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Investigators Can’t Promote Products Before FDA Approval

Investigators Can’t Promote Products Before FDA Approval

The NY Times reported that the FDA has “cracked down” on dermatologist Dr. Leslie Baumann for expressing premature enthusiasm for an anti-wrinkle botulinum toxin product she was studying as an investigator in research trials.1 The FDA’s January 11, 2010, letter to Dr. Baumann cited the following FDA regulation as the basis for its concern about promotional statements she reportedly made in several magazines and on NBC’s Today Show.2 A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug. In question were statements such as these cited below: “…the new Botox, will likely come out later this year. Early data shows it may last longer and kick in faster than Botox. It will be nice to have competition on the market — the Botox people (Allergan) raised their price another 8 percent this year!” “I can’t wait to use Reloxin, known in Europe as Dysport. This Botox alternative will be available in the U.S. next year. Effects last a month longer than Botox and, hopefully, it will cost less.”

What’s the Problem?

The FDA concluded these statements represented that the unapproved product was safe and effective and promoted the drug before FDA approval. The letter went on to say that the statements were misleading, not supported by substantial evidence or clinical experience, and requested that Dr. Baumann inform the FDA of actions “taken or plan to take to prevent similar violations in the future.” The FDA letter raises several issues. First, I’m not sure I would characterize the FDA’s “don’t do it again” action as a “crack down” the way the NY Times did. The FDA didn’t haul Dr. Baumann away in shackles, fine or sanction her in any way, at least as far as I can tell. Let’s not make a mountain out of a molehill. Second, I’m not sure I would agree with the FDA’s interpretation that Dr. Baumann’s statements were misleading or unsupported; I expect that her clinical experience is meaningful, and whether it is or not, I’m not misled into thinking her statements are anything more (or less) than what she thinks based on her experience.

Double Standard for Aesthetic vs. Medical Treatments

Mostly, though, I find the whole episode rather odd. In the (rather prolonged) anticipation of the approval and marketing of the psoriasis drug ustekinumab (Stelara), the first of what we hope will be multiple anti-IL12/23 inhibitors for psoriasis, there seemed to be plenty of talk about the potential of this agent in the dermatology community and in the lay press. I don’t remember the FDA complaining about it. The discussions about anti-IL-12/23 drugs seemed wholly appropriate and valuable, allowing doctors and patients to consider what options may soon be available to them. It is not at all clear to me why the FDA would think that public health would be improved by stifling discussion of products that may soon become available. Maybe there’s a difference between “cosmetic” treatments like a botulinum toxin and a medical treatment for psoriasis. In principle, I’m not sure the difference is all that great.

Balancing Free Speech and Public Health

I appreciate the balancing act in which the FDA frequently finds itself. It has a responsibility to public health, at the same time functioning in a country that cherishes its First Amendment freedom of speech. Sanctioning companies that promote unapproved products is one thing. Trying to muzzle investigators who are reporting their experiences to colleagues or the public seems wholly unnecessary to me.

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