The Senate Health, Education, Labor and Pensions Committee passed breakthrough medical device legislation, as well as combination products and digital health regulatory reform bills, on March 9 as part of the panel's effort to pass a broad-reaching biomedical innovation package this year.

In all, the committee approved seven health care bills at the recent hearing, following seven that passed through the committee in February. (See [A#01160215009].)

HELP Committee Chairman Lamar Alexander, R-Tenn., said he intends to bring a biomedical innovation reforms bill as wide-ranging as the 21st Century Cures Act, which was approved by the House last July, to the Senate floor this spring. (See Also see "'Cures' Bill Passes, As More Budget, Safety Debates Wait In The Wings" - Medtech Insight, 10 July, 2015..)

Alexander said March 9 that he plans to pull together more than 50 disparate pieces of innovation legislation into one package after a third committee markup session set for April 6. “It will become the most important bill signed into law this year,” the chairman said.

510(k)s Deleted From Breakthrough Device Bill

The committee approved the Advancing Breakthrough Medical Devices for Patients Act, also on March 9. Similar to a provision in the House Cures bill, it would create an accelerated development pathway for devices that address unmet needs. (See Also see "Senate Will Tackle Separate Device Reform Bills As Part Of Innovation Agenda" - Medtech Insight, 20 January, 2016..) But the HELP-approved language was modified from the House provision to attract more support.

The committee-approved measure removed 510(k)s from the proposed breakthrough program and made it more explicit that the program was limited to targeting life-threatening or debilitating conditions.

The breakthrough pathway would build on the FDA device center's already-established Expedited Access Pathway (EAP), which allows select investigational devices to benefit from enhanced collaboration with FDA reviewers and potential data shortcuts, including shifting more evidence collection to the postmarket phase. (See [A#01150413013].) The House bill would expand on the current EAP program in several ways, including by allowing 510(k) devices to qualify in addition to PMA and de novo devices, and by not explicitly limiting the program to devices that address a life-threatening or debilitating condition. (See Also see "Shortened ‘Cures’ Draft Retains Breakthrough Pathway, Device Reforms" - Medtech Insight, 29 April, 2015..)

The original S. 1077, introduced by Sens. Richard Burr, D-N.C., Michael Bennet, D-Colo., and Orrin Hatch, R-Utah, last April, matched the House version. But the final manager's amendment, approved by the committee and also including Joe Donnelly, D-Ind., as a cosponsor, removed 510(k)s from the proposed breakthrough program and limited the program to targeting life-threatening or debilitating conditions.

Sen. Tammy Baldwin, D-Wis., said she was able to support the bill because the amended version addressed “several concerns raised by constituents.” She added, “In this case, removal of the 510(k) section was instrumental.”

Funding Debate

But other senators expressed reservations about S. 1077. Two of the most vocal senators at the HELP markup, Sens. Patty Murray, D-Wash., and Elizabeth Warren, D-Mass, said their continuing support for S. 1077 was contingent upon the full Senate agreeing to give FDA additional funds so the agency might carry out the many responsibilities that the device reform bills will create.

“We simply can’t expand the FDA’s responsibilities without expanding its resources,” said Murray, who is ranking member of the HELP Committee.

Chairman Alexander said he was pushing the biomedical innovation package to be linked with a “short-term surge of funding for the National Institutes of Health,” with an eye toward advancing several broad-based initiatives that have been announced, including Precision Medicine Initiative, the cancer “moonshot” discussed in President Obama’s State of the Union address (See [A#01160215012]), and the neurotechnology-focused BRAIN initiative. (See Also see "Three Next-Gen Prosthetics Projects To Receive BRAIN Funding" - Medtech Insight, 10 February, 2015..)

With regard to funding, “I pledge to work with Senator Murray and other members of the committee to try to achieve a bipartisan consensus that will arrive on the floor at the same time as this innovation package does," Alexander said. "I know the innovation package is not likely to get 60 votes unless we have some sort of bipartisan way to have a surge in funding, mandatory funding, for NIH.”

