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US Sunshine Act

PharmaCompliance le 23/06/2015 : Rencontrez le Responsable du Sunshine Act aux USA

Dr. Shantanu Agrawal, Administrateur délégué et Directeur au CMS Responsable du Sunshine Act aux USA inaugurera PharmaCompliance Paris 2015 et apportera un témoignage exceptionnel. A noter également sur le thème de la Transparence des liens d’intérêts : – Un point d’actualité sur la loi Bertrand et la transposition du Disclosure Code EFPIA en France par Sofia Afonso du LEEM – La présentation des résultats de l’enquête menée par le Think Tank Loi Bertrand et l’AFAR – Une table ronde avec le témoignage de trois laboratoires sur la mise en place du Disclosure Code EFPIA – Les interventions de trois experts …

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Open to Misinterpretation: Sunshine Act Disclosures Can Cloud Context of Reasons for Payments

Compliance

Jennifer Shimek | KPMG & Bret Bissey | MediTract A new wave of Open Payments (Sunshine) Act data will be available June 30, featuring updated 2013 and a first look at 2014 data about payments made to providers by drug and device makers. Data issued for the first time in September represented a benchmark when the Centers for Medicare and Medicaid Services required disclosures from drug and medical device makers about what they pay doctors and teaching hospitals. Disclosures provide transparency and can reveal potential conflicts of interest in healthcare. Current disclosures on the Open Payments Website (click here) lose …

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21st Century Cures draft bill: A step backwards from transparency

There is optimism that Congress will soon pass the 21st Century Cures bill. The draft bill proposed by the House Energy and Commerce Committee aims to foster medical innovation by streamlining the FDA regulatory process and increasing NIH research funding by $10 billion. The draft bill has overwhelming bipartisan support and will benefit patients, medical researchers, and pharmaceutical companies. However, it also includes a passage, which aims to amend the Sunshine Act and exempt pharmaceutical companies from reporting the payments they make to physicians for continued medical education (CME) programs. The supporters of this change argue that physicians learn about …

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Physicians Express Concern Over Sunshine Act Rollout

Doctors and pharmaceutical and device companies have worked hand-in-hand to advance medicine throughout history. Without such teamwork, essential innovations may have lived in obscurity or not have been developed at all. Yet, research and experience have also revealed that such financial ties can lead to bias in a doctor’s decision making, for instance influencing the drug he or she prescribes or the device used. In some cases, this influence may be detrimental to patients, scientific research or our health care system. The ubiquity of these physician–industry relationships, along with concerns about conflicts of interest, has spurred a national effort by …

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Pharmaphobia: The Conflict-of-Interest Myth

On April 29, the House Energy and Commerce Committee released a new discussion draft of the 21st Century Cures Initiative, a bill intended to revitalize and streamline American medical innovation. If we, as a nation, want to continue to lead the world in medical innovation, we cannot allow myths to unjustly color our impression of the biopharmaceutical and medical-device industries and those physicians and researchers who work with them. Several studies recently published in Health Affairs suggest that current profits may be insufficient to sustain our present level of medical innovation. We should avoid passing legislation that makes medical innovation less …

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A Dark Cloud Still Lingers Over Sunshine Act

By Evan Levine, M.D. George Orwell, the inventor of the Ministry of Truth, could not have coined a more biting and sarcastic title than the Sunshine Act. With the advance of the Affordable Care Act the Physician Payments Sunshine Act (now known as Open Payments) could certainly create a dark cloud over every physician who accepted any funding, even a cup of coffee, from Big Pharma or medical device companies; the sun would no longer shine over doctors who made thousands of dollars by giving talks for $2,000 a night in some expensive local restaurant, in front of physicians who …

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