21st Century Cures Act Will Hasten Drug Approval
The 21st Century Cures Act has passed the House and Senate. It’s now headed to President Obama, who has pledged to sign it. The bill is a behemoth, packed with provisions and funding to address the opioid epidemic, mental health research, genetic medicine, and electronic health records. It includes Vice President Joe Biden’s signature “cancer moonshot,” aimed at new therapies and cancer vaccines. And it promises nearly $5 billion in funding over the next 10 years for the National Institutes of Health, the nation’s flagship biomedical research arm.
The act also gives the FDA more discretion on which drugs and devices to approve, by loosening regulatory standards and allowing “real-world evidence” and anecdotal data to stand in for the gold standard of medical tests, the randomized controlled trial. Patient advocates say the move will get life-saving new drugs to patients faster. But critics contend that looser regulations will only increase the number of unsafe and ineffective drugs that make it to consumers, which they say could be a costly—and dangerous—mistake.
Sydney Lupkin is a correspondent for Kaiser Health News in Washington, D.C..
John LaMattina is the former head of Pfizer R&D. He writes about the pharmaceutical industry at Forbes, and is the author of Drug Truths: Dispelling The Myths Of R&D (Wiley, 2008) and Devalued And Distrusted: Can The Pharmaceutical Industry Restore Its Broken Image? (Wiley, 2013). He’s based in Stonington, Connecticut.