You may have seen the NY Times Story today.

 

 

            As anyone who reads my blog knows, I have for decades worked at the forefront of dermatology research and drug trials. I also have learned about and shared the experiences of dermatologists abroad who may have obtained access to certain treatments before they were approved in the US and freely shared these valuable clinical insights. My experience has resulted in my becoming a trusted source of information for the press on matters of skin care and beauty. While I have never spoken about the results of a clinical trial outside the halls of science before publication, I have not in the past refrained from discussing foreign clinical experience. The latter statements were the subject of the F.D.A.’s letter to me.

 

According to the New York Times article, “under the Obama administration, the F.D.A. has stepped up scrutiny of drug advertising”. The letter to me makes clear that the F.D.A. will be seeking to restrict all public discussions by clinical investigators of a use of a drug that they may have researched in the past until such drugs become approved for such use. 

 

I applaud the F.D.A.’s focus on the safety and efficacy of drugs, and I have had a lengthy discussion with them about this matter, where I outlined the complexity of applying their rules and suggested some ideas for helping the F.D.A. communicate its views to the medical research community.

 

Because I conduct research on so many drugs, I am in effect held to a higher standard than doctors who do no clinical trials.    This means, of course, that those doctors such as myself who have the most experience with the newest procedures and products will be able to say the least in public about them until FDA approval is issued. Remember this the next time someone touts the “Next New Thing.” To get the educated viewpoint, you will just have to see me as a patient or wait until the F.D.A.’s approval allows the doctors with first-hand scientific experience to address the medical advance.