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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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Pharmaceutical and device manufacturers operating in France must brace for more extensive reporting requirements under the French Sunshine Act, or “Loi Bertrand.” Last week, the Conseil d’Etat, the French Government’s “advisor in matters concerning the preparation of draft legislation, ordinances... Continue reading
Posted 17 hours ago at Policy and Medicine
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Last week, in our Vermont transparency update, we wrote that Vermont’s Attorney General enforced the state’s Prescribed Product Gift Ban and Disclosure Law for the first time in nearly a year. Now, the AG's office just posted another enforcement document... Continue reading
Posted 17 hours ago at Policy and Medicine
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Pharmaceutical and device companies often bear the brunt of the kickback enforcement in the United States. The Anti-Kickback statute, however, is broadly drafted and establishes penalties for individuals and entities on both sides of the prohibited transaction—doctors included. The statute... Continue reading
Posted yesterday at Policy and Medicine
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According to America Speaks, a compilation of public opinion polls commissioned by Research!America, the majority of Americans agree with the central tenets of the 21st Century Cures Bill. "Majorities across the political spectrum say it is important that the new... Continue reading
Posted 4 days ago at Policy and Medicine
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Celltrion will have to wait longer than expected for FDA's Advisory Committee to review its application for Remsima, a biosimilar for Johnson and Johnsons’ Remicade (infliximab). Yesterday, FDA announced that they would be postponing the meeting of the Arthritis Advisory... Continue reading
Posted 5 days ago at Policy and Medicine
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An interesting claim against the pharmaceutical industry (though usually made by only industry's most hardened critics) is that companies don’t want to find a cure—they’d prefer lifelong patients. Recently, Gilead Sciences indeed found a cure for hepatitis C--one that both... Continue reading
Posted 5 days ago at Policy and Medicine
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In the last few months, Vermont’s Attorney General's Office has been busier than usual regarding its Prescribed Product Gift Ban and Disclosure Law. On February 2, 2015, the AG posted an enforcement action against LifeNet Health for failure to submit... Continue reading
Posted 6 days ago at Policy and Medicine
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Earlier this month, Minnesota-based ev3 agreed to pay $1.25 million to the Department of Justice to settle False Claims Act (FCA) allegations related to the company’s promotion of their atherectomy device, Silverhawk. The whistleblower complaint was initially filed in 2009,... Continue reading
Posted 7 days ago at Policy and Medicine
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The market research space is an interesting one as far as Sunshine reporting is concerned because it implicates many of the same challenging “indirect payment” issues we have seen related to continuing medical education (CME). This article describes a number... Continue reading
Posted Feb 23, 2015 at Policy and Medicine
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Recognizing that drug companies would actually incur a financial loss in developing important drugs for rare conditions, Congress passed the Orphan Drug Act in 1983. The Act offers incentives to induce companies to develop drugs and other medical products for... Continue reading
Posted Feb 20, 2015 at Policy and Medicine
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Apotex Inc. has announced that as of February 13, 2015, the FDA has accepted for filing the company's application for filgrastim, a biosimilar version of Amgen's Neupogen. The product was jointly developed with Intas Pharmaceuticals Ltd. Filgrastim is used to... Continue reading
Posted Feb 19, 2015 at Policy and Medicine
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AstraZenaca last week settled with the Department of Justice over allegedly offering kickbacks to Medco Health Solutions, a pharmacy benefits manager, in exchange for Medco maintaining AstraZeneca’s drug Nexium in favorable status on its formulary. AstraZeneca settled the allegations for... Continue reading
Posted Feb 18, 2015 at Policy and Medicine
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Last week’s CBI Medical Device and Diagnostic Compliance Congress featured an “enforcement panel” that discussed recent trends in healthcare fraud enforcement. Three U.S. Attorneys from the Department of Justice—Benjamin Wagner of the Eastern District of California, Jacob Elberg of New... Continue reading
Posted Feb 17, 2015 at Policy and Medicine
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The National Coalition on Healthcare recently held a discussion on the Physician Payments Sunshine Act. The discussion featured insight from Rodney Whitlock, who currently works for Senator Chuck Grassley (R-Iowa) as the Health Director of the Senate Finance Committee. Dr.... Continue reading
Posted Feb 13, 2015 at Policy and Medicine
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The Advanced Medical Technology Association (AdvaMed) on February 10th released a comprehensive set of policy proposals designed to renew the innovation ecosystem for medical technologies and diagnostics. View the proposal here. "[T]he innovation ecosystem that supports medical technology is severely... Continue reading
Posted Feb 12, 2015 at Policy and Medicine
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In March 2013, the Department of Health and Human Services Office of Inspector General released a report entitled Gaps in Oversight of Conflicts Of Interest in Medicare Prescription Drug Decisions. In that document, OIG was critical of the Center for... Continue reading
Posted Feb 12, 2015 at Policy and Medicine
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Minnesota-based medtech company, Medtronic Inc., has agreed to pay $2.8 million to resolve allegations that the company promoted its neurostimulator device for unapproved chronic pain treatment. According to the complaint, originally filed by former Medtronic sales rep Jason Nickell, Medtronic... Continue reading
Posted Feb 11, 2015 at Policy and Medicine
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Yesterday, CMS’ Open Payments team held an informal question and answer session. Doug Brown, director of the data sharing and partnership group within the Center for Program Integrity at CMS, spoke on a number of topics that compliance professionals have... Continue reading
Posted Feb 10, 2015 at Policy and Medicine
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FDA: Advertisements “should focus on the most important risk information rather than an exhaustive list of risks.” Over the past few years, the Food and Drug Administration (FDA) has conducted numerous studies showing that consumers don't actually read the long... Continue reading
Posted Feb 10, 2015 at Policy and Medicine
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The American Bar Association is offering a complimentary law student webinar, "Careers in Health Law: Practical Tips for Law Students to Identify Health Law Jobs," on Wednesday, February 18 at 1:00PM EST. This focused discussion is designed specifically to help... Continue reading
Posted Feb 9, 2015 at Policy and Medicine
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In a surprise move, the American Board of Internal Medicine (ABIM) suspended aspects of its maintenance-of-certification program and apologized after many internists and medical specialty societies raised concerns that it was a waste of time and money. ABIM President and... Continue reading
Posted Feb 9, 2015 at Policy and Medicine
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The Centers for Medicare and Medicaid Services (CMS) is hosting a question and answer session for their Open Payments system next Tuesday. As a reminder, 2014 data submissions are due by March 31, 2015. Mark your calendars and bring your... Continue reading
Posted Feb 6, 2015 at Policy and Medicine
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Dr. Margaret Hamburg will step down from her post as Commissioner of the FDA next month. Hamburg and the FDA were busy in the few days before the announcement of her resignation, however. The Agency released a budget request for... Continue reading
Posted Feb 6, 2015 at Policy and Medicine
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Dr. Margaret Hamburg, commissioner of the Food and Drug Administration (FDA), has resigned, and will leave the agency at the end of March. Stephen Ostroff, FDA’s chief scientist and a former official at the Centers for Disease Control and Prevention,... Continue reading
Posted Feb 5, 2015 at Policy and Medicine
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2015 is poised to be a big year for biosimilars. For starters, FDA owes industry more guidance on “interchangeability” and the agency’s views on naming of biosimilar products. On February 3, FDA released a call for comment asking stakeholders about... Continue reading
Posted Feb 5, 2015 at Policy and Medicine