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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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As physician practices consider joining an alternative payment model (APM), Medical Economics published an interesting list of items that should be considered before making the jump into an APM. This is increasingly important as MACRA incentivizes APMs and private payers... Continue reading
Posted yesterday at Policy and Medicine
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The concern of misbranded products leading to patient harm and potential fraud is inarguable. The FDA has held a long-standing position on off-label communication; however, in light of recent federal lawsuits that have increased the uncertainty of its enforceability, as... Continue reading
Posted yesterday at Policy and Medicine
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The FDA recently released draft guidance offering recommendations for holders of biologics license applications (BLAs) on the minor changes that should be documented in an annual report. As the number of chemistry, manufacturing and controls (CMC) postapproval manufacture supplements continue... Continue reading
Posted 2 days ago at Policy and Medicine
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A coalition of 41 states' attorneys general have served five major opioid manufacturers with subpoenas seeking information about how these companies marketed and sold prescription opioids. The coalition is also demanding documents and information related to distribution practices from three... Continue reading
Posted 3 days ago at Policy and Medicine
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On September 27, 2017, AmerisourceBergen Specialty Group (ABSG), a wholly-owned subsidiary of AmerisourceBergen Corporation, one of the nation’s largest wholesale drug companies, pled guilty to illegally distributing misbranded drugs. ABSG agreed to pay a total of $260 million to resolve... Continue reading
Posted 4 days ago at Policy and Medicine
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At the end of September, Florida Governor Rick Scott announced that during the upcoming legislative session, he will propose new legislation – including more than $50 million to next year’s budget – to combat opioid abuse in Florida. The proposed... Continue reading
Posted 5 days ago at Policy and Medicine
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The American Board of Medical Specialties (ABMS) and its twenty-four Member Boards have launched a major initiative, "Continuing Board Certification: Vision for the Future" (Commission). A collaborative process, the Commission will bring together multiple partners to vision a system of... Continue reading
Posted Oct 13, 2017 at Policy and Medicine
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The American Medical Association (AMA) and the ACCME are working together to develop a list of frequently asked questions (FAQ), instructions for designating credit, and other resources that will be available by the end of September. These resources will support... Continue reading
Posted Oct 12, 2017 at Policy and Medicine
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MedTech Europe represents the medical technology industries as a joint venture between EDMA and Eucomed and promotes a balanced policy environment that helps the medical technology industry meet Europe’s growing healthcare needs and expectations. In 2015, MedTech Europe implemented a... Continue reading
Posted Oct 11, 2017 at Policy and Medicine
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On June 23, 2017, the Belgian “Sunshine Act” became law, requiring life science companies to disclose relationships with healthcare actors in the country. The Decree confirmed that the first publication of data under the statutory transparency regime will cover transfers... Continue reading
Posted Oct 10, 2017 at Policy and Medicine
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We have written numerous times on the transparency bills in various states. California’s Senate Bill 17 is one of those bills that has worked its way through the statehouse and was signed today by Governor Jerry Brown’s desk. The law... Continue reading
Posted Oct 9, 2017 at Policy and Medicine
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The FDA announced a draft guidance for industry titled “Statistical Approaches to Evaluate Analytical Similarity”. The draft guidance offers advice to biosimilar sponsors on the evaluation of analytical similarity of a biosimilar to its reference product. FDA says this type... Continue reading
Posted Oct 6, 2017 at Policy and Medicine
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The Centers for Medicare & Medicaid Services (CMS) announced it will officially withdraw the controversial Obama-era Medicare Part B Drug Payment Model Demonstration, almost ten months after the Obama administration announced that they would not finalize the demo. Under President... Continue reading
Posted Oct 5, 2017 at Policy and Medicine
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As the FDA looks to boost generic competition, a new working paper published by the National Bureau of Economic Research (NBER) suggests that competition among generic drugmakers slows over time, potentially leading to higher prices for older treatments and drug... Continue reading
Posted Oct 4, 2017 at Policy and Medicine
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The California Assembly and Senate recently passed AB265, focused on amending price discounts permitted on prescription drugs. The legislation was initially offered by Assembly Members Wood and Chiu on January 31, 2017. The legislation passed the Assembly on May 31,... Continue reading
Posted Oct 3, 2017 at Policy and Medicine
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California’s Senate and Assembly have both passed legislation on publishing prescription drug prices (SB-17) and presented the legislation to California Governor Jerry Brown on September 19, 2017. Under California law, the Governor has twelve days to sign or veto the... Continue reading
Posted Oct 2, 2017 at Policy and Medicine
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On Tuesday, October 31, 2017, our editor Thomas Sullivan will be a host of “Risks and Opportunities in Today’s Changing World of Continuing Medical Education,” a webinar. The webinar will discuss ways to take advantage of the unique opportunities presented... Continue reading
Posted Oct 2, 2017 at Policy and Medicine
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On September 26, the Senate passed the CHRONIC Care Act is also known as the “Creating High-Quality Results and Outcomes Necessary to Improve Chronic Care Act.” The law passed with bipartisan support. “This legislation will improve disease management, lower Medicare... Continue reading
Posted Sep 29, 2017 at Policy and Medicine
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On October 25, 2017, Andrew Rosenberg at Thorn Run Partners and Thomas Sullivan, our editor and President of Rockpointe Corporation, will present a webinar on CME and federal policy. The webinar will be hosted by the Alliance for Continuing Education... Continue reading
Posted Sep 29, 2017 at Policy and Medicine
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United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently spoke with attendees of the Regulatory Affairs Professionals Society (RAPS) Regulatory Convergence conference about the steps the FDA is taking to make the clinical end of drug development more... Continue reading
Posted Sep 28, 2017 at Policy and Medicine
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Michael Munger, MD, recently assumed the role of president of the American Academy of Family Physicians (AAFP). During his opening speech, he spoke about the progress being made in moving toward a value-based care approach and the angst many members... Continue reading
Posted Sep 27, 2017 at Policy and Medicine
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On July 26, 2017, the Washington State Attorney General (“AG”) Bob Ferguson (“Ferguson”) announced one of the State’s largest recoveries against the Pharmaceutical Company Celgene (“Celgene”) for allegations involving violations of the Medicaid False Claims Act, in particulars claims related... Continue reading
Posted Sep 27, 2017 at Policy and Medicine
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Life science teams employ several different types of independent medical education providers. These providers include dedicated third parties, hospitals, professional medical societies and academic institutions. Several factors such as corporate goals, public perception, drug program type and cost influence the... Continue reading
Posted Sep 26, 2017 at Policy and Medicine
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We found an interesting Regulatory Focus story on the lack of FDA guidance documents since the start of President Trump’s tenure in office. FDA announced it intended to release more than 100 draft guidances in 2017 but has not been... Continue reading
Posted Sep 25, 2017 at Policy and Medicine
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In a nearly decade long lawsuit involving the dialysis company Fresenius, and allegations that the company violated the False Claims Act by conducting and then billing the government for medically unnecessary hepatitis B tests, Fresenius is now seeking to challenge... Continue reading
Posted Sep 25, 2017 at Policy and Medicine