- 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.
About the AuthorMy name is Mark Senak. I’m a lawyer and I work at the international communications firm FleishmanHillard in New York. For the past several years, I have been consulting with pharmaceutical and biologic companies that are engaged in the process of bringing new drugs to market. I have also worked extensively with an array of medical societies and patient organizations providing strategic communications counsel and media training.
My ProfileI am an authority on regulatory aspects of communications and medical products, with particular emphasis on pre-approval communications; strategist to help pharma and biotech companies prepare best case for advisory committee approval; and counselor in issues and crisis management. I am a frequent speaker on various aspects of same - drug development, promotion, reimbursement and new media in a highly regulated environment. Author of books, newspaper and magazine pieces related to drug marketing and promotion as well as HIV specialty pieces. And of course... blogger!
About This Blog
Eye on FDA is published by Mark Senak of FleishmanHillard’s New York office. The thoughts and ideas in this blog and postings are strictly my own and are not screened by my employer. Everything posted on this blog is my personal opinion and does not necessarily represent the views of FleishmanHillard or its clients.
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