Well, as the sun sets on our week, it is time for the Weekly Roundup. So much has happened, my head is practically spinning.
I don’t know about the rest of you, but for me it has been a long week. The summer stretches out with unrelenting heat and furious storms, the mosquitoes are pesky, the garden overtaken with weeds, the lawn too long, but the lemonade is homemade and good and I look forward to the thought of a mint julep at least once this summer. The longest day of the year has passed and we are headed to the shortest…. And to mark its passage, here’s the news of the week.
- Adaptive Clinical Trial Design FDA Meeting – Since my posting about this, I’ve gotten a LOT of inquiries about the date and place. They have not yet been announced. As soon as I know something I will post it here, but it sounds like there is a great deal of interest in this meeting.
- FDA Offers Senate Testimony on Speeding Generic Drug Approvals – Dr. Gary Buehler offered testimony before the Special Committee on Aging in the Senate last week. He explained how Hatch-Waxman works, which I guess was to provide context for the spectators. He cited the increased number of generic applications before the agency, having increased 150% over 5 years while the budget has increased only 66% (See posting of two days ago about FDA mandates and the Kennedy/Enzi bill). While facing a backlog, the good news is that they have nevertheless generated an increase in application processing. Some of his points, like the budget were quite interesting. Others – about using the telephone instead of letters to communicate with companies and assigning applications to those with expertise – were not exceptional efficiency pronouncements. (The telephone was invented quite a while ago, the latter is just common sense.)
- Prevention of Prescription Drug Abuse – Also on the Hill, Dr. Sandra Kweder testified before the Subcommittee on Criminal Justice, Drug Policy and Human Resources Committee on Government Reform. Dr. Kweder reviewed FDA actions aimed at preventing abuse and misuse and the work the agency has undertaken with the Drug Enforcement Agency and others.
- Gottlieb Speech Before Center for Science in the Public Interest Conference on Government Advisory Committees – Dr. Scott Gottlieb, Deputy Commissioner for Medical and Scientific Affairs at FDA spoke at the Conference on Government Advisory Committees of the CSPI. He discusses the role of advisory committees in the FDA process and puts some context at a time when there is a great deal of scrutiny on the process. He directly addresses the negative impact some legislative reform proposals could have. I, for one, think he is right.
- Medicare Part D Check UP – If we need more testament to the fact that it is going to take a while for the smoke to clear on Medicare Part D, triumph or failure, here it is. The Kaiser Family Foundation conducted a survey that showed that most seniors are pleased with the program. Though a large number of problems were reported, some of which were serious, 90% felt that the problems were resolved. Some partisans are furious about any speculation that the program has flaws, but I say the jury is still out. Be patient, perhaps the jury will reach a verdict in about November. No sense in speculating.
Have a good weekend everybody! Yee ha!
