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.


Upton Hopes to Formally Introduce This Month

House Energy and Commerce Committee Chairman Fred Upton (R-Mich.) and Rep. Diana DeGette (D-Colo.) have unveiled the second draft of the 21st Century Cures Initiative package and a section-by-section summary. Upton and DeGette launched the Initiative one year ago, with the goal of overhauling the government’s regulation of medical products. The nearly 200-page document updates and condenses the discussion draft released in January of this year, which was almost double in length. This latest draft was able to secure the support of Ranking Democrat Frank Pallone (D-N.J.), Health Subcommittee Chairman Joe Pitts (R-Pa.), and Health Subcommittee Ranking Member Gene Green (D-Texas). The previous version did not have the endorsement of any Democrats. The document organizes provisions according to the discovery, development, and delivery of medical breakthroughs at the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the Centers for Medicare and Medicaid Services (CMS), respectively. The draft retains language allowing for the expedited approval of breakthrough medical devices, vaccines, and antibiotics, the streamlining of clinical trials, and the establishment of disease registries. It makes further clarifications regarding the regulation of health software, and would help to further incorporate the patient perspective into the drug development process. The new document also includes additional details directing the FDA to provide guidance on the emerging field of precision medicine. A number of notable revisions were made to the first discussion draft in the latest document. The draft now includes a provision authorizing an additional $10 million in funding for an NIH innovation fund over the next decade. The bill would require the innovation fund to be put towards precision medicine or the funding of young scientific investigators. It would also authorize an additional $1.5 billion in discretionary funding during each of the next three years. This exceeds the President’s NIH budget request by more than $1 billion. The Committee has yet to determine how the funding increases will be offset, if at all. Measures to grant exclusivity periods for manufacturers of seldom-used therapies for unmet needs and for generic manufacturers as a protection from international competition have been removed from the document. The newest draft has also dropped a provision to reduce FDA-requirements related to the advertising and promotion of drugs on social media. Placeholder language has been included in the draft to give lawmakers a chance to further refine the issues of telemedicine, interoperability of electronic health records (EHRs), and the repurposing of drugs approved by the FDA for other uses. The Energy and Commerce Health Subcommittee held a hearing to discuss the draft legislation the day after it was released – the one year anniversary of the beginning of the 21st Century Cures initiative. During the hearing, members voiced support for the increase of funding for NIH, but questioned whether a similar funding boost would be necessary for the FDA to carry out the expanded responsibilities that would result from 21st Century Cures. Both Dr. Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health (CDRH) and Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research (CDER) expressed concerns that the timeliness of their agency’s routine tasks could be jeopardized if the FDA receives additional congressional mandates without an increase in resources. Members on both sides of the aisle stressed that they would continue to work to finalize a bipartisan legislative compromise. Chairman Upton hopes to formally introduce a 21st Century Cures bill in early May, and advance the bill to the House floor by June.

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