Concerns with the 21st Century Cures Act

  • Allows anecdotal/unreliable and easily manipulated sources of health data to be used to approve new drugs. 
  • Encourages smaller, shorter term studies that are less likely to accurately measure the safety and effectiveness of new medical products.  Smaller studies are a step backwards for health experts who believe that new treatments should be proven safe and effective for women as well as men, people of color as well as whites, and adults of all ages, including those over 65.
  • Weakens the Physicians Sunshine Act, which requires pharmaceutical and device companies to publicly report when they provide funding or gifts to physicians.
  • Weakens patients safety by lowering standards of scientific evidence required to prove that new drug treatments and new medical devices are safe and effective.
  • Allows companies to disseminate “scientific information” that may not be accurate and was not scrutinized as part of the FDA approval process.  This opens the door for widespread use of medications for treatments not approved by the FDA. (Facilitating responsible communication of scientific and medical developments.)
  • Exempts potentially life-saving medical software from FDA review.  Reduces FDA’s authority to regulate electronic health records systems and other medical software.   Research shows that health IT software that is defective have caused deaths and permanent harm before the defects are discovered and corrected.

General Comments

This bill greatly benefits the pharmaceutical industry and medical device manufacturers.  Patients and researchers like that it promises to provide additional funding for the National Institutes of Health, the FDA, and opioid programs, but the bill does not guarantee that those promises will be fulfilled.

By lowering standards for drugs and devices, it is likely to add billions to the cost of Medicare and all health programs without benefiting most patients.  And it is an added burden on patients and physicians, because they need to decide which of the new treatments to try, without knowing if they are safe or effective.

For additional information, contact Jack Mitchell at the National Center for Health Research at (202)223-4000 or