Category Archives: Op-Ed

CMS Struggles to Fix Sunshine System

The feds have “a long way to go” to get the Open Payments system operating effectively and user friendly, according to officials in charge of the financial disclosure program. “Sunshine” went live September 30, 2014, as scheduled, but incomplete and contradictory data listings made it necessary to withhold nearly one-third of financial transaction reports from […]
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New Republican Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy

The 2014 mid-term elections handed over control of the Senate to Republicans and boosted the GOP majority in the House, a clear blow to Obama administration policies, including the president’s landmark health reform initiative.  Voters were most dismayed about the economy and lack of jobs, but U.S. military snafus overseas and concerns about the Ebola […]
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We Need to Rock the Boat to Make Research Soar

By Wayne Kubick, Applied Clinical Trials. We hear it all the time these days: research processes have to undergo transformative changes in order for research organizations to thrive—or even survive. Controlled clinical trials take too long and cost too much. Regulatory review is blocking innovation. Research data must be shared transparently, drug manufacturers need to […]
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So Who’s in Charge of Medicines in Brussels?

So now we know who is to do what on health issues in the new European Commission. Or do we? The furor that the new boss of the commission, Jean-Claude Juncker, unleashed with the plans for his new team, weeks before it took office, is still reverberating around Brussels. Peter O’ Donnell reports on the […]
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"Sunshine" Policy Continues To Exempt CME Funding

A federal policy issued late last week appeared to deal a serious blow to continuing medical education (CME) programs supported by biopharma companies. But the specifics published by the Centers for Medicare and Medicaid Services (CMS) Oct. 31, 2014 actually continue to exempt independent CME funding from the Open Payments reporting requirements for transfers of […]
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