- Warnings to Consumers on Erectile Dysfunction Remedies Sold On Internet – The FDA issued both a press release and a MedWatch alert warning consumers on products purchased on the Internet promising to address E.D. According to the alert the products "pose a threat to consumers because the undeclared ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates."
- One A Day-Three Drug Combo for HIV Approved – As reported here earlier this week, on July 12, the FDA approved the first 3-drug combination HIV medication that can be administered once a day, overcoming scientific, logistic and business obstacles in doing so. The drug was named Atripla. (Who get’s to give out those names?)
- Counterfietting Testimony Before House – Randall W. Lutter, Ph.D., Associate Commissioner for Policy and Planning offered testimony before the Subcommittee on Criminal Justice, Drug Policy, and Human Resources Committee on Government Reform House of Representatives on prescription drug counterfeit measures. Interstingly, this is the same subcommittee that Dr. Janet Woodcock testified before in May but which the FDA never posted to their Web site. It can however be found here.
- Rove Promises Veto on Stem Cell Bill – With various proposals floating around Congress regarding stem cell research, Karl Rove indicated that the President will veto a bill that would expand federal funding for stem cell research. He said that the President was emphatic about this, as opposed to empathetic.
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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