Looking back on the week as it comes to a close, it was an active one. Inside the Beltway, there is a positive obsession with the upcoming elections.
On our front, there have been guilty pleas, drugs approved and all sorts of fun things, so let’s get right down to it:
- PLEA Agreement! – Lester Crawford presided over the FDA during many of the events that led to the erosion of confidence in the agency. This week, reports carried the news that the former Acting Commissioner entered into a plea agreement regarding unclaimed stock ownership and just part of the recent spate of such pleas and admissions simply oozing out of the Washington establishment this season. He will be sentenced in January.
- Approvals Nearly Everywhere – The FDA approved several drugs and new indications this week. Taxotere was approved for head and neck cancer. Taxotere (docetaxel) is manufactured by Sanofi-Aventis, Paris, France. Head and neck cancer represents approximately 3 percent of all new cancer cases in the United States. Aricept, manufactured by Eisai Inc., previously approved for treatment of mild to moderate Alzheimers, is now approved for all stages. Lastly, Merck’s Januvia (sitagliptin phosphate) was approved as a first in class treatment to improve blood sugar levels in patients with type 2 diabetes.
- Speeding Up Generics – CDER announced that it was undertaking a new, speedier approach to approving generics.
- Still No Word on Adaptive Clinical Trials Workshop! Incredible and shortsighted. Will keep you posted.