21st Century Cures Act Stalls in Senate
By Jill Drachenberg, Managing Editor, AHC Media
The Senate will not consider the 21st Century Cures Act – sweeping medical legislation the House passed in July 2015. Instead, the Senate Committee on Health, Education, Labor, and Pensions will consider several smaller pieces of legislation with similar goals, according to a news statement from committee Chairman Lamar Alexander (R-TN).
The new bills are slated for committee discussion in February, March, and April for final markup on the bills. The February meeting will include the following:
- HELP Committee legislation to improve EHRs;
- The FDA Device Accountability Act of 2015 (S.1622);
- The Advancing Targeted Therapies for Rare Diseases Act of 2015 (S.2030);
- The Advancing Research for Neurological Diseases Act of 2015 (S.849);
- The Next Generation Researchers Act (S.2014);
- The Enhancing the Stature and Visibility of Medical Rehabilitation Research at the NIH Act (S. 800); and
- Legislation regarding FDA regulation of duodenoscopes.
Later meetings will include markup on the following proposed legislation:
- The Advancing Hope Act of 2015 (S. 1878);
- The Medical Electronic Data Technology Enhancement for Consumer’s Health (MEDTECH) Act (S. 1101);
- The Medical Countermeasures Innovation Act of 2015 (S. 2055);
- The Combination Products Innovation Act of 2015 (S.1767);
- The Advancing Breakthrough Medical Devices for Patients Act of 2015 (S. 1077); and
- Legislation to support the President Obama’s Precision Medicine Initiative and funding for the National Institutes of Health to research individualized treatments for patients.
According to coverage from the September 2015 issue of IRB Advisor, the act was intended in part to speed new medical devices and life-saving treatments to market for those with serious illnesses such as cancer and traumatic brain injuries. It also called for $8 billion in additional NIH funding. The act raised concerns from researchers and IRB experts due to a section that would have made possible a broad expansion of informed consent waivers for studies that pose “no more than minimal risk” to research subjects.
“With the Cures Act, we think the waiver will expand beyond extraordinary circumstances and that’s inappropriate,” Michael A. Carome, MD, director of the health research group at Public Citizen in Washington, DC, told IRB Advisor. “Expanding the waiver to research that involves no more than minimal risk violates the universal principle for respect of persons, and there’s no reason to do this; we don’t believe existing law has inhibited clinical trials that promote new drugs, so we see no reason to expand the waiver.”
The Cures Act passed the House last summer with rare bipartisan support, but stalled in the Senate over funding disagreements.