NIH

News & Analysis as of

DOJ Files FCA Complaint Against Recipient of Grant Funding

The FCA began as a response to procurement fraud by military contractors during the Civil War. In the intervening years, its reach has extended and increasingly the government is using the FCA as a tool in the context of...more

USP Says European Market Shows Mandatory USP Standards Would Improve Biosimilar Approval, Acceptance in U.S.

Back in March, 2016, the Senate added language to the FDA and NIH Workforce Authorities Modernization Act which would exempt biological products, including biosimilars, from provisions of the FDCA Act that require compliance...more

Once again, retained rights in federally funded, patented drugs will not be asserted to control price

In a previous alert, "What you need to know about retained rights in federally funded patented drugs" (March 24, 2016), we provided background on the US Department of Health and Human Services' and the National Institutes of...more

NIH Signals “Paradigm Shift” with Policy on Multi-Site Studies

Federally-funded clinical trials conducted at multiple sites will move to a single Institutional Review Board (IRB) review scheme under a new National Institutes of Health (NIH) Policy. The NIH has finalized its policy to...more

White House Finalizes Data Security Framework For Precision Medicine Initiative

On May 25, 2016, the White House unveiled the final data security framework for its Precision Medicine Initiative (“PMI”). One of the main goals of PMI is to develop a research cohort for collecting health data from...more

NFL tries to pull a fast one on funding for head-trauma research

What’s $30 million among friends? When the National Football League offered in 2012 to provide that sum to support concussion research by the National Institutes of Health, the conventional wisdom held that the sports...more

NIH takes stronger steps to improve patient safety at Bethesda Clinical Center

Federal officials have decided to sweep out the executive ranks at the flagship hospital of the National Institutes of Health in Bethesda, this after a blue-chip investigating committee rebuked the institution and declared...more

DOJ Files IPR Petitions Against Discovery Patents

The U.S. Department of Justice (DOJ) filed six petitions for inter partes review (IPR) of three patents assigned to Discovery Patents, LLC. The patents cover security alarm systems and methods for providing secure real-time...more

Senate HELP Committee Completes Work on Bipartisan “Cures”/Medical Innovation Legislation

The Senate Health, Education, Labor and Pensions (HELP) Committee has approved the last of its biomedical innovation bills that form its counterpart to the House 21st Century Cures Act. Together with the bills cleared by the...more

Members of Congress Seek NIH Hearing on Use of March-in Rights

On March 28, 2016, a dozen members of Congress sent a letter to Sylvia Mathews Burwell, the Secretary of the Department of Health and Human Services, and Dr. Francis Collins, the Director of the National Institutes of Health...more

Senate HELP Committee Convenes Third and Final Cures Markup

On April 6, 2016 the Senate Committee on Health, Education, Labor, and Pensions (HELP) will hold its third and final markup for its biomedical innovations package. This package is a compliment to the House-passed 21st Century...more

Blog: 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...more

FDA Regulatory and Compliance Monthly Recap — March 2016

FDA warning letter calls out exoskeleton device manufacturer for repeatedly avoiding FDA requests for postmarketing surveillance - The FDA sent a warning letter to Argo Medical Technologies after the company averted...more

Washington Healthcare Update

This Week: The House of Representatives and the Senate were on recess…but it was not quiet on the health care front! 1. Congress - House of Representatives - House, Senate Democrats Want NIH to Bring Down...more

What you need to know about retained rights in federally funded patented drugs

The issue of drug pricing is top of mind - More than 50 members of Congress, led by Rep. Lloyd Doggett (D-TX), sent a letter to Secretary of Health and Human Services Sylvia Matthews Burwell and to National Institutes of...more

Washington Healthcare Update

This Week: Medicaid program takes financial hits as the House looks for “savers” and acts on a budget... while the Senate sees no reason to do a budget... The Senate focuses on ACA oversight and mental health and opioid abuse...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On March 15, 2016, the Centers for Disease Control and Prevention (CDC) issued voluntary guidelines entitled, “CDC Guidelines for Prescribing Opioids for Chronic Pain — United...more

Washington Healthcare Update

This Week: Drug pricing remains a focus as CMS rolls out a demonstration project for Part B drugs... The Senate passes The Comprehensive Addiction and Recovery Act (CARA) and Senate Cures legislation moves forward... Senate...more

Washington Healthcare Update

This Week: The President took a victory lap in Wisconsin, announcing that 20 million people have gained health insurance through the Affordable Care Act... That figure includes people newly covered through insurance...more

Capitalizing on Collaboration – The President’s Precision Medicine Initiative

Last week President Obama marked the one year anniversary of his Precision Medicine Initiative (“PMI”) by holding a web-accessible panel discussion where he and interested stakeholders discussed his PMI initiative, its...more

Washington Healthcare Update

This Week: The House and Senate were out for Presidents’ Day recess... The Senate to vote on FDA Commissioner nominee Califf after 5:30 today... Medicare Advantage rates announced....more

Representatives Send Letter to HHS and NIH Seeking Response to Pharmaceutical Costs

In a letter sent earlier this month to Secretary Sylvia Mathews Burwell of the U.S. Department of Health & Human Services and Director Francis S. Collins of the National Institutes of Health, fifty members of the U.S. House...more

The President’s Precision Medicine Initiative – The First Annual Check-Up

Watching President Obama’s recent 2016 State of the Union Address reminded me that one year has passed since the President announced a new “precision” or personalized medicine initiative to advance personalized, effective...more

Washington Healthcare Update

This Week: The House is not in session this week... The Senate returns today... Committees in the Senate will hold hearings on co-ops and mental health... Vice President Biden will attend the World Economic Forum in...more

Blog: 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...more

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