- Unusual Warning Letter Posting – The FDA took the unusual step of posting a Warning Letter not on the Warning Letter Page, but on its home page relating to a manufacturer of flu vaccine. Vigilence over the flu vaccine manufacturing process has been a sore point for the FDA in the past – perhaps this is compensation for that.
- Dr. Woodcock’s RU-486 Testimony – For a time, I have been interested in the testimony of Dr. Janet Woodcock on RU-486. On May 17, 2006 Dr. Woodcock testified before the Subcommittee on Criminal Justice, Drug Policy and Human Resources Committee on Government Reform, U.S. House of Representatives regarding the adverse events and safety profile of RU-486. The hearing was given the somewhat stacked title "RU-486 – Demonstrating a Low Standard for Women’s Health?" The FDA has never posted her testimony in spite of the fact that all other agency testimony, I guess in the interests of transparency, appears to be posted to the FDA’s Web site almost immediately after given. I sent the FDA Web master an email asking when the testimony would be posted – the email went unanswered. It turns out the testimony is supplied elsewhere. It was on the HHS Web site. My apologies to those who already found it before me, I depended on the FDA site. However, it is noteworty that the subcommittee submitted questions to the FDA in late June followingDr. Woodcock’s testimony. These questions raise very serious questions regarding the FDA approach to RU-486 and judging by the attitude of the commitee, questions on reproductive health that are quite substantial. Hopefully the answers will be posted at some point to the FDA site.
- Opinion piece on Care for the Mentally Ill in Pharmaceutical Executive – Similar to a posting I wrote back in May, this week I have an opinion piece in Pharmaceutical Executive noting how pharmaceutical companies should couple with mental health organizations to erect a national system of care for the mentally ill. To see, click here. (Note, this bullet point was added one hour after today’s original posting at 6:30 AM)
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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