The House Energy and Commerce Committee unanimously approved H.R. 6, the “21st Century Cures Act,” on May 21, 2015, after reaching a bipartisan agreement to fund the legislation (Cures bill). Often described as a “landmark medical innovation” bill, key provisions of the Cures bill are intended to speed marketing approval of drugs and medical devices.
For example, with respect to drug products, the legislation would allow approval of certain drugs based on early-stage clinical trial results, allowing use of surrogate markers in clinical trials, and providing more efficient review of applications for additional indications. Additionally, the Cures bill would mandate U.S. Food and Drug Administration (FDA) consideration of patient experience data in the approval process.
For medical device products, the Cures bill would provide for priority review for breakthrough medical devices, a pathway for allowing certain modifications to cleared medical devices without supplemental 510(k) submissions, and expansion of the humanitarian device exemption. The legislation would also mandate issuance of multiple device-related guidance documents, with topics ranging from third-party quality audits to review of combination products.
Among other notable provisions in the Cures bill is one that would exempt drug and device manufacturers from reporting payments made to physicians for continuing education activities under the Physician Payments Sunshine Act. Another would allow the FDA to raise salaries of its “highly qualified scientific, technical or professional personnel” (e.g., biomedical researchers, reviewers) up to the salary level of the president of the United States. A third would provide Medicare reimbursement incentive to transition from traditional X-ray imaging (i.e., film based) to digital radiography. A fourth would exempt funds collected through user fee payments from sequestration.
As to funding, the Cures bill would provide $10 billion over the next five years to the National Institutes of Health, as well as $550 million in additional funds for the FDA. Funding would come from both the sale of crude oil from the Strategic Petroleum Reserve and the reduction of the amount of Medicaid reimbursement states receive for the purchase of certain durable medical equipment to the Medicare reimbursement rate.
A vote on the Cures bill by the House of Representatives is expected this summer. The full Senate is not expected to vote on the legislation until the end of the year.
As this summary cannot comprehensively cover all of the provisions included in the Cures bill, please direct any inquiries or comments on this legislation to Lance Shea.