FDA speech oversight
This article was originally published in The Tan Sheet
Executive Summary
Pfizer requests two-month extension of comment period "to formulate the most useful input possible" in response to agency's First Amendment inquiry, according to a June 12 filing. "Locating and analyzing pertinent studies and other professional literature...will be a complex and time-consuming effort," the extension request states. Pfizer also "intends to consult with various experts" to address FDA's questions "more thoroughly and effectively." Pfizer, as well as J&J, PhRMA, suggest July 30 deadline be extended to Sept. 30. FDA is seeking input on nine questions, including the constitutionality of its approach to regulating dietary supplement claims (1"The Tan Sheet" May 20, 2002, p. 6)...