The Senate HELP Committee unanimously approved seven bills last week as part of its biomedical innovation agenda, the upper chamber’s piecemeal version of the House’s 21st Century Cures Bill passed in July 2015.
The approval marks the first step toward creating a Senate counterpart to the House 21st Century Cures Act. However, the Senate version is introducing legislation in three different markup sessions rather than one measure.
Six of the bills passed by the committee affect devices and research: the FDA Device Accountability Act of 2015 (S. 1622), the Next Generation Researchers Act (S. 2014), the Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act (S. 800), the Advancing Research for Neurological Diseases Act of 2015 (S. 849), the Preventing Superbugs and Protecting Patients Act (S. 2503) and the Improving Health Information Technology Act (S. 2511).
Sen. Richard Burr (R-N.C.) introduced S. 1622. JC Scott, AdvaMed’s senior executive vice president of government affairs, says the legislation includes reforms that aim to improve the agency’s medical technology review process.
“Specifically, the bill will require additional training and oversight so FDA reviews are done efficiently and expeditiously; allow device clinical trial sponsors to use a central institutional review board to facilitate multi-center trials; and improve the CLIA-waiver process to accelerate the availability of point-of-care, rapid diagnostic information to physicians and patients,” he says.
S. 2511, introduced by Sen. Lamar Alexander (R-Tenn.), improves federal requirements relating to the development and use of electronic health records.
The second of three markups is scheduled for March 9, when five more biomedical innovation bills will be considered. They include 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) and The Advancing Breakthrough Medical Devices for Patients Act of 2015 (S. 1077).
A third and final markup is slated for April 6 to complete the Senate’s version of the measure. It is unclear whether the measure will come to the Senate floor as one bill or individual bills. — Michael Cipriano and Jonathon Shacat