Hart Health Strategies provides a comprehensive policy briefing on a weekly basis. This in-depth health policy briefing is sent out at the beginning of each week. The health policy briefing recaps the previous week and previews the week ahead. It alerts clients to upcoming congressional hearings, newly introduced bills, regulatory announcements, and implementation activity related to the Patient Protection and Affordable Care Act (PPACA) and other health laws.


Updated Discussion Draft to be Released this Week

House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) and Rep. Diana DeGette (D-Colo.) are close to the completion of a new discussion draft for the 21st Century Cures Initiative. The bipartisan Initiative spearheaded by Rep. Upton and Rep. DeGette is aimed at accelerating the pace at which medical treatments and devices are discovered, developed, and delivered to patients. The first Cures discussion draft was released by Chairman Upton in January of this year and focused on potential improvements to the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). Since release of the first draft, Rep. Upton and Rep. DeGette have met with other members of the Energy and Commerce Committee, including Ranking Member Frank Pallone (D-N.J.), Health Subcommittee Chairman Joe Pitts (R-Pa.), and Health Subcommittee Ranking Member Gene Green (D-Texas), to help advance the legislation. The first Cures discussion draft was not endorsed by either Rep. Pallone or Rep. DeGette. The latest draft will be released prior to the 21st Century Cures Initiative hearing scheduled for Thursday of this week, exactly one year since the launch of the Initiative. Dr. Kathy Hudson, Deputy Director for Science, Outreach, and Policy at the NIH, Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at FDA, and Dr. Jeff Shuren, Director of the Center for Devices and Radiological Health (CDRH) at the FDA will testify. The latest draft will not be a completed bill, but rather an indication of the provisions that could be included in a final bill. The draft will be indicative of whether or not further action on the Initiative will be possible within the Chairman’s projected timeline. Rep. Upton has expressed hopes for passage of final legislation before Memorial Day. Acting Commissioner of the FDA Stephen Ostroff, M.D. commented that the 21st Century Cures package could be complementary to user fee discussions at his agency that will begin in June. Dr. Ostroff noted that the FDA approved a record 52 medicines last year, but new unfunded mandates from Congress through the 21st Century Cures Initiative could slow this progress.

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