The U.S. House of Representatives on Friday morning approved the 21st Century Cures Act by a wide 344-77 margin. The bill now heads to the Senate for consideration.

The bipartisan legislation is meant to streamline regulatory approval of devices and drugs through the Food and Drug Administration, as well as provide additional research funding for the National Institutes of Health.

Here are some highlights of the bill (H.R. 6) as of last week, though the version that passed may contain last-minute amendments that have yet not made it into the official legislative database:

Innovation fund: For the next five years, NIH would get $1.75 billion and FDA $110 million annually to address “major challenges” in biomedical research that could potentially lead to important breakthroughs. The bill’s authors say the new spending is fully offset with savings realized in other parts of the legislation.

NIH reforms: In addition to reauthorizing NIH operations for the next three fiscal years, the 21st Century Cures Act requires the agency to develop a strategic research plan, become more accountable in its awarding of grants and find ways of lessening the administrative burden on researchers and grantees. The bill also would promote more collaborative research and establish a national pediatric research network under NIH.

Precision medicine: FDA would have to define and later update as necessary the term “precision medicine or biological product.” FDA also would have the authority to approve treatments for rare and life-threatening diseases based on data submitted for previously approved products that takes a similar “underlying approach” to fighting the disease.

Patient access to “breakthrough” therapies: Congress directs the FDA to continue its policy of fast-tracking approval of “breakthrough” drugs and therapies, as long as the innovation meets established safety and efficacy standards.

Patient-centered drug development: The FDA would have to develop a “structured framework” that would incorporate patient observations and experiences into drug-safety evaluation.

Medical device regulation: The bill would authorize a third-party, voluntary quality assessment program for device-makers to have their quality systems pre-authorized, theoretically speeding up pre-market review. FDA also would be more lenient in its review and oversight of low-risk Class I or Class II devices, possibly opening the door to faster approval of diagnostic medical apps and other mobile devices. Another section is meant to provide more clarity about when smartphones and other wireless platforms would be considered medical devices.

Interoperability: In light of the Office of the National Coordinator for Health Information Technology finding rampant “information blocking” by certain health IT vendors, the bill gives the Department of Health and Human Services power to hold scofflaws responsible, in the name of creating data interoperability.

Home-based care: The legislation changes Medicare’s payment system for durable medical equipment to remove barriers to seniors receiving the same kind of care and access to medical devices in the home as they would in a hospital or skilled nursing facility.

Photo: House Energy and Commerce Committee