As women fighting life-changing autoimmune disease, allergies and more - one life threatening, two with illnesses and injuries caused by different FDA-approved medical and dental devices, and one a former FDA employee fighting chronic autoimmune disease of not yet known cause – we call for Congress to do more than pass a 21st Century Cures Act. Congress must also pass a 21st Century Medical Device Safety Act.
The House of Representatives passed the 21st Century Cures Act 392-26. It is on to the Senate for a vote. Its bipartisan leaders smartly loaded it up with some benefits for almost everyone – a total of $4.8 billion in research funding for the Brain Initiative, Precision Medicine Initiative, Cancer Moonshot, and provisions for mental health, opioid abuse, Lyme disease, and more. Representatives from Pharma, Biotech, and Chronic Disease Groups have stormed the halls of Congress to ensure this bipartisan bill is enacted. On the surface, it is a slam dunk. But look beneath the surface, and we have work to do.
Sen. Elizabeth Warren, D-Mass. made a strong speech to stop the bill and fix it, launching a MoveOn petition, “Tell Congress: Don't let Big Pharma hijack the 21st Century Cures Act,” which has gathered over 166,000 signatures in days. Sen. Bernie Sanders, I-Vt, called to rewrite the bill to lower prescription drug costs. A courageous band led by Rep. Mike Fitzpatrick, R-Pa., and Rep. Louise Slaughter, D-NY, have been pressing to address medical device safety, through calls for the passage of Ariel Grace’s Law, the Medical Device Guardians Act, and a reboot of FDA’s device regulations to ensure patient safety first.