In a 344-77 vote July 10th, the House of Representatives passed H.R.6, the 21st Century Cures Act, a bill that ASPET has supported since its introduction last year.

The legislation will provide NIH an additional $9.3 billion in mandatory funding over the next five years and establish a Cures Innovation Fund to support breakthroughs in biomedical research, as well as $550 million in added funding to the FDA over the same period.

ASPET has sent several letters of support for this bill as it has gone through several iterations, praising the legislation for alleviating regulatory roadblocks in the FDA review process and reducing costs to bring a product to market.

A key provision would allow the FDA to grant early market approval to a drug with breakthrough designation based on its early-stage testing for safety and effectiveness. Medical-device makers also would also be able to apply for breakthrough designation for products that treat conditions where no alternative exists or that significantly improve on approved therapies.

Prior to final passage, the House defeated (141-281) the Brat Amendment to convert the NIH Innovation Fund from mandatory to discretionary funding. The House also defeated an amendment to strike a provision in the bill that applies any policy riders included in annual spending bills to NIH or Food and Drug Administration (FDA) funds provided in H.R. 6.

Now attention shifts to passage in the Senate; stay tuned for updates in this space.