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.
Category Archives: DTC Advertising
FDA Announces New Study on Endorsements and DTC Television Ads
In today’s Federal Register, the agency has announced that the Office of Prescription Drug Promotion (OPDP) is adding a new study effort to its research portfolio. The category of that body of research that is currently underway includes a range … Continue reading
Posted in DTC Advertising, FDA Policy
Tagged #DTC, #OPDP, #pharma
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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
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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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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
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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
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