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Thomas Sullivan
Columbia, Maryland
Former political consultant who founded Rockpointe, Inc. a bio-medical education company in 1995.
Interests: marketing, politics, baseball, cycling, medicine, university of florida sports, medical education, track and cross country, driving kids to various practices
Recent Activity
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During last week’s 2014 AMA Interim Meeting in Dallas, AMA House of Delegates voted to update the AMA’s policy on maintenance of certification (MOC). The adopted policy outlines principles that emphasize the need for an evidence-based process that is evaluated... Continue reading
Posted 2 days ago at Policy and Medicine
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The 4th Annual Health Law Regulatory & Compliance Competition will be held on Saturday, February 21, 2015, at the University of Maryland Francis King Carey School of Law. View the announcement and detailed competition information here. Download the Intent to... Continue reading
Posted 3 days ago at Policy and Medicine
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Yesterday, the Department of Health and Human Services and the National Institutes of Health (NIH) proposed to “increase the transparency of clinical trials via information submitted to ClinicalTrials.gov.” NIH notes that “[a] major proposed change from current requirements is the... Continue reading
Posted 3 days ago at Policy and Medicine
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Yesterday, the Office of Inspector General released their annual summary of the most significant management and performance challenges facing the Department of Health and Human Services (HHS). The 2014 Top Management and Performance Challenges lists ten issues reflecting continuing vulnerabilities... Continue reading
Posted 4 days ago at Policy and Medicine
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We often highlight the beneficial relationships between pharmaceutical and medical device companies and physicians, and the significant advances that are made possible by such collaboration. With the release of the Open Payments database—which details the payments from industry to physician—many... Continue reading
Posted 4 days ago at Policy and Medicine
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The Japanese pharmaceutical industry has been tracking and reporting transfers of value to healthcare professionals and academic centers based in Japan. In this article, we walk through the provisions of the Japanese transparency guideline before looking at the payment data... Continue reading
Posted 5 days ago at Policy and Medicine
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We frequently cover FDA regulations—proposed rules, FDA explanations, the role of collaboration between industry and FDA in the regulatory process, and recently the sometimes complicated relationship between industry and FDA. It probably then comes as no surprise that business leaders... Continue reading
Posted 6 days ago at Policy and Medicine
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At the end of October, the U.S. Food and Drug Administration (FDA) announced it is seeking feedback to improve communication with the agency during the clinical trials process. The announcement, posted on the Federal Register, notes the agency opened a... Continue reading
Posted 6 days ago at Policy and Medicine
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As the federal Sunshine Act has rolled out over the last year, Minnesota has been one of the few states that has added additional reporting requirements for drug (not device) manufacturers to track. By May 1, 2015, drug manufacturers must... Continue reading
Posted Nov 14, 2014 at Policy and Medicine
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The Amgen Foundation this week announced that its “Amgen Scholars Program” is expanding its presence with new host institutions in the U.S., Europe, and, for the first time, Japan. The Amgen Scholars Program "aims to inspire the next generation of... Continue reading
Posted Nov 14, 2014 at Policy and Medicine
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At least week’s Pharmaceutical Regulatory and Compliance Congress, conference attendees received some insight into the Open Payments program from its source. Doug Brown, the acting director of the data sharing and partnership group within the Center for Program Integrity at... Continue reading
Posted Nov 13, 2014 at Policy and Medicine
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Biotronik Inc. has agreed to pay $4.9 million to resolve kickback allegations brought under the False Claims Act, the U.S. Department of Justice announced last week. The settlement resolves allegations that the company induced doctors to continue using or convert... Continue reading
Posted Nov 12, 2014 at Policy and Medicine
