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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Category Archives: DTC Advertising
Tick Tock re Tik Tok and FDA’s OPDP
Tik Tok was first released in 2016. While slow out of the starting gate with emergent media opportunities, in 2022, pharma is embracing the platform in both unbranded and branded efforts. While historically, a lot of Tik Tok use has … Continue reading
Posted in DTC Advertising, FDA Policy, Regulatory Communications Comments Off on Tick Tock re Tik Tok and FDA’s OPDP
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 Comments Off on FDA OPDP Look Back at 2021 – The Yawning Gap
HHS Proposes Pricing in DTC
In May the Administration released a plan called “America’s Patients First” , a blueprint to lower drug prices and reduce out-of-pocket costs. One of the items contained in that blueprint was to have the manufacturers of medicines include the list … Continue reading
Posted in DTC Advertising, FDA Policy Tagged DTC, FDA, Pharma, pricing Comments Off on HHS Proposes Pricing in DTC
DTC and OPDP
It is a different era of enforcement. So far the first quarter of 2017 has not yielded a single regulatory action letter from the Office of Prescription Drug Promotion (OPDP). That said, in December of 2016 OPDP put out more … Continue reading
Posted in DTC Advertising, Warning Letters Comments Off on DTC and OPDP
Health for Sale – What Would DDMAC Do?
Last week I was fortunate enough to catch a segment of the PBS News Hour that featured a new exhibit at the Philadelphia Art Museum called “Health for Sale“. The exhibit is comprised of the direct-to-consumer (DTC) of yesteryear – … Continue reading
Posted in DTC Advertising, Miscellaney, Uncategorized Comments Off on Health for Sale – What Would DDMAC Do?