When the U.S. House of Representatives approved the 21st Century Cures Act on July 10, the Food and Drug Administration’s (FDA) ability to protect consumers was one step closer to losing strength. The bill is currently awaiting U.S. Senate approval, but the FDA’s authority took a different hit when a federal district court judge ruled the agency’s off-label drug policy violated the free speech rights of pharmaceutical companies.
The 21st Century Cures Act would allow potentially dangerous medical devices to reach the market more quickly and with less proof of safety. The judge’s free speech ruling opens the door to allowing pharmaceutical companies to more easily market drugs without FDA approval.