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The Alliance for Continuing Education in the Health Professions is supporting an initiative to promote quality improvement programs through continuing education activities. ACEhp members are invited to submit comments on the “Quality Improvement Education” Roadmap for the committees’ consideration until... Continue reading
Posted Nov 11, 2014 at Policy and Medicine
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As physicians continue to adopt electronic health records as a part of the Meaningful Use program, we have provided updates from the Centers for Medicare & Medicaid (CMS) and the National Coordinator for Health IT (ONC). Recently, the continued struggle... Continue reading
Posted Nov 11, 2014 at Policy and Medicine
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On December 3, 2014, FDLI and the University of Maryland Schools of Law and Pharmacy will present Emerging Issues in FDA Law: Implementation of DQSA Click here to register. Use this code for a Policy and Medicine readers' discount: DQSA122014... Continue reading
Posted Nov 10, 2014 at Policy and Medicine
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Bio-Rad Labs recently agreed to pay a $14.35 million dollar penalty to resolve DOJ allegations that its subsidiaries made improper payments to Russian, Vietnamese, and Thai officials to win contracts in violation of the Foreign Corrupt Practices Act. DOJ alleged... Continue reading
Posted Nov 10, 2014 at Policy and Medicine
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On Wednesday, November 12, HHS Secretary Sylvia Burwell and Homeland Security Secretary Jeh Johnson will appear before the Senate Appropriations Committee to testify on the government’s response to Ebola. CDC Director Dr. Thomas Frieden, National Institute of Allergy and Infectious... Continue reading
Posted Nov 7, 2014 at Policy and Medicine
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EBI LLC, a subsidiary of Biomet, Inc. has agreed to a $6 million settlement with the U.S. Department of Justice to resolve kickback allegations connected to the company’s bone growth stimulators and “billing federal healthcare programs for refurbished stimulators.” The... Continue reading
Posted Nov 6, 2014 at Policy and Medicine
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CBI HCP Engagement, Data Validation and Reporting Conference offers senior-level executives the opportunity to adapt to the evolving landscape and transition as spend reporting becomes an intricate piece of HCP interaction. The conference will take place on November 18-19, 2014... Continue reading
Posted Nov 5, 2014 at Policy and Medicine
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Wednesday, 11/12/14: Off-label Marketing and Free Speech: Caronia and the Future of Speech in Therapeutic Product Promotion Information: The landmark decision in U.S. v. Caronia has emboldened drugs and biologics makers to contest charges of off-label marketing, including the currently... Continue reading
Posted Nov 5, 2014 at Policy and Medicine
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Yesterday, the Accreditation Council for Continuing Medical Education (ACCME) announced the publication of two reports addressing important issues in CME: the effectiveness of CME, and the relationship between commercial support and bias in CME activities. The author of the study,... Continue reading
Posted Nov 5, 2014 at Policy and Medicine
Today at 3:30 pm Eastern, view a complimentary online broadcast of Sunshine Implementation as part of the Fifteenth Pharmaceutical Compliance Congress and Best Practice Forum being held in Washington, DC. Click Here to view. THIS SESSION WILL BE INTERNET VIDEO... Continue reading
Posted Nov 4, 2014 at Policy and Medicine
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In April, we wrote that Asia's biggest pharmaceutical company, Takeda, and their marketing partner, Eli Lilly, faced $9 billion in punitive damages stemming from potential cancer risks from their diabetes drug, Actos. The companies recently moved for a new trial... Continue reading
Posted Nov 4, 2014 at Policy and Medicine
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On July 3, 2014, the Centers for Medicare and Medicaid Services (CMS) proposed rates for the 2015 physician fee schedule that would have cut radiation oncology payments by 4 percent and community-based radiation therapy centers by 6 to 8 percent.... Continue reading
Posted Nov 4, 2014 at Policy and Medicine
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On Halloween evening, October 31st, the Centers for Medicare and Medicaid Services (CMS) issued their final physician payment fee schedule for 2015, which included their changes to the Final Rule implementing the Physician Payments Sunshine Act. The agency’s brief announcement... Continue reading
Posted Nov 3, 2014 at Policy and Medicine