WASHINGTON — A Senate panel on Tuesday approved seven biomedical innovation bills, putting the legislative chamber on a path toward completing a companion bill to the landmark 21st Century Cures Act, which passed the House of Representatives in July.
“This is an important day, not just for this committee but for all Americans who stand to benefit from this exciting time in medical innovation and research,” said Senator Lamar Alexander, chairman of the Health, Education, Labor, and Pensions Committee, in an email after the session.
Alexander, a Tennessee Republican, stressed that the bills — designed to speed therapies for patients with rare diseases; ease the medical device review process; fund young scientists; prevent drug-resistant superbugs; and update electronic health record-keeping — were passed with bipartisan support. Indeed, the votes for all seven measures were unanimous.
These smaller biomed bills grew out of the committee’s yearlong work to develop a Senate sidekick to the 21st Century Cures Act, which proposed to streamline certain Food and Drug Administration requirements for putting new drugs and medical devices on the market. The House bill also gave the National Institutes of Health an increase of nearly $9 billion over five years, and provided the FDA $550 million over the same period to speed up drug development — provisions that were crucial for securing the support of Democrats, who were otherwise not willing to ease regulations.
But despite its tradition of bipartisanship, the Senate HELP committee has been unable to agree on a guaranteed boost for NIH funding, or on certain regulatory requirements for new drug approvals.
Trying to break the logjam, last month Alexander decided to split the draft Medical Innovation Act into parts, rather than try to continue to work on comprehensive legislation.
At that time — and again on Tuesday — Alexander said he hoped that by taking a step-by-step approach to vote on smaller medical innovation bills, for which there was bipartisan support, the committee could make progress, and work up to the more controversial issues. Ultimately, he said, the full Senate could then vote on a package to go to conference with the House.
Alexander also said that he would consider mandatory funding for what he called an “innovation projects fund.” Such a program, he said, would pay for a few high-priority initiatives over a limited time. Among those for which he advocates funding are the Precision Medicine Initiative, the National Cancer Moonshot, the BRAIN Initiative, and grants for young scientists.
Alexander explained that he would consider using mandatory funding to support them, but that the money might have to come out of existing mandatory funded programs.
“As a practical matter, there are not bipartisan ways to pay for an innovation fund through mandatory funding in this committee’s jurisdiction,” he said. “So we will deal with the innovation fund, and how to pay for it, when the bill comes to the floor.”
Whether it will get there is still in question.
“The need for strong biomedical innovation is urgent, and we should be honest here,” said Senator Elizabeth Warren, a Massachusetts Democrat, at the HELP committee hearing on Tuesday. “A handful of smaller targeted changes like we’re voting on today won’t get us where we need to be.”
Warren and her Democratic colleagues said they would not support bills that do not add money for the NIH.
“Democrats are willing to support reasonable changes to improve the FDA,” Warren said. “But if Republicans are determined to gut the agency under the guise of improving it, then get ready for a fight on this.”