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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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The Food and Drug Administration (FDA) is hosting a two-day long Joint Meeting of the Drug Safety and Risk Management Advisory Committee (DSaRM) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) to discuss results from assessments of the... Continue reading
Posted 10 hours ago at Policy and Medicine
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The Annual Forums on Transparency and Aggregate Spend are coming up. The 7th Annual West Coast Forum on Transparency & Aggregate Spend will be held May 18-19, 2016 at the Westin in San Diego, CA. The 10th Annual Forum on... Continue reading
Posted 10 hours ago at Policy and Medicine
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The Department of Justice ("DOJ") recently entered into a settlement of a quit tam lawsuit against Pfizer, Inc. and Wyeth, LLC. We previously wrote about this settlement back in February, when an "agreement in principle" was reached between Pfizer and... Continue reading
Posted yesterday at Policy and Medicine
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This article examines an apparent breakdown in corporate culture that goes beyond the subsidiaries to the parent company, Olympus Corporation. It is a cautionary tale for life science compliance officers on the importance of corporate culture's impact on successful (or... Continue reading
Posted yesterday at Policy and Medicine
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The IMS Institute for Healthcare Informatics released its annual Medicines Use and Spending in the U.S. report. Spending Report The report showed that spending on prescription drugs in the United States rose 12% over the last year, mostly fueled by... Continue reading
Posted 2 days ago at Policy and Medicine
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Corporate Integrity Agreements are thought to set the standard for compliance programs, but when viewed against the norms set out by a new report from the Ethics and Compliance Initiative's Blue Ribbon Panel, CIAs fall short. This article is the... Continue reading
Posted 2 days ago at Policy and Medicine
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The Centers for Medicare and Medicaid Services (CMS) released its proposed 962 page rule for the Medicare Access and CHIP Reauthorization Act (MACRA) of that links Medicare provider payments to quality patient care. The proposed regulation is the first major... Continue reading
Posted 5 days ago at Policy and Medicine
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Prescription drugs have been in the news for months: pricing issues, transparency problems, and the presidential campaign have all been keeping pharmaceutical companies in the limelight. Now, the United States Senate Committee on Homeland Security and Governmental Affairs has decided... Continue reading
Posted 6 days ago at Policy and Medicine
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ivities In this article, we review advice from industry thought leaders on (1) how to ensure compliance officers are a part of the process and not just brought in at the eleventh hour; (2) what to do if the compliance... Continue reading
Posted 6 days ago at Policy and Medicine
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In a recent securities filing, Novartis alluded to future issues for the Swiss company. In their Interim Financial Report, Novartis stated, "In Q1 2016, the Seoul Western District Prosecutor initiated a criminal investigation into allegations that Novartis Korea utilized medical... Continue reading
Posted 7 days ago at Policy and Medicine
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2016 has gotten off to a pretty good start for Polaris. In mid-April, the company finalized its third major deal of 2016: winning the largest contract in life science compliance technology history. The Polaris Global Compliance Platform was selected by... Continue reading
Posted 7 days ago at Policy and Medicine
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Readers who attended CBI's Annual Pharmaceutical Compliance Congress last year may have seen Securities and Exchange Commission (SEC) Enforcement Director Andrew Ceresney's speech about various focuses for the SEC. One of the focuses he mentioned was disclosures that concerned Food... Continue reading
Posted Apr 26, 2016 at Policy and Medicine
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The U.S. Supreme Court will shortly decide whether it will hear a case that will have a significant impact on the life sciences and medical device industry, specifically on the issue of whether approval by the Food and Drug Administration... Continue reading
Posted Apr 26, 2016 at Policy and Medicine
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The Office of the National Coordinator for Health IT (ONC) released a new request for information (RFI) in which they are seeking the public's thoughts on how to measure interoperability. The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)... Continue reading
Posted Apr 25, 2016 at Policy and Medicine
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"Don't stop trying" that is the theme of the Washington State legislature as overrode a governor's veto to push through a scaled down version of a pharmaceutical pricing bill . The state legislature of Washington State had an extended special... Continue reading
Posted Apr 23, 2016 at Policy and Medicine
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Late last year, we reported on the AMA's House of Delegates vote to adopt several recommendations in support of regulating medication pricing, including a recommendation that the AMA encourage the Federal Trade Commission to limit anticompetitive behavior by companies attempting... Continue reading
Posted Apr 22, 2016 at Policy and Medicine
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Dramatic increases in death due to prescription opioid abuse has gained national attention. In the last month alone, the Centers for Disease Control and Prevention (CDC) has issued new guidelines on prescribing opioids, the Food and Drug Administration (FDA) has... Continue reading
Posted Apr 22, 2016 at Policy and Medicine
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Newly appointed Commissioner of Food and Drugs Robert M. Califf, M.D., recently wrote an article on his goals for the Food and Drug Administration (FDA) during his tenure. The article goes through Dr. Califf's most important goal and responsibility, as... Continue reading
Posted Apr 21, 2016 at Policy and Medicine
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The recent revelations by Cyber Security experts regarding the significant vulnerabilities of medical devices to so-called "MedJack" attacks, has prompted the FDA to take proactive measures. This article highlights the issue of medical devices and Cybersecurity, address the comprehensive regulatory... Continue reading
Posted Apr 21, 2016 at Policy and Medicine
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Opioid abuse has been in the news for the past few months, and it seems as though it will continue to be in the news for awhile. Late last week, on April 14, 2016, three high-level officials at the Food... Continue reading
Posted Apr 20, 2016 at Policy and Medicine
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Recently, the Centers for Medicare & Medicaid Services (CMS) held a National Provider Call on Open Payments: Program Overview and Prepare to Review Reported Data. Robin Usi and Erin Skinner took turns educating participants how to identify the parts of... Continue reading
Posted Apr 20, 2016 at Policy and Medicine
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Lo n - FDA's Off-label The new decision in United States v. Vascular Solutions, Inc., provides the third point in a curve of the FDA's regulation of off-label promotion. This article provides a detailed explanation of the case, including the... Continue reading
Posted Apr 19, 2016 at Policy and Medicine
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Public Citizen updated that report, and issued a new report, which included settlements for all years, starting in 1991, through 2015. This new report found that there was a nearly eighty percent drop in settlements between companies and state governments... Continue reading
Posted Apr 19, 2016 at Policy and Medicine
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Late last week with only a photo attachment, the District of Columbia Department of Health announced to the pharmaceutical industry that the District is changing its gift reporting requirements to meet the requirements with the new Open Payments reporting. Chapter... Continue reading
Posted Apr 18, 2016 at Policy and Medicine
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For the past three years, the Centers for Medicare and Medicaid Services (CMS) has worked to align quality measures across different public programs in an attempt to support consistent high quality care for patients and to reduce complexity and burden... Continue reading
Posted Apr 18, 2016 at Policy and Medicine