- New Appointment at FDA for CDER – The FDA issued a press release announcing an appointment in a newly created position. The person is Dr. Paul Seligman. The position is – get this title – the Associate Center Director for Safety Policy and Communication in the Center for Drug Evaluation and Research (CDER). Hope they give him a big card. In the press release, Dr. Galson, Director of CDER, stated that "The appointment of Dr. Seligman represents our efforts to consolidate responsibility for developing Center-wide drug safety policy as well as coordinating our efforts in the area of risk communication. We anticipate that his step will help provide a more standardized and predictable approach to ensuring drug safety and enhance the effectiveness and timeliness of the information we provide to the healthcare community and the public." I hope that isn’t his job description. That said, the press release offered no insight as to what Dr. Seligman will actually do or how the industry can work with him on issues related to drug safety. Stay tuned.
- Bloody Bad Guys Nabbed – On a more interesting note, the FDA announced convictions in an illegal blood diversion scheme. According to the FDA press release, the bad guys were involved in illegal activities of various natures that bought and sold illegally obtained blood derivative products to the tune of defrauding Medicaid and Medicare programs of more than $45,000,000. Physicians received kickbacks for writing fake prescriptions that were then reimbursed and resold. It may not be the stuff that crime shows are made of, but represents good work on the part of the Office of Criminal Investigations by the FDA.
- Hot Topics Page Created – on the Bausch and Lomb contact lens situation. For the latest, click here.
- Annual Generic Drug Forum Speech – If you are interested in the weedy details of FDA approval of generics, Dr. Gottlieb gave a speech on it at the Annual Generic Drug Forum on April 7 that was just posted this week. Make sure you have coffee.
- FDA Sends Approvable Letter to GSK for OTC Xenical – Reportedly the letter does not demand new studies.
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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