On Wednesday, the U.S. Senate overwhelmingly passed the 21st Century Cures Act (the “Act”) by a vote of 94 to 5. Spearheaded by Michigan Representative Frank Upton, the bill now heads to President Obama who has promised to sign it. The Act is ambitious, and will impact a wide swath of the U.S. health care system. The Act provides, among other things:
- $4.8 billion over 10 years to support NIH research on precision medicine, neuroscience, cancer and regenerative medicine.
- $1 billion in state grants to increase opioid abuse prevention and treatment services, including prescription drug monitoring programs, training programs and treatment programs.
- Substantial changes to FDA regulations to accelerate the pace of bringing pharmaceuticals and medical devices to market.
- New obligations on the part of both FDA and industry stakeholders to implement the research initiatives and regulatory changes mentioned above.
- Other health care initiatives addressing health information technology, vaccines, national security and health care delivery.
At 996 pages, the Act cannot be summarized in one post. Instead, we plan to analyze the various aspects of the Act in multiple posts over the coming weeks. The remainder of this post will highlight provisions that support one of the Act’s primary objectives: the acceleration of drugs and devices to market. Continue Reading Senate Passes 21st Century Cures Act, but Can It Cure an Ailing FDA?