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: OTC Switches
Good Time to Move on Plan B
Last week, former Acting Commissioner and former Commissioner Lester B. Crawford admitted in a deposition that he acted to pre-empt FDA staff from approving the OTC switch of Plan B, according to a report in the Baltimore Sun. What he … Continue reading
Posted in FDA Policy, OTC Switches
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Statins and The RX to OTC Switch Pipeline
As mentioned yesterday, the increase in the number of patent expirations set for the next few years indicates an opportunity for an increase in RX to OTC switches. In March, I had a posting on the challenges in the current … Continue reading
Posted in OTC Switches
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The RX to OTC Switch Environment
There are fewer drugs available for switching from prescription to over-the counter status than there have been in years gone by. Several years ago I was involved providing counsel on the largest switch of a drug from prescription (RX) to … Continue reading
Posted in OTC Switches
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