- Bad Legislative Action – An amendment to a House appropriations bill that would have provided for greater FDA authority over drug safety in post-marketing studies was stripped from the legislation. Expect hearings on this later.
In another legislative development, an amendment was successfully attached to an appropriations bill that would forbid the FDA from allowing scientists and researchers from serving on advisory committees if they have a conflict of interest. In other words, no more waivers. Another amendment would pave the way for the importation of drugs.
- Drug Approvals – Remicade Approved for Kids – the FDA announced approval of Remicade for the treatment of Crohn’s Disease in children on May 19. Two days earlier, the agency approved Teva Pharmaceutical’s Azilect for the treatment of Parkinson’s Disease. Those who have ever suffered from shingles will be happy to know that Merck’s new vaccine today got approval as well.
- Gottlieb Speech – Dr. von Eschenbach continues to be quiet, but Dr. Gottlieb is out there talking. This time at Northwestern University on the future of drug development. No sign of any posting of Dr. Woodcock’s testimony before Congress on the RU-486 issue.
- Sinking Poll Numbers – Further evidence of the erosion of public confidence in the FDA seen in the latest Wall Street Journal/Harris poll which reveals that growing numbers feel that the FDA is basing decisions on politics, not science.
- Gene Treatment for Erectile Dysfunction – Research has been conducted on a gene transfer treatment for ED that would replace the need for taking a chemical compound. Whatever will we do without those charming commercials?
No Posting on Monday – I’m taking Memorial Day off. Have a good weekend and a good holiday.