DOJ Mallinckrodt in Hot Water: Tries to Reach Settlement, Gets Hit With New… Thomas Sullivan Jun 20, 2019 0 01On June 5, 2019, the United States Department of Justice (DOJ) announced that it filed a complaint under the False Claims Act…
Congress Senate Health Subcommittee Releases Discussion Draft of Legislation to… Thomas Sullivan Jun 19, 2019 0 Senate Health Committee Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA) released bipartisan discussion…
BioSimilar FDA Final Guidance on Demonstrating Biosimilar Interchangeability Thomas Sullivan Jun 18, 2019 0 The FDA issued a final guidance on the pathway for interchangeable biosimilar drugs. The guidance is intended to assist sponsors…
Opioids McKesson Settles West Virginia Opioid Distribution Lawsuit, But the… Thomas Sullivan Jun 17, 2019 0 McKesson Corporation agreed to pay $37 million to settle a lawsuit by the state of West Virginia alleging that McKesson willfully…
CME Rockpointe Study Quantifies Impact of CME on AFib Treatment, Prompts New… Jason Thomas Jun 16, 2019 0 A recent study by Rockpointe demonstrated the value of CME to atrial fibrillation (AFib) patients and the physicians who treat…
Congress Biopharma Executives Answer Senate Finance Committee Questions on Policies… Thomas Sullivan Jun 14, 2019 0 During the Senate Finance Committee hearing earlier this year addressing Drug Pricing in America, the committee posed questions to…
Congress House E&C Panel Republicans Push Back on Drug Transparency Bills Thomas Sullivan Jun 13, 2019 0 The House Energy and Commerce Health Subcommittee held a hearing on improving drug pricing transparency and lowering prices for…
CMS CMS Announces Medicare Part D Final Rule Maintaining Current Policy on Six… Thomas Sullivan Jun 12, 2019 0 The Centers for Medicare and Medicaid Services (“CMS”) announced a final rule maintaining the existing policy on coverage of drugs…
Uncategorized Minnesota Supreme Court Expands Medical Malpractice Liability Outside of… Thomas Sullivan Jun 11, 2019 0 The Minnesota Supreme Court issued an opinion in Warren v. Dinter. At issue was whether a physician-patient relationship is a…
ACCME ACCME Publishes Responses to Its January 2019 Call for Feedback Thomas Sullivan Jun 10, 2019 0 In January 2019, the Accreditation Council for Continuing Medical Education (ACCME) issued a call for feedback to review the rules…