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: Proposed Legislation
House Appropriations Proposes Specific Cuts for the Continuing Resolution
Yesterday morning I posted about impending budget cuts to FDA for the next fiscal year and posed the question whether or not less money might equate to less enforcement. Ironically, a short time later, the House Appropriations Committee released a … Continue reading
Posted in Legislation, Proposed Legislation
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The Ever Growing FDA – Pending Regulations and Proposed Legislation
The Food and Drug Administration now regulates about one-fourth of the goods in the American economy. That's a lot of stuff. The agency oversees biologics and drugs product approvals, labeling for a slew of medical products, medical product manufacturing standards … Continue reading
Posted in Proposed Legislation
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White House Opens Up New Web Site on Health Care Reform
In addition to the existing site HealthReform.gov, the Obama Administration has set up a new part of WhiteHouse.Gov called "Reality Check" to address some of the myths surrounding the debate on health care reform. It is good use of a … Continue reading
Posted in Proposed Legislation
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The Other Health Care Reforms – FDA Growing by Leaps and Bounds
When the term "health care reform" is uttered, the mind unfailingly goes to think of the current bills being debated here in Washington to change the way health care is delivered in this country, most notably H.R.3200. But there are … Continue reading
Posted in Proposed Legislation
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Are Increased Foreign Inspections of Plants the Answer to Better Risk Management?
This week, Senators Kennedy and Grassley announced that they were reviving a legislative proposal from the last Congress that would increase the ability of the FDA to conduct foreign inspections of manufacturing facilities for drugs and devices where components are … Continue reading
Posted in Proposed Legislation
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