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US Sunshine Act

Comparing Transparency Reporting Requirements in Canada, the United States and Europe

The Strengthening Quality and Accountability for Patients Act 2017 (the “Transparency Act”) was passed in December 2017 and requires the reporting of transfers of value (“TOV”) from manufacturers (e.g., pharmaceutical, medical device, generics, medicinal marijuana, etc.), pharmacies, laboratories, organizers of continuing education events and “a prescribed person or entity” to prescribed recipients in Ontario. Like the U.S. Sunshine Act and the EFPIA reporting requirements, the Transparency Act was created with the goal of strengthening transparency by requiring companies to track and report certain payments and items of value. However, the reporting requirements under the Act are still somewhat unclear and …

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Oregon: Transparency’s Latest Frontier

Transparence santé, Sunshine Act

On March 13, 2018, Oregon Governor Kate Brown signed a bill that requires drugmakers to report research and development and marketing costs, along with profits and more, for drugs that get price hikes of more than 10%. Companies will also be required to report whether generics are available. The Oregon bill (HB 4005) is the most recent state-level drug pricing transparency law that attempts to control the cost of prescription drugs and is quite similar to the California legislation that is the subject of a legal challenge. However, HB 4005 goes a step further than that California legislation and seems …

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Undisclosed conflicts of interest among biomedical textbook authors

Textbooks are a formative resource for health care providers during their education and are also an enduring reference for pathophysiology and treatment. Unlike the primary literature and clinical guidelines, biomedical textbook authors do not typically disclose potential financial conflicts of interest (pCoIs). The objective of this study was to evaluate whether the authors of textbooks used in the training of physicians, pharmacists, and dentists had appreciable undisclosed pCoIs in the form of patents or compensation received from pharmaceutical or biotechnology companies Authors were listed as inventors on 677 patents (maximum/author = 23), with three-quarters (74.9%) to HarPIM authors. Females were …

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The biopharmaceutical’s stock took a tumble after the Wall Street Journal asserted that the company has been breaking the Sunshine Act

Code of Disclosure, Sunshine Act, Transparency

Shares of MiMedx Group (NASDAQ:MDXG), a biopharmaceutical company focused on regenerative medicine, were down 11% as of 3:15 p.m. EST on Friday. The drop was spurred by an article published on Thursday stating that the company had failed to make legally required reports of payments that it made to doctors. The article published by The Wall Street Journal stated that MiMedx had not disclosed its financial relationships with more than 20 doctors — a failure to comply with the Physician Payments Sunshine Act, which was passed in 2013. To read the article by Brian Feroldi

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New Jersey Finalizes “Gift” Ban of Physicians Working with the Pharmaceutical Industry

Transparence santé, Sunshine Act

In an unusual administrative move – without passing any new laws – on December 22, 2017, the Attorney General of New Jersey finalized new rules governing physician interactions with pharmaceutical companies. The rule is titled:   LIMITATIONS ON AND OBLIGATIONS ASSOCIATED WITH PRESCRIBER ACCEPTANCE OF COMPENSATION FROM PHARMACEUTICAL MANUFACTURERS. Starting January 15, 2018, all contracts and payments entered into by physicians directly with the pharmaceutical industry will be subject to a $10,000 total yearly cap for New Jersey physicians with all pharmaceutical companies. This includes payments from industry for consulting and speaking but exempts research and education related payments. In addition, …

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Blumenthal & Grassley Ask HHS to Prioritize Funding for Program to Enhance Transparency in Opioid Prescribing

[WASHINGTON, DC] – In a letter to Acting Secretary of the U.S. Department of Health and Human Services (HHS) Eric D. Hargan, U.S. Senators Richard Blumenthal (D-CT) and Chuck Grassley (R-IA), asked HHS to prioritize funding for the Center for Medicare and Medicaid Services’ Center for Program Integrity (CPI), a program that enhances transparency in transactions between medical providers and pharmaceutical companies. The CPI’s Open Payments database, created under the bipartisan Physician Payments Sunshine Act, mandates disclosure of billions of dollars in payments from manufacturers to prescribers and hospitals. This is of particular concern at a time when over-prescribing of …

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