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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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Thomas P. Stossel, MD, MD (Hon), is a visiting scholar at the American Enterprise Institute and professor emeritus at Harvard Medical School, who has recently published several articles on how to remove barriers to medical innovation, and how medical innovation... Continue reading
Posted yesterday at Policy and Medicine
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While False Claims Act cases are relatively common in the life science industry, FCA cases for cGMP violations are not. This article explores the most recent case involving Baxter Healthcare Corporation and some of its troubling implications. It was the... Continue reading
Posted yesterday at Policy and Medicine
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As has been reported, the FDA is under pressure to speed up approval of generic medicines. In response, the FDA released data indicating its actions on the approval of generic medication. However, as noted by NPR in one example consumers... Continue reading
Posted 2 days ago at Policy and Medicine
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The Food and Drug Administration (FDA) has announced a public workshop to obtain input on issues and challenges associated with federal efforts to train prescribers on pain management and the safe use of opioids. The workshop has three major goals.... Continue reading
Posted 2 days ago at Policy and Medicine
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Dr. Lynn Webster of Utah recently produced a documentary about pain treatment. The documentary, “The Painful Truth,” can be found online and on public television stations across the country and provides insight into the difficulties patients run into when trying... Continue reading
Posted 3 days ago at Policy and Medicine
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On January 11, 2017, the Office of Inspector General (OIG) at the U.S. Department of Health and Human Services (HHS), issued a new robust set of policy and rule-making guidelines, significantly clarifying and reaffirming regulatory efforts to place both individuals... Continue reading
Posted 3 days ago at Policy and Medicine
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Late last year, John Jenkins, director of the FDA’s Office of New Drugs told attendees at an event that the decline in new drug approvals (NDAs) was not due to a shift in FDA standards or policies. The number in... Continue reading
Posted 4 days ago at Policy and Medicine
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The Maryland House recently passed a bill – House Bill 631 – with the goal of “prohibiting a manufacturer or wholesale distributor from engaging in price gouging in the sale of an essential off-patent or generic drug.” Under the legislation,... Continue reading
Posted 5 days ago at Policy and Medicine
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The PRC continues to focus on three principle life science industry concerns: (1) drug quality, development, and approval; (2) healthcare affordability; and (3) preventing bribery and corruption in the healthcare industry. They recently published “Several Opinions Concerning Further Reforms of... Continue reading
Posted 5 days ago at Policy and Medicine
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In early March 2017, Senator Chuck Grassley sent a letter to the manufacturer of Auvi-Q (an epinephrine injector similar to EpiPen), requesting an explanation of its pricing, including which entities within the health care system pay the cited list price... Continue reading
Posted Apr 14, 2017 at Policy and Medicine
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The 340B Drug Discount Program plays an important role in the United States healthcare system by providing healthcare services primarily to entities that serve low-income populations. The program also is complex and evolving, so compliance challenges will abound for years... Continue reading
Posted Apr 14, 2017 at Policy and Medicine
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Senator Claire McCaskill, Ranking Member of the Senate’s Homeland Security and Governmental Affairs Committee, has launched a wide-ranging investigation into the business practices of the manufacturers of America’s top five prescription opioid products (based on 2015 sales). The investigation is... Continue reading
Posted Apr 13, 2017 at Policy and Medicine
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President Donald Trump recently met with several Democratic lawmakers regarding rising drug prices, including Representative Elijah Cummings and Peter Welch. Representative Cummings, Ranking Member of the House Committee on Oversight and Government Reform, has been an outspoken critic of the... Continue reading
Posted Apr 13, 2017 at Policy and Medicine
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Moments before a scheduled vote on the bill, Republican House leaders announced that they were pulling the American Health Care Act (AHCA) from consideration. Such a move, made because of a shortage of votes needed to pass the bill, has... Continue reading
Posted Apr 12, 2017 at Policy and Medicine
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On April 5, 2017, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a confirmation hearing on the nomination of Scott Gottlieb, M.D. to serve as Commissioner of the Food and Drug Administration (FDA). Members of the committee engaged... Continue reading
Posted Apr 11, 2017 at Policy and Medicine
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With the close of Open Payments submission just behind us, the Centers for Medicare & Medicaid Services (CMS) plans to publish the Open Payments Program Year 2016 data and updates to the 2013, 2014, and 2015 program years on June... Continue reading
Posted Apr 11, 2017 at Policy and Medicine
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In an article published in Science Translation Medicine, Disciplined approach to drug discovery and early development, Robert Plenge of Merck Research Laboratories writes on the best practices for drug discovery. He outlines what is necessary for the highest chances of... Continue reading
Posted Apr 10, 2017 at Policy and Medicine
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In early December 2016, the Sapin II law was enacted in France. The law, which is meant to promote transparency, fight against bribery, and modernize the economy, was pushed for two years by Transparency International. Corruption has long been criminally... Continue reading
Posted Apr 7, 2017 at Policy and Medicine
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In a March 3, 2017, letter to the United States Government Accountability Office, Senators Orrin Hatch, Chuck Grassley, and Tom Cotton raised the idea that regulatory or legislative changes might be needed to “preserve the intent of this vital law”... Continue reading
Posted Apr 6, 2017 at Policy and Medicine
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After a fairly slow 2016, the United States Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) issued a quick burst of letters in the span of nine days in December. This flurry of activity more than doubled... Continue reading
Posted Apr 5, 2017 at Policy and Medicine
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JAMA Internal Medicine recently published an article, “Patient Advocacy Organizations, Industry Funding, and Conflicts of Interest.” The article focused on the nature of industry funding of patient advocacy organizations (PAOs) in the United States. As the basis for the article,... Continue reading
Posted Apr 4, 2017 at Policy and Medicine
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The United States Department of Justice has announced the fiscal year 2016 recoveries from civil False Claims Act. This article delves into the numbers, extracting those recoveries related to the healthcare industry, and comparing DOJ-brought suits versus whistleblower-brought suits. The... Continue reading
Posted Apr 4, 2017 at Policy and Medicine
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Graham McMahon, MD, MMSc, President and CEO of the Accreditation Council for Continuing Medical Education (ACCME), recently published an article in Academic Medicine, “The Leadership Case for Investing in Continuing Professional Development.” In his article, Dr. McMahon calls upon healthcare... Continue reading
Posted Apr 3, 2017 at Policy and Medicine
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On May 16th and 17th, 2017, ExL Events will host the Fourth Promotional Review Committee Compliance and Best Practices Conference at The James Chicago in Chicago, IL. The Conference is the only industry forum devoted entirely to boosting the skills... Continue reading
Posted Apr 3, 2017 at Policy and Medicine
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In January, FDA’s Center for Drug Evaluation and Research (CDER) released its annual guidance agenda, announcing the new and revised draft guidances that the Center plans to publish during the 2017 calendar year. CDER’s 102-part agenda is organized by category... Continue reading
Posted Mar 31, 2017 at Policy and Medicine