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. FDA's May 21 Talk Paper on Elan's consent decree.
Improved performance is attributed to effort to increase chemistry review staff.
FDA Prescription Drug User Fee Act Update increases Congressional pressure to reauthorize program ahead of sunset date. Agency doubles projected spending of carry-over balance over next two years as spending rises while revenues fall. Drug center expects to hire 280 full time equivalents over five years. FDA's 2001 five-year plan update for the Prescription Drug User Fee program. FDA Acting Senior Advisor For Science will be veterinary center research director Norris Alderson.