full disclosure. I'll also bet that you can recall a number of instances where you've turned on the T.V. or radio to hear physicians promoting an investigational drug or device they are intimately connected to.
So does the Jan. 11 Division of Drug Marketing, Advertising, and Communications' letter to Dr. Leslie S. Baumann signify an FDA crackdown?
The agency cited Dr. Baumann for suggesting that Ipsen's Dysport (abobotulinumA) is superior to Allergan's Botox (onabotulinumtoxinA) in Allure and Elle magazine, and on the "Today Show" on NBC before the approval of Dysport. The letter said that Dr. Baumann suggested that Dysport was "safe and effective before it was approved, and that it was in fact superior to the approved product Botox." According to the FDA, no head-to-head trials of Botox to Dysport have been conducted to assess this.
Dr. Baumann became a clinical investigator for Dysport in July 2006, according to the FDA letter. While she was a trial investigator, she made one such comment to Allure: "Reloxin, the new Botox, will likely come out later this year. Early data show it may last longer and kick in faster than Botox."
This, according to the FDA, was a promotion of an unapproved drug, and against regulations that state "A sponsor or investigator ... shall not represent in a promotional context that an investigational new drug is safe and effective for the purposes for which it is under investigation or otherwise promote the drug."
Dr. Baumann was given 10 business days from the receipt of the letter to inform the FDA of the actions she plans to take to "prevent similar violations in the future."
I spoke with Dr. Baumann, a Skin & Allergy News editorial advisory board member and columnist, today about this matter, but she was unable to comment for now. UPDATE: Dr. Baumann addressed the FDA letter on her blog at Skin Type Solutions on Feb. 1.
She is in private practice in Miami, but was with the University of Miami when she conducted the clinical trials for Medicis. (Ipsen granted Medicis Pharma the rights to develop, distribute, and commercialize Dysport.)
This is another example of why clinical trial investigators should disclose, disclose, disclose! The bottom line: don't promote until approved!
Whether it be botulinum toxin, a new drug, or a miracle wrinkle cream, we've all heard clinical investigators tout "their" investigational product as the next best thing since penicillin at medical meetings--usually with full disclosure. I'll also bet that you can recall a number of instances where you've turned on the T.V. or radio to hear physicians promoting an investigational drug or device they are intimately connected to.
So does the Jan. 11 Division of Drug Marketing, Advertising, and Communications' letter to Dr. Leslie S. Baumann signify an FDA crackdown?
The agency cited Dr. Baumann for suggesting that Ipsen's Dysport (abobotulinumA) is superior to Allergan's Botox (onabotulinumtoxinA) in Allure and Elle magazine, and on the "Today Show" on NBC before the approval of Dysport. The letter said that Dr. Baumann suggested that Dysport was "safe and effective before it was approved, and that it was in fact superior to the approved product Botox." According to the FDA, no head-to-head trials of Botox to Dysport have been conducted to assess this.
Dr. Baumann became a clinical investigator for Dysport in July 2006, according to the FDA letter. While she was a trial investigator, she made one such comment to Allure: "Reloxin, the new Botox, will likely come out later this year. Early data show it may last longer and kick in faster than Botox."
This, according to the FDA, was a promotion of an unapproved drug, and against regulations that state "A sponsor or investigator ... shall not represent in a promotional context that an investigational new drug is safe and effective for the purposes for which it is under investigation or otherwise promote the drug."
Dr. Baumann was given 10 business days from the receipt of the letter to inform the FDA of the actions she plans to take to "prevent similar violations in the future."
I spoke with Dr. Baumann, a Skin & Allergy News editorial advisory board member and columnist, today about this matter, but she was unable to comment for now. UPDATE: Dr. Baumann addressed the FDA letter on her blog at Skin Type Solutions on Feb. 1.
She is in private practice in Miami, but was with the University of Miami when she conducted the clinical trials for Medicis. (Ipsen granted Medicis Pharma the rights to develop, distribute, and commercialize Dysport.)
This is another example of why clinical trial investigators should disclose, disclose, disclose! The bottom line: don't promote until approved!