But Sens. Murray and Warren argued it was crucial to add mandatory funding for both FDA and NIH to support reforms, which would be accomplished through Warren's National Biomedical Research Act, introduced on March 3. Warren called the bill up as an amendment during the March 9 committee hearing, but later withdrew the amendment promising to bring it up on the Senate floor.

"Any package of innovation bills coming out of the HELP Committee must include significant increases in funding for NIH and FDA," Warren stated in a March 3 release. "Anything less is just lip service.”

Murray said Warren’s bill “has the support of every HELP Democrat.”

Sens. Murray and Warren said they would not support the innovation package on the Senate floor unless additional funding for FDA is part of the deal.

Alexander, however, repeatedly told the committee at the markup that his “surge of funding” plan was solely directed at NIH.

“[Additional funding for] FDA is a different kettle of fish, and for NIH, it’s about research, while at FDA – it’s for personnel,” the chairman told a group of reporters after the hearing.

“In my thinking, what we should do is gradually increase the regular annual appropriation for NIH every year. And the surge of funding is for specific products that would have a beginning, and an end, and not create a cliff. For example, the Precision Medicine Initiative – that might take five years, you might spend $2 billion, and then that’d be done.”

Combo Products, Digital Health Reforms

Another piece of legislation approved by the committee is the Combination Products Innovation Act of 2015, S. 1767, sponsored by Sens. Johnny Isakson, R-Ga., Bob Casey, D-Pa., Pat Roberts, R-Kansas, and Indiana’s Donnelly.

Multiple provisions of the bill are intended to streamline the combo products review process, including pushing FDA not to designate a combination product as having a drug primary mode of action without sufficient justification, and allowing FDA to take into account prior findings of safety and effectiveness of components of a combination product. (See Also see "Senate Bill Aimed At Streamlining Combo Product Regulation" - Medtech Insight, 20 July, 2015..)

The bill fits with a growing push by FDA and industry for reforms to the combo products review process. But FDA has said it plans to issue its own legislative proposal for reforms, possibly by later this year, with the potential for the changes to be coordinated with user-fee reauthorization in 2017. (See Also see "2016 Will Be A Big Year For Combo Product Reform, FDA Says" - Medtech Insight, 29 December, 2015..)

HELP also moved The Medical Electronic Data Technology Enhancement for Consumer’s Health Act, S. 1101, sponsored by Sens. Bennet and Hatch, forward. The MEDTECH Act would limit FDA's authority to regulate health software tools, leaving the agency to focus on software intended to acquire or analyze a medical image or a signal from an in vitro diagnostic device, a pattern or signal from a signal acquisition device, or other software that FDA formally notifies the public about and proposes to regulate.

"We very much like the line that the MEDTECH act draws," the Clinical Decision Software Coalition’s Bradley Thompson says.

Outside of FDA's scope would be software that:

provides administrative support for a health care facility;
is intended for maintaining or encouraging a healthy lifestyle;
serves as electronic patient records, with exceptions;
simply transfers, stores, converts formats or displays of clinical lab tests, or other device data and results;
displays, analyzes or prints medical information;
supports or provides recommendations to a health care professional about prevention, diagnosis or treatment of a disease;
enables health care professionals to independently review the basis for software-based care recommendations.

"We very much like the line that the MEDTECH act draws," said Bradley Thompson, who represents the Clinical Decision Software Coalition, an industry group that supports the bill.

Also approved by the committee March 9 was the Medical Countermeasures Innovation Act, S. 2055, focused on fighting bioterrorism threats, as well as bills targeting pediatric drug development, drug and vaccine development for Zika virus and legislation to improve engagement by patients and families in the FDA approval process.

More bills will be considered on April 6.

Senate Panel Passes Breakthrough Device, Other Measures; FDA Funding Debated

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