releases: https://butterfield.house.gov/media-center/press-releases/butterfield-applauds-passage-of-his-seven-priority-issues-in-the-21st
Data license: MIT · Data source: dwillis/congress-press
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| https://butterfield.house.gov/media-center/press-releases/butterfield-applauds-passage-of-his-seven-priority-issues-in-the-21st | Butterfield Applauds Passage of His Seven Priority Issues in the 21st Century Cures Act | 2015-07-10 | 2015 | 2015-07 | Democrat | House | NC | G. Butterfield | B001251 | butterfield.house.gov | legacy | WASHINGTON, DC Today, Congressman G. K. Butterfield (NC-01), member of the House Committee on Energy and Commerce and the Subcommittee on Health, applauded the passage of the 21st Century Cures Act, which included seven provisions co-authored by Butterfield. Among his several priorities included in the 21st Century Cures Act is the provision to reauthorize the Rare Disease Priority Review Voucher (PRV) Program run by the United States Food and Drug Administration (FDA) that incentivizes and fast-tracks much-needed pediatric drugs to market. The provision builds on the success of the Creating Hope Act of 2011, which was originally authored by Butterfield and Congressman Mike McCaul (R-TX) and passed into law in 2012 to create the PRV Program. In the past, high costs associated with developing pharmaceuticals for rare pediatric diseases have made pharmaceutical companies reluctant to develop treatments despite medical need. In addition, developing products for children was challenging because of the difficulties associated with conducting clinical trials on this patient population. Butterfield's provision, included in the 21st Century Cures Act, expedites drug approval by the FDA so long as they are used to treat rare pediatric diseases which includes any form of sickle cell disease and any pediatric cancers. Butterfield said, I applaud both my Democratic and Republicans colleagues for coming together to pass one of the largest and most comprehensive health research investment bills this Congress has ever seen. I have had the pleasure of working with my colleagues Representatives Renee Ellmers, Gus Bilirakis, and Mike McCaul on advocating for our shared interests, and I'm appreciative of the inclusion of all my priorities in the 21st Century Cures Act. Most importantly, this bill stands to benefit eastern North Carolinians and all Americans who face challenging medical conditions and need innovative treatments. I look forward to the Senate acting on this bipartisan legislation and seeing the Cures Act signed into law. The full list of Butterfield's priorities included in the 21st Century Cures Act are: The National Institutes of Health Innovation Fund (Section 1002): To support biomedical research through the funding of basic, translational, and clinical research for five years, FY2016 through FY2020. Expanded Access Policy (Sections 2082-2083): To place transparency requirements on certain drug companies regarding their expanded access programs (programs for patients to access drugs before they are approved) and require the Food and Drug Administration to finalize guidance regarding how it interprets and uses adverse drug event data resulting from drug use under such expanded access programs. Timely Review of Vaccines by the Advisory Committee on Immunization Practices; Review of Processes and Consistency of ACIP Recommendations; and Meetings between Centers for Disease Control (CDC) and Vaccine Developers (Sections 2141-2143): To create and formalize processes for the making of vaccination scheduling recommendations by the Advisory Committee on Immunization Practices (ACIP), for CDC review of the ACIP recommendations, and for meetings between CDC and vaccine developers. Extension of Exclusivity Periods for a Drug Approved for a New Indication for a Rare Disease or Condition (Section 2151): To provide incentives for drug companies to conduct research to repurpose approved drugs for rare diseases and seek approval from FDA for a rare disease indication on its label. Reauthorization of Rare Pediatric Disease Priority Review Voucher Incentive Program (Section 2152): To reauthorize the rare pediatric disease priority review voucher (PRV) program through December 31, 2018, and to require a Government Accountability Office report to evaluate the effectiveness of the program for incentivizing drug development for rare pediatric diseases. Health Software; Applicability and Inapplicability of Regulation; Exclusion from Definition of Device (Sections 2241-2243): To address concerns related to the current regulatory approach for health technologies through supporting further development in health information technology fields by updating the regulatory laws around software and creating clarity for developers and reviewers alike. Treatment of Certain Items and Devices (Section 3061): To authorize Medicare coverage of certain partially disposable and fully disposable products that may be accessed in the home setting. Currently, seniors who receive their care in a home setting are not able to access certain services afforded others because of the nature of the Durable Medical Equipment payment system. https://Butterfield.House.Gov ### | 1 | 2026-03-30T12:14:52Z | 2026-03-30T12:14:52Z |