Congress returned to Capitol Hill last week to confront a series of high priority domestic and international policy issues that will dominate the fall legislative agenda. Funding government agencies beyond the end of the fiscal year on September 30 is at the top of the list, as Senate Majority Leader Mitch McConnell (R-KY) acknowledged in an interview on a Kentucky television program on Aug…

On August 24th, the FDA held a public meeting to discuss its plan to request quality metrics from drug manufacturers. The meeting was the first opportunity for the agency and industry to publicly discuss the plan since FDA released its draft guidance in July. The draft guidance, Request for Quality Metrics, details plans to use quality metrics data to further develop the FDA's risk-based inspecti…

  The White House Office of Management and Budget (OMB) recently announced that it is seeking feedback on ways to reduce unnecessary reporting burden for recipients of federal grants and contracts. Information will be collected through the “National Dialogue website” and used to inform a two-year pilot study and other activities. The Federation of American Societies for Experimental Biology (FA…

  Countdown to a showdown; Lawmakers return to Washington in just a few days with next year’s budget resting on the actions taken in the first legislative days. The House is up first and will have to pass a short-term funding bill to avoid a government shutdown. The Senate, scheduled to be in session for 17 days in September, will have a few more days to address any House-passed continuing resolu…

  On July 20, the National Institutes of Health (NIH) issued a draft framework for a five-year strategic plan. The new framework identifies three crosscutting areas of opportunity across biomedicine: promoting fundamental science, improving health promotion and disease prevention, and advancing treatments and cures. The plan also details two unifying principles or “mission priority focus area…

  Despite the House and Senate Appropriations Committees approving all 12 of their annual spending bills for the first time in six years, both legislative bodies have adjourned for summer recess without a budget agreement. In a July 14 press release, House Appropriations Committee Chairman Hal Rogers (R-KY) congratulated his committee on their achievement but noted that appropriators still have mu…

  The US Food and Drug Administration (FDA) on July 28th released draft guidance, Request for Quality Metrics, detailing plans to use quality metrics data to further develop the FDA's risk-based inspection scheduling, to identify situations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 …