Weekly Roundup – 6/9/06
It was a busy week for everybody it appears:
- Woodcock Testimony on RU-486 – Dr. Janet Woodcock’s testimony before Congress on RU-486 is still not posted to the FDA site. An email to the Webmaster inquiring on timing for its posting went unanswered.
- Tysabri - The MS medication Tysabri returns to market under a new risk management program. The problem, you may recall, was that some patients developed the horrible infection PML. Risk management is comprised of mandatory patient registration, which doesn’t prevent infection, but will try to track it if it occurs.
- von Eschenback Speaks! – Dr. von Eschenbach actually gave a speech and I was there in person to hear it. No copy available yet, but he spoke for nearly an hour and said nothing of any substance. He did offer some very vague and lofty goals for the agency – nothing about the challenges they face. Ironically he did make a commitment to guide the FDA in the future as it has in the past – an agency based on science. He did not reconcile the handling of Plan B in that context.
- Cancer Vaccine Approved – The first cancer vaccine was approved by the agency this week. The product is called Gardasil and is manufactured by Merck. It is designed to prevent cervical cancer, precancerous genital lesions and genital warts due to human papillomavirus (HPV).
- Crackdown – FDA announces a crackdown on unapproved drugs and will issue a final guidance document.
- FDA Slumps in Poll – The Wall Street Journal/Harris Poll finding that public confidence in the agency is eroding. A wake-up call for the agency, but no signs that they are listening.
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