Well, this is the first Weekly Roundup of the new year – and an exciting year it has been. Since closing out the Where Do the Candidates Stand series, several have dropped out, and there have been surprises. Notably, Senator Clinton, Senator Obama and Senator McCain are all very viable and all favor importation and Medicare Part D Reform.
In the meantime, here is a little of what happened this week:
- Fast Track Comes Under Congressional Scrutiny – Senator Sharrod Brown (D-OH) is questioning whether or not Fast Track authorization is being employed in the manner originally envisioned, according to an article in the Cleveland Plain Dealer.
- FDA Approvals Hit New Low – More reports on low approval figures by FDA – according to an article in the Star-Ledger, the number of new approvals was at 18, with it being lower than that only twice in the past three decades. Meanwhile, the Kaiser Daily Health Policy Report puts the number at 19. Unfortunately in that article, an FDA spokesperson is quoted as saying that they agency has not yet tallied its approvals, which is an odd statement, to say the least.
- People Moving at FDA – Stephen F. Sundlof, D.V.M., Ph.D., is moving from director of FDA’s Center for Veterinary Medicine (CVM) to director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN). Bernadette Dunham, D.V.M., Ph.D., who is deputy director of CVM, will assume directorship of CVM. Robert Brackett, Ph.D., who had been head of CFSAN since 2001 has been appointed Senior Vice President and Chief Science and Regulatory Affairs officer at the Grocery Manufacturers of America.
- FDA Approves New Cialis® Once-Daily Dosing – In case anyone was worried, the FDA has approved a new dosing regimen for Cialis® for erectile dysfunction. According to Lilly’s press release the agency "has approved Cialis® (tadalafil)(1) for once daily use (2.5 mg and 5 mg), an oral medication taken once per day to treat erectile dysfunction (ED). When Cialis for once daily use is taken daily, men can attempt sexual activity at anytime between doses. "
That’s it for this week. Have a good weekend everyone.