Rep. John Dingell will take the lead on healthcare policy for the House Committee on Energy and Commerce under a deal with Rep. Henry Waxman, who unseated Dingell as chairman of the committee last month.
A motion to challenge New Hampshire’s law banning the commercial use of prescriber-identifiable data has been filed by research companies IMS Health and SDI.
Sen. Chuck Grassley (R-IA) today sent letters to Wyeth and a third party regarding Prempro-related journal articles, and specifically the use of ghostwriters, the New York Times reported.
Merck is betting on Democratic plans to speed development of generic biologics, making a play for the market with a new unit tasked with designing the products and promising, in the words of president and CEO Dick Clark, a “new Merck built for the new era that our industry has entered.”
Print and TV ads for ED drugs should appear only in programs or publications with an adult audience of 90% or more under revised PhRMA consumer advertising guidelines — in the original version, released in August 2005, the baseline was 80% — and signatory company CEOs and chief compliance officers must sign an annual certification stating that they have policies and procedures in place to foster compliance with the principles.
Prescription Project: VNRs on YouTube are ads, must include warnings
Drug industry watchdog The Prescription Project called on FDA to take action against video news releases and B-roll for Abbott, Medtronic and Stryker medical devices appearing on YouTube, and said the agency should issue guidance for online ads.
Mirapex promotional violations cited
November 15, 2008
10:18 pm
Two consumer-directed pharmacy printouts and a professionally directed labeling piece for Boehringer-Ingelheim’s Mirapex were considered misleading, according to a warning letter from FDA’s DDMAC.
FDA’s Troy ‘was a pre-emption guru’
November 15, 2008
10:17 pm
The American Association for Justice said federal agency documents it obtained through Freedom of Information Act requests show that former FDA chief counsel Daniel Troy was responsible for the Bush administration’s efforts to pre-empt state liability claims in many federal agencies.
Public Citizen seeks Ortho Evra ban
November 15, 2008
10:16 pm
Ortho-McNeil/Janssen said a Public Citizen petition to the FDA calling for removal of the Ortho Evra contraceptive patch from the market for safety reasons “presents no new information or scientific evidence showing that Ortho Evra is unsafe, ineffective or unnecessary” and should be denied.
Rx safety hasn’t made agency ‘conservative’
November 15, 2008
10:11 pm
The FDA’s director of drug evaluation and research, Janet Woodcock, denied in October that an increased focus on drug safety in recent years, fueled by public and congressional criticism of the agency’s safety oversight, has made her Center more “conservative.”