All posts by Vince Sampson

Washington Update: Senate proceeds towards “Cures”; CMS releases MA rates and Call Letter

Health care policy issues continue to stream out of Congress and the Administration.  The Senate held a markup of  various health bills as part of its effort to produce a companion to the House of Representatives-passed 21st Century Cures legislation and CMS released long awaited Medicare Advantage rates.

Heath Provisions in President’s Budget Take Aim at Drug Prices and Opioid Abuse

Today, the President sent Congress the $4 trillion Fiscal Year 2017 Budget Proposal – his last while in office.  While the Budget on the whole is dead on arrival in the Republican-controlled Congress, there are provisions worth noting because of their current newsworthiness and possible reemergence in future policy debates.  Moreover, proposals directed at addressing the […]

Senator Calls on Med Device Leaders to Improve Cybersecurity

Late last week, Senator Barbara Boxer (D-CA) wrote to the leaders of Johnson & Johnson, GE Healthcare, Siemens USA, Medtronic and Philips USA, to “express serious concerns” about potential cybersecurity vulnerabilities in their medical devices.  From the letter, the rationale for selecting these companies is that together they “control more […]

Senate opts for “Step by Step” approach for innovation legislation

Tuesday, Senator Lamar Alexander (R-Tenn.), Chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee announced  that he will pursue a “step by step” approach to crafting major biomedical innovation legislation.  This is a marked departure from both the House-passed 21st Century Cures bill and the previously announced Senate plan.

Key Health-Related Provisions Tucked into Year End Spending Bill

Last week, Congress passed and the President signed into law the Consolidated Appropriations Act of 2016 (“the Omnibus”). This legislation contains both $1.1 trillion in government spending for FY16 as well as $650 billion in tax breaks. The Omnibus includes several health care related provisions, both on the funding and tax sides. This post highlights some of the more significant items.

Joining the Debate, Hillary Clinton Releases Plan to Curb Drug Prices

In the wake of the uproar about drug pricing, Hillary Clinton unveiled on Tuesday, a plan to address the rising cost of prescription drugs. The plan will focus on ending “excessive” profits, lowering out-of-pocket costs, encouraging greater competition from generics and biologics and leveraging Medicare to negotiate drug prices. To […]

Trend watch: First Amendment challenges to FDA promotional requirements continue

In the wake of Amarin Pharma’s victory in securing a preliminary injunction against the Food and Drug Administration’s (FDA) prohibition of off-label communication of Vacepa , Pacira Pharmaceuticals has filed a First Amendment challenge to the FDA’s attempt to restrict communications about its postsurgical pain drug, Exparel. Pacira’ s lawsuit, […]