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: Warning Letters
OPDP Takes Second Enforcement Action of the Year
This week FDA’s Office of Prescription Drug Promotion (OPDP) posted what was only the second enforcement letter of the year which was issued in May. Warning letters are issued by many parts of the FDA, but OPDP issues letters squarely … Continue reading
Posted in FDA Policy, Warning Letters
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Enforcement Updates: OPDP Issues First Letter of the Year
In recent years, FDA’s Office of Prescription Drug Promotion (OPDP) has been diminished in the volume of its enforcement expressed through the issuance of Warning and Untitled Letters. OPDP now sends out only a handful of letters each year when … Continue reading
Speaking of Communications – OPDP on the Move
Over the past few years, regulatory action letters from FDA’s Office of Prescription Drug Promotion (OPDP), while once plentiful, has been something of a rare occurrence. In response to questions on the matter, FDA was often vague. This week however, … Continue reading
Posted in FDA Policy, Warning Letters
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OPDP Enforcement Letters at Record Low
The Office of Prescription Drug Promotion (OPDP), once known as the Division for Drug Marketing, Advertisting and Communications (DDMAC) monitors company communications about medical products and when it deems those communications have gone outside regulatory parameters, the office issues a … Continue reading
Posted in Warning Letters
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OPDP Sends First Letter of 2017
To put it mildly, enforcement by the Office of Prescription Drug Promotion (OPDP) has been lagging. Warning and Untitled letters from this office numbered in the triple digits twenty years ago. In the past three years, it did not break … Continue reading
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