Last December, the 21st Century Cures Act became law, opening the door to the assignment of greater federal funds for medical research and more expedient approval of medical devices and drugs by the Food & Drug Administration.
The Act directs the FDA to use "real world evidence" as well as random clinical trials when evaluating whether medicines and devices should be approved. "Data summaries," instead of full clinical trial results, can now be used to support approval of certain medicines. Drug makers are now allowed to promote off-label uses for medications to insurance companies. Critics of the Act say that it could risk rushing flawed drugs and treatments into the health care market; supporters applaud the Act for giving the FDA the potential to fast-track "breakthrough" devices and drugs. 2