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 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
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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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
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MAD Doctors! FDA Deputizes Docs to do DDMAC Ad Reviews!
"Paging Dr. Draper! Paging Dr. Draper! We have an ad in the examination room that requires your attention, STAT!" The PA system goes quiet. In the waiting room, patients shuffle their feet nervously, waiting, waiting, waiting…. Dr. Draper enters the … Continue reading
Posted in DTC Advertising, FDA Policy, Warning Letters
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