The U.S. House, in a rare act of bipartisanship, voted 344-77 on July 2 in favor of the 21st Century Cures Act, which supporters say will speed the development and regulatory approval of medical breakthroughs. Critics say that speed would come at the expense of patients' safety.
The legislation would provide an additional $9.3 billion in mandatory funding over the next five years to the National Institutes of Health and establish a Cures Innovation Fund to support work toward breakthroughs in biomedical research. It also provides $550 million in added funding to the FDA over the same period.
A last minute amendment introduced by Rep. Brat (R-VA) was poised to derail passage of the entire bill. It proposed to shift NIH funding from mandatory to discretionary spending, and make the funding subject to yearly appropriation and authorization by Congress.
MichBio along with other state bioscience associations, BIO, PhRMA, AdvaMed, and MDMA, supported the legislation that was spearheaded by Michigan’s own Rep. Fred Upton, Chairman of the House Energy & Commerce Committee. If it becomes law, it would make the drug and medical device review processes more efficient and less cumbersome, reducing the costs of bringing products to market and ultimately lowering the cost of those therapies for patients.
The bill would allow the FDA to grant market approval to a drug with breakthrough designation based on its early-stage testing for safety and effectiveness. The drug's manufacturer would be required to conduct clinical trials to demonstrate safety and effectiveness after market launch. Medical device makers could apply for breakthrough designation too for products that treat conditions where no alternative exists or that significantly improve on approved therapies.
The focus now moves to the Senate, where the Health, Education, Labor, and Pensions (HELP) Committee has held four hearings over the past year on drug and device innovation. It plans to develop legislation by the end of the year.