Category Archives: Op-Ed

Things Looking Up for Obamacare, But New HHS Chief Faces Tough 2015

This blog previously ran on Managed Healthcare Executive. The Obama administration received a substantial amount of good news last month. Not only did 8 million individuals enroll in qualified health plans, millions more joined Medicaid or obtained coverage through private markets. Additionally, health reform will cost $100 billion less than anticipated, according to the Congressional […]
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UK: Patient Group Sets Out Orphan Drug Charter

By Leela Barham. There has been a lot of concern about the decision to give the National Institute for Health and Care Excellence (NICE) the responsibility to look at “highly specialized technologies” (HSTs, or orphan drugs to you and me). That decision was taken just as the NHS across England was going through major reform […]
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The European Medicine Agency’s Transparency Dilemma

By Peter O’Donnell, Applied Clinical Trials. The European Medicines Agency thought it might at last be back on the road to salvation when Guido Rasi swept into town in 2011 and started ordering greater transparency in the agency’s operations. He was determined to seek a new type of trust with the agency’s various publics—and particularly […]
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The British Medical Journal's Statin 'Apology'

By Philip Ward. For any Brit involved in medical publishing, the British Medical Journal (BMJ) is the Holy Grail. So it came as a huge shock when editor-in-chief Fiona Godlee, MD, admitted last week that important — and seemingly quite basic — mistakes were made in a key paper on statins. Worse still, she didn’t […]
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FDA Takes First Amendment Issues "Seriously"

Several legal cases have challenged the Food and Drug Administration’s approach to regulating industry communications about medical products, and agency officials now are acknowledging the importance of addressing these developments head-on. In the wake of U.S. v. Caronia and IMS v. Sorrell, the spotlight is on speech-related activity, including product labeling and advertising and promotion […]
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