FDA Actions Against Off-Label Reprints violate appellate court decision, Washington Legal Foundation says in May 23 citizen petition. Foundation might sue FDA again if it doesn't receive a favorable response. Group cites FDA letter to Wyeth concerning Protonix journal article reprint distribution. National Abortion Federation Mifepristone Public Service Ad is similar to Danco's Mifeprex ad in medical journals, except for safety information. Danco promotion also includes direct mailing to providers.
Guidelines advise ads to present balanced information and to discuss alternative treatments.
Sanofi Plavix Vs. Aspirin Promotion Citation is received via a second letter from FDA's ad division objecting to superiority claims. Elan Verelan Manufacturing Consent Decree follows two warning letters from FDA in 1995 and 1998, as well as an inspection during summer 2000. FDA is not requiring product recall or financial settlement. FDA cites pattern of good manufacturing practices violations over six year period.