- Court Rules Terminal Patients Have Right to Access Drugs – A federal court ruled that terminal patients may have a right to access drugs that have cleared Phase I studies but not approved. The case was before an appeals court and was sent back to a lower court where it may have a full hearing according to the Washington Post. The case was brought by the Abigail Alliance for Better Access to Developmental Drugs of Arlington, Virginia.
- Dr. von Eschenbach Speaks! – This actually happened a month ago at FDLI, but the agency only posted it this week. While not a headline grabber, at least it is a speech and he provides a few comments on the Critical Path Initiative. If interested, click here. He noted that it was exciting to lead the agency at this time in its history and "if" confirmed, it will be an honor to be Commissioner. I think that was wise use of terms.
- Dr. Lester Crawford Reportedly Under Investigation – Speaking of FDA Commissioners and confirmation – news that calls to mind the long-standing lack of leadership at the agency – Dr. Lester Crawford who held a tenure as Commissioner that lasted weeks is reportedly under grand jury investigation, a development to which the FDA offered "no comment".
- Resources Added to the Blog – To the left uhder the FDA Links section, you will now find a link to the FDA Web site that will take you directly to the data base that allows you to search the status of companies to their post-marketing commitments.
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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