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: Risk Management
No Rest for the Weary
New warnings were issued by the FDA for prescription sleep aids yesterday. The media coverage of the issue focused on the claim by some users of these drugs that they experienced "sleep-driving" – getting dressed and getting in a car … Continue reading
Posted in Risk Management
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Ketek Gets New Label
The FDA announced the issuance of a new label for Ketek (telithromycin) that strips away two indications for use of the drug – acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis – and retaining the sole remaining indication, … Continue reading
Posted in Risk Management
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Testing Risk Management
Last night, ABC News carried a report that teen suicide has increased since the Black Box Warning was labeled for anti-depressants. It is very unpleasant news. The ABC News Report states that: "According to the Center for Disease Control and … Continue reading
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The New FDA Drug Safety Initiative – Policy and Communications Implications
Yesterday the FDA announced yet another new initiative on drug safety. This is apparently in addition to the pre-existing Drug Safety Initiative. It is an action taken in response to the Institute of Medicine (IOM) report – The Future of … Continue reading
Posted in FDA Image, Risk Management, Safety and Clinical Trials
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Anti-depressants and Labels
Yesterday, the FDA held an advisory committee meeting on the labeling of anti-depressants in adults. I was not present, but heard coverage of the meetings on National Public Radio. There was wrenching testimony by those who have lost loved ones … Continue reading
Posted in FDA Policy, Risk Management
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