Looks to me like the Merck guy is not the author,

Looks to me like the Merck guy is not the author, but someone who cleared it. The comments don't say anything about the background or affinities of the author, the Associate Director for Policy (Acting) in the Office of New Drug Policy.

Peter Stein is the Director or the office of New Drugs, and yes, he was with Merck. So far I can't find "the Associate Director for Policy in the Office of New Drug Policy." But clearly it's not Stein.

Quote:

---

1. Associate Director for Policy (Acting) in the Office of New Drug Policy;
a. Comments: This person was also the author of this statement!
2. Director of the Office of Infectious Diseases. As part of this clearance, the Statement also was reviewed by a division director, deputy division director, a clinical team leader, and a clinical reviewer within this division.
3. Director of the Office of New Drugs
Comments: Before coming to FDA, he served as Vice President for late-stage development, diabetes, and endocrinology at Merck Research Laboratories. He also served as Vice President, head of metabolism development at Janssen.

---