HELP Committee Votes Out Seven Biomedical Innovation Bills
The Senate Health, Education, Labor and Pensions Committee 3/9 favorably voted out seven bipartisan bills on biomedical innovation. The committee’s action follows seven previous bills voted out 2/9 (see earlier story). The latest bills are intended to advance the development of treatments for Zika virus and children suffering from rare diseases, medical countermeasures for bioterror victims, the promising new field of combination products, and devices that help Americans stay healthy, such as Fitbits or Apple watches.
Sen. Elizabeth Warren (D-MA) introduced an amendment that reflected language in her earlier National Biomedical Research Act (see story) that would increase funding for targeted biomedical initiatives through a new, reliable funding stream supporting FDA and the National Institutes of Health (NIH). She complained about the set of republican “disjointed pieces of FDA policies without any agreement on research funding,” adding that she will not support any of the bills until there is bipartisan agreement to fund research at NIH and strengthen FDA. In the interest of facilitating promised conversations from committee leadership about funding, she withdrew the amendment.
The committee has worked on a bipartisan basis for over a year to develop pieces of legislation that will authorize the president’s Precision Medicine and cancer moonshot initiatives and serve as a companion to the House-passed 21st Century Cures legislation, HELP chairman Lamar Alexander (R-TN) said, adding that the committee will continue to work in a bipartisan manner to reach agreement on a short-term mandatory funding measure to boost high-priority research projects at the National Institutes of Health. “Because of our budget deficit,” he said, “we need to fund that new surge in mandatory funding by reducing existing mandatory funding. We can discuss these ideas in committee, but everything we’ve done in committee has had bipartisan support and we do not have a bipartisan consensus on how to do this.”
Alexander said the committee would work toward an agreement when the consolidated bill goes to the Senate floor. Another mark-up is scheduled 4/6 that will discuss up to 20 different bipartisan ideas, he added.
The bills that were voted out include:S. 1878, The Advancing Hope Act of 2015S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015S. 1101, The Medical Electronic Data Technology Enhancement for Consumers Health ActS. 2055, The Medical Countermeasures Innovation Act of 2015S. 1767, The Combination Products Innovation Act of 2015S. 1597, Patient Focused Impact Assessment Act of 2015S. 2512, Adding Zika Virus to the FDA Priority Review Voucher Program Act