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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Tag Archives: #OPDP
Speaking of Medicine – Mid-Year OPDP Enforcement Review
There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement … Continue reading
Posted in Uncategorized
Tagged #OPDP, #pharma
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Enforcement Update: OPDP Issues Untitled Letter
We are four months into the year, and this week OPDP has issued its fourth regulatory action letter of 2022. Two of the previous were Warning Letters, considered the more serious of the two categories, and two, including the latest, … Continue reading
Posted in Warning Letters
Tagged #OPDP
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OPDP Issues First Regulatory Action Letter of 2022
FDA’s Office of Prescription Drug Promotion (OPDP) issued the first regulatory action letter for 2022. This one has some notable characteristics. As has been frequently noted, enforcement actions by OPDP have diminished considerably over the years. Another characteristic of recent … Continue reading
Posted in Warning Letters
Tagged #FDA, #OPDP, #Untitled Letter, #Warning Letter
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FDA OPDP Look Back at 2021 – The Yawning Gap
Once again it was a quiet year with respect to the FDA’s Office of Prescription Drug Programs (OPDP). As noted in the past, there are two primary means for understanding the agency’s latest thinking with respect to promotional communications from … Continue reading
Posted in DTC Advertising, FDA, FDA Policy
Tagged #FDA, #OPDP, #pharma
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OPDP Sends Untitled Letter
Upfront Author’s Note: This is the first posting in a while as I have been working to migrate the subscription service to a new provider. As such, some subscribers were lost in the process. Anyone who signed up for a … Continue reading