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CCTS Newsletter | August 3, 2018

Friday, August 3, 2018   (0 Comments)
Posted by: Andres Bachelet
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Dale Dirks and Dane Christiansen

August 3, 2018


Prior to adjourning for the August recess, the House Energy & Commerce Committee’s Subcommittee on Health held a hearing on the implementation of the 21st Century Cures Act. The witnesses testifying before the Subcommittee were the NIH Director, Dr. Francis Collins, and the FDA Commissioner, Dr. Scott Gottlieb. Both the Subcommittee members and the witnesses touted the success of “Cures” during their remarks. In particular, the dedicated additional funding for flagship initiatives at NIH (the Cancer Moonshot, the Precision Medicine Initiative, the BRAIN Initiative, and Regenerative Medicine) provided by Cures was identified as a major driver of progress. For FDA, flexibility in clinical trial design and advancement of the Patient-Focused Drug Development Initiative were discussed as notable highlights during the hearing.


The Senate did not adjourn for the traditional summer recess period and is staying in session to make progress on a number of outstanding items. The legislative agenda outlined by Senate leadership for the next few weeks includes passing the chamber’s Fiscal Year (FY) 2019 appropriations bills in a series of minibus packages. In this regard, the Senate recently passed “minibus 2,” which included the spending bills for FDA, the Department of Transportation, and the Environmental Protection Agency. For many agencies and programs, the Senate-passed bills continue the recent trend of incremental funding increases coupled with an absence of controversial policy riders. As an acknowledgement of the bipartisan and collaborative nature of the ongoing appropriations process, minibus 2 passed 92 – 6. The Senate’s FY 2019 Labor-HHS-Education spending bill is expected to be coupled with the Department of Defense spending bill later in August.


The leadership of the Senate Appropriations Committee has branded the bipartisan progress on annual spending bills as a “return to regular order.” However, as Congressional Republicans work to finalize FY 2019 appropriations, the White House continues to threaten forcing a government shut down when the new fiscal year begins on October 1st. Further complicating the legislative efforts of Congress was the administration’s recent promulgation of rules to allow the entry of bare-bones (non ACA compliant) health plans into the marketplace. On a policy level, the move has been decried by stakeholders across the spectrum as a further attempt to destabilize insurance markets, while on a political level the move will likely stimulate a great deal of debate and partisan maneuvering heading into the November elections.