Eight years ago, the FDA was a gold standard agency. Today that gold is tarnished by eight years lacking in leadership, vision and growth with the times. High level mis-steps and a lack of momentum has caused a crisis in credibility among policy-makers and the public in the once highly regarded agency. That is a bad place for an agency that regulates over one-fourth of the U.S. economy. Dr. Margaret Hamburg, as the new commissioner, will have her hands full. Last year, the agency received the lowest public opinion rating it had ever gotten and this year, polls showed some improvement, but still with a long way to go.
About the Author
My 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.Stay Connected
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I 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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