The US Food and Drug Administration (FDA) on July 28th released draft guidance, Request for Quality Metrics, detailing plans to use quality metrics data to further develop the FDA's risk-based inspection scheduling, to identify situations in which there may be a risk for drug supply disruption, to improve the efficiency and effectiveness of establishment inspections, and to improve FDA's ev…

  The Bipartisan Policy Center has released a new report with recommendations designed to spur innovation by reforming FDA policies with several proposed reforms aligned closely with the 21st Century Cures legislation, Inside Health Policy reports. The report acknowledges the need for more robust resources at NIH and FDA, but does not make a formal recommendation about funding. The authors hope…

  On July 8th, the full House Appropriations Committee approved the fiscal year (FY) 2016 Agriculture Appropriations Bill by a voice vote. The bill provides a total of $20.65 billion in discretionary spending for FY 2016, $175 million (1%) less than FY 2015 enacted levels and $1.135 billion below the President’s request. Included in this total, the bill provides $1.194 billion for the Agricultural…

  President Obama has asked the US Senate to confirm Andy Slavitt as Administrator for the Centers for Medicare & Medicaid Services (CMS). Slavitt joined CMS in 2014 after serving as Vice President of UnitedHealth Group Inc., a company hired to fix the problems and turmoil surrounding the launch of the HealthCare.gov website, and has been acting administrator since the resignation of Marilyn …

  OSTP Director Dr. John Holdren last week issued a memo outlining the science and technology priorities for the Administration’s last budget cycle. The OSTP, in partnership with the Office of Management and Budget (OMB), advisees the President on the Federal Research and Development (R&D) budget and shaping R&D priorities across those Federal agencies that have significant portfolios in s…

  In a 344-77 vote July 10th, the House of Representatives passed H.R.6, the 21st Century Cures Act, a bill that ASPET has supported since its introduction last year. The legislation will provide NIH an additional $9.3 billion in mandatory funding over the next five years and establish a Cures Innovation Fund to support breakthroughs in biomedical research, as well as $550 million in added fundi…

  House Appropriations Advances First Labor-HHS Funding Bill in Six Years In a 30-21 vote following a nearly seven hour markup, appropriators advanced a $153 billion bill last Wednesday funding the departments of Health and Human Services (HHS), Education and Labor for the next fiscal year. This marks the first time in six years the full committee has advanced a funding measure for these depa…

  The National Institutes of Health recently announced the appointment of eight individuals to the NIH Council of Councils. The CoC was established to advise the NIH Director on policies and activities of the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), including making recommendations on areas of emerging scientific opportunities, public health challenges, or ar…

   The House Energy and Commerce Committee unanimously approved H.R.6, the 21st Century Cures Act, on May 21. The revised legislation incorporated many of the previously submitted comments and suggestions from the Federation of American Societies for Experimental Biology (FASEB) and others in the research community, including ASPET. Significant changes from the first to the fifth drafts…

  National Institutes of Health Director Dr. Francis S. Collins recently approved a federal report that lays out the long-term scientific vision for the NIH’s National Library of Medicine (NLM), the world’s largest biomedical library. This vision, presented today last week at the 110th meeting of the Advisory Committee to the Director (ACD), calls for NIH to position the NLM as a unifying force in…