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Thomas Sullivan - Policy & Medicine Writing Staff
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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Recently, the Senate Judiciary Subcommittee on Antitrust, Competition Policy and Consumer Rights held a hearing to examine Senate Bill 3056, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016. The bill was introduced by Senator Patrick... Continue reading
Posted 11 hours ago at Policy and Medicine
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The Office of Inspector General ("OIG") of the U.S. Department of Health and Human Services ("HHS"), has recently updated its guidance about its decisions to impose permissive exclusion and other integrity obligations to protect Federal health care programs ("FHP"). This... Continue reading
Posted 11 hours ago at Policy and Medicine
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Four United States senators sent a letter to United States Food and Drug Administration (FDA) Commissioner Robert Califf with concerns over the agency's apparent inability to revise, finalize, or withdraw draft guidance documents in a timely manner. The letter notes... Continue reading
Posted yesterday at Policy and Medicine
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Seventeen states have enacted legislation in an attempt to expand access to health care through expedited medical licensure. The Interstate Medical Licensure Compact offers an expedited licensing process for physicians that are interested in practicing medicine in multiple states. The... Continue reading
Posted 4 days ago at Policy and Medicine
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The United States Food and Drug Administration (FDA) has announced that it will start to gather information on creating a new user fee program for nonprescription, over-the-counter (OTC) drugs. The user fee program would provide funding to supplement congressional non-user-fee... Continue reading
Posted 5 days ago at Policy and Medicine
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Kurt Stitcher, Senior Compliance Consultant The U.S. Department of Justice's FCPA Pilot Program is nominally designed to encourage voluntary self-disclosure of FCPA violations by providing more certainty around the outcome of such disclosure. The price of this "certainty" is fairly... Continue reading
Posted 5 days ago at Policy and Medicine
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Merlin the Magician would be proud of a recent study published in JAMA Internal Medicine attempting to prove that doctors who receive small gifts of food are more likely to prescribe a branded drug than generic drugs. The authors linked... Continue reading
Posted 6 days ago at Policy and Medicine
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CMS recently released a proposed rule updating the Conditions of Participation (CoP) for 6,228 hospitals and critical access hospitals (CAH) that participate in the Medicare and Medicaid programs. By incorporating elements of the Department of Health and Human Services' (HHS)... Continue reading
Posted 7 days ago at Policy and Medicine
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The FDA and the GAO both released data on the FDA's performance in medical device regulation over the last several years. This article takes a close look at this data and compares it with the data available through the FDA's... Continue reading
Posted 7 days ago at Policy and Medicine
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In a blow to the Department of Justice and the Yates Memo, a Massachusetts jury acquitted Warner Chilcott executive Carl Reichel. Reichel was facing charges that he violated the Anti-Kickback statute by communicating to sales representatives that they could (and... Continue reading
Posted Jun 20, 2016 at Policy and Medicine
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A May 2016 report from the United States Government Accountability Office (GAO) is harshly critical of Private Medicare Advantage plans, stating that the plans have overbilled the government by billions of dollars, but have rarely been forced to repay the... Continue reading
Posted Jun 20, 2016 at Policy and Medicine
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In 2015, PhRMA member companies invested $58.8 billion in research and development, up 10.3% from 2014. The new R&D data is based on findings from the 2016 PhRMA annual member survey released in the 2016 Biopharmaceutical Research Industry Profile and... Continue reading
Posted Jun 17, 2016 at Policy and Medicine
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Sun Pharmaceuticals, India's largest drug maker, recently disclosed that the United States Department of Justice (DOJ) has subpoenaed the company seeking information about pricing and marketing of the generic drugs it sells in the United States. The anti-trust division of... Continue reading
Posted Jun 16, 2016 at Policy and Medicine
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In late March 2016, Novartis Pharmaceuticals Corp. (NPC) and the U.S. Department of Justice and the State of New York (collectively, "Government") corresponded with the presiding U.S. District Judge about an alleged "nationwide kickback scheme, spanning 10 years, to induce... Continue reading
Posted Jun 16, 2016 at Policy and Medicine
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It was recently announced that Jonathan Roper, a former District Manager at Insys Therapeutics, and Fernando Serrano, a former sales representative at Insys Therapeutics, were arrested and charged with violating the Anti-Kickback Statute. The allegations are made as a result... Continue reading
Posted Jun 15, 2016 at Policy and Medicine
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The United States Food and Drug Administration (FDA) has recently issued guidance in response to a request in the 21st Century Cures Act, in an attempt to ease the procedural challenges doctors and patients must navigate when seeking access to... Continue reading
Posted Jun 15, 2016 at Policy and Medicine
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On Thursday, June 9, 2016, United States District Court Judge Denise L. Cote approved a settlement stipulation to resolve the Government's claims against Salix Pharmaceuticals, a specialty pharmaceutical company based in Raleigh, North Carolina, that sells products used to treat... Continue reading
Posted Jun 14, 2016 at Policy and Medicine
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The price of prescription drugs has created much controversy in recent years. This article examines why the pharmaceutical industry is under such scrutiny despite the fact that expenditures for drug costs have remained steady, explores State and federal legislative response... Continue reading
Posted Jun 14, 2016 at Policy and Medicine
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In October 2012, the Centers for Medicare and Medicaid Services launched the Comprehensive Primary Care Initiative, in collaboration with thirty-nine private and public payers. Primary care practices that participated in the Initiative were required to make changes in care delivery... Continue reading
Posted Jun 13, 2016 at Policy and Medicine
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It's no secret that state legislatures are under intense pressure to take action to battle the opioid addiction problems within their state. In Utah, thirty to forty people die each month from heroin or opioid overdoses. That's more than the... Continue reading
Posted Jun 10, 2016 at Policy and Medicine
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On Friday, June 3, 2016, Vermont Governor Peter Shumlin signed into law a bill that aims to require greater transparency on behalf of drug manufacturers when they increase the prices of prescription medicine. The law, S.216, will require state health... Continue reading
Posted Jun 9, 2016 at Policy and Medicine
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The opioid epidemic has been a prominent talking point in many circles lately, including physician groups, Congress, and, of course, the pharmaceutical industry. There are many possible solutions coming out of these discussions, including ideas like: public health surveillance, provider... Continue reading
Posted Jun 9, 2016 at Policy and Medicine
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The Food and Drug Administration (FDA) has announced an information collection seeking sponsors of past and present biologic applications submit a proposed suffix composed of four lowercase letters for use as the distinguishing identifier included in the name designated by... Continue reading
Posted Jun 8, 2016 at Policy and Medicine
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Massachusetts is required to release annual Cost Trend reports that make recommendations and commitments to advance Massachusetts' health care reforms and work to improve healthcare in the Commonwealth. The recently-released 2015 report, issued by the Health Policy Commission (HPC), includes... Continue reading
Posted Jun 8, 2016 at Policy and Medicine
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The Department of Justice (DOJ) has announced that pharmaceutical companies Genentech and OSI Pharmaceuticals, LLC, will pay $67 million to resolve allegations that they made misleading statements about the effectiveness of the drug Tarceva to treat lung cancer. This settlement... Continue reading
Posted Jun 7, 2016 at Policy and Medicine