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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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Senator Elizabeth Warren (D-Mass) plans to introduce legislation that she believes will “substantially increase federal funding for the National Institute of Health.” Her proposal would require drug companies who enter into major settlements to pay NIH and FDA one percent... Continue reading
Posted 7 hours ago at Policy and Medicine
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Polaris, the global leader in consulting and technology for life science healthcare law compliance, recently announced several major recent developments. Visit Polaris' accompanying press release, reprinted here: First, Polaris proudly announced that Steve Vincze has joined as the managing partner... Continue reading
Posted 8 hours ago at Policy and Medicine
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A new bill has been introduced that would exempt from Sunshine Act reporting educational materials and transfers relating to continuing medical education. Congressmen Michael C. Burgess, M.D. (R-TX), Chairman of the House Energy and Commerce Subcommittee on Commerce, Manufacturing and... Continue reading
Posted 3 days ago at Policy and Medicine
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The Supreme Court on Tuesday handed down an important decision regarding how patent claims are handled on appeal. The U.S. Court of Appeals for the Federal Circuit hears every patent appeal in the country. Until yesterday, the Federal Circuit gave... Continue reading
Posted 4 days ago at Policy and Medicine
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Last month, the Centers for Medicare and Medicaid Services (CMS) issued three FAQs and a page of website guidance to supplement their recent decision to remove the continuing medical education (CME) exemption from the Physician Payments Sunshine Act. Unfortunately this... Continue reading
Posted 5 days ago at Policy and Medicine
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Drug advertisements that the Food and Drug Administration (FDA) believes minimize a product’s risks have long been one of the Agency’s prime enforcement targets. In drug ads on TV, we are now accustomed to expecting a laundry list of risks... Continue reading
Posted 6 days ago at Policy and Medicine
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A recent article by Harry Pellman, M.D. entitled The importance of bias in education dispels some of the myths about pharmaceutical company involvement in physician education. With 22 years of chairing the CME Committee of an active American Academy of... Continue reading
Posted 7 days ago at Policy and Medicine
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Each year the HHS Office of Inspector General (OIG) solicits recommendations for new or modified safe harbor provisions under the Anti-Kickback statute, as well as comments on developing Special Fraud Alerts. Comments to OIG’s Solicitation of New Safe Harbors and... Continue reading
Posted Jan 16, 2015 at Policy and Medicine
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Unlike the first Open Payments program year, which took place over a 5 month period from August 2013 – December 2013, the second year covers all of industries' 2014 payments or transfers of value to covered recipients. Data collection wrapped... Continue reading
Posted Jan 15, 2015 at Policy and Medicine
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The Food and Drug Administration seems poised for a busy 2015. The Agency’s Center for Drug Evaluation and Research (CDER) just released their annual guidance document agenda for 2015. They intend to publish 90 guidance documents this year, including several... Continue reading
Posted Jan 14, 2015 at Policy and Medicine
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Japanese pharmaceutical company, Daiichi Sankyo Inc., with U.S. headquarters in New Jersey, has agreed to pay $39 million to resolve allegations that it violated the False Claims Act. The complaint alleges that Daiichi marketed a number of its hypertension and... Continue reading
Posted Jan 13, 2015 at Policy and Medicine
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The Accreditation Council for Continuing Medical Education (ACCME) Board of Directors today announced that it has chosen Graham T. McMahon, MD, MMSc, as the new President and CEO. The Board chose Dr. McMahon unanimously, and he will begin his tenure... Continue reading
Posted Jan 12, 2015 at Policy and Medicine
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Manufacturers must report quarterly on their transfers of value made to advance practice registered nurses (APRNs) practicing in Connecticut. This group includes nurse practitioners, clinical nurse specialists, nurse anesthetists, and nurse midwives. APRNs are excluded from the reporting obligations under... Continue reading
Posted Jan 12, 2015 at Policy and Medicine
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CBI's 2015 Pharmaceutical Compliance Congress (PCC) will take place on January 27-28, 2015 at the Ritz Carlton in Washington, D.C. The Conference is in its 12th year, and continues to provide an impressive list of speakers covering a wide spectrum... Continue reading
Posted Jan 9, 2015 at Policy and Medicine
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Rep. Erik Paulsen (R-Minn) this week introduced a bill to repeal the 2.3 percent tax on medical device sales. The legislation is a bipartisan effort co-sponsored by Democrat Congressman Ron Kind of Wisconsin. This is the third time Paulsen has... Continue reading
Posted Jan 9, 2015 at Policy and Medicine
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The Centers for Medicare and Medicaid Services (CMS) will be hosting a call next Thursday, January 15, 2015 for an Open Payments Question & Answer Session. The session will begin at 11:30 AM EST. CMS notes that stakeholders should bring... Continue reading
Posted Jan 9, 2015 at Policy and Medicine
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January 1, 2015 was the initial deadline for manufacturers, wholesale drug distributors, and repackagers to provide product information to their trading partners along the supply chain in compliance with the Drug Supply Chain Security Act (DSCSA). On December 31, 2014,... Continue reading
Posted Jan 7, 2015 at Policy and Medicine
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FDA’s “Purple Book,” which lists all licensed biological products, currently has an empty column under the “biosimilar” heading, which would state imitation products deemed “highly similar” next to the listed reference. That may change soon. Tomorrow, the FDA will consider... Continue reading
Posted Jan 6, 2015 at Policy and Medicine
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The Food and Drug Administration (FDA) approved 41 new medicines in 2014, the most since 1996, when the agency approved a record 53. FDA approved 27 in 2013. The jump can be attributed to many new drugs for orphan diseases,... Continue reading
Posted Jan 5, 2015 at Policy and Medicine
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After more than a year of bipartisan work between Congressman Fred Upton (R-MI) and Congresswoman Diana DeGette (D-CO) on the 21st Century Cures initiative, promising legislation may be introduced before Congress in 2015. Over the past year, we have provided... Continue reading
Posted Jan 4, 2015 at Policy and Medicine
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2014 has been a big year for healthcare and continuing medical education (CME). Here are ten topics worth going back to that Policy and Medicine has covered over the past 12 months. 1) The year of disclosures The Centers for... Continue reading
Posted Dec 30, 2014 at Policy and Medicine
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On December 22, the United States filed a civil False Claims Act complaint against Omnicare Inc. alleging that it solicited and received kickbacks from Abbott Laboratories in exchange for purchasing and recommending Depakote, a dementia drug for elderly patients. Omnicare... Continue reading
Posted Dec 29, 2014 at Policy and Medicine
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In an effort by FDA to project its future areas of focus, the agency has put forth a strategic priorities document for 2014 through 2018. The document outlines FDA’s five strategic priorities—regulatory science, globalization, safety and quality, smart regulation, and... Continue reading
Posted Dec 23, 2014 at Policy and Medicine
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On Friday, the Centers for Medicare and Medicaid Services (CMS) added approximately 68,000 payment records—valued at more than $200 million—to the Open Payments dataset. “With this new data, Open Payments now reports information on $3.7 billion in payments and transfers... Continue reading
Posted Dec 22, 2014 at Policy and Medicine
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GlaxoSmithKline’s 2012 Corporate Integrity Agreement made mandatory the company’s policy that it would not provide sales reps with incentive compensation based upon volume of sales. In December 2013, GSK announced that they would stop paying healthcare professionals to speak at... Continue reading
Posted Dec 19, 2014 at Policy and Medicine