Policy and Legal

The 21st Century Cures Act of 2016 and its 2021 follow-on, Cures 2.0, are providing a pathway toward potentially groundbreaking cures and treatments—but there’s room for even more improvement in the federal government’s handling of pharmaceutical innovation, the NAM said this week.

Now, Reps. Diana DeGette (D-CO) and Larry Bucshon (R-IN) are looking to build on the legacy of these two bills.

The background: The 21st Century Cures Act, introduced in 2015 by Rep. DeGette and former Rep. Fred Upton (R-MI) and signed into law the following year, aimed to speed up the development and delivery of medical innovation.

• The 2016 measure “ensured that federal agencies like the [Food and Drug Administration], the Centers for Medicare & Medicaid Services and the National Institutes of Health had the tools they needed to keep pace with and adapt to the tremendous advances being made by biopharmaceutical and medical device manufacturers,” said NAM Vice President of Domestic Policy Charles Crain.
• Cures 2.0, passed after the global pandemic, created the Advanced Research Projects Agency for Health, “a home within the federal government for high-risk, high-reward medical research.”

New medical advances: The face of medical innovation “has changed dramatically” in the past eight years, Crain pointed out, as we’ve seen the first-ever federal approval of gene therapy and the development of vaccines using mRNA technology.

What’s needed: The new landscape necessitates more congressional action, Crain went on, including:

• Continuing to embrace the new technologies that emerged from the COVID-19 pandemic like mRNA and other innovations;
• Modernizing federal agencies such as the FDA to keep up with these innovations; and
• “[E]nsuring the government’s processes for reviewing and approving new treatments are as innovative as the treatments themselves.”

Why it’s important: Biopharmaceutical manufacturers are economic powerhouses. In 2021, they:

• Accounted for $355 billion in value-added output to the U.S. economy;
• Contributed a total of nearly 1.5 million direct and indirect jobs; and
• Contributed $147 billion in labor income.