The US Senate has passed the 21st Century Cures Act in a rare show of bipartisan unity by a vote of 94-5. President Obama has vowed to sign the bill once it reaches his desk.
Supporters of the legislation say that the bill will revolutionize healthcare and provide much needed assistance to consumers. According to NBC News, “It pays for cancer research, pays to fight the epidemic of opioid abuse, funds mental health treatment, helps the Food and Drug Administration to speed up drug approvals and pushes better use of technology in medicine.”
What the fawning news piece didn’t mention is that it’s a huge early Christmas present for big pharmaceutical companies. “It is sorely disappointing that Congress gave Big Pharma and the medical device industry an early Christmas present by passing the 21st Century Cures Act,” Dr. Michael Carome of the watchdog group Public Citizen said in a statement. “This gift – which 1,300 lobbyists, mostly from pharmaceutical companies, helped sell – comes at the expense of patient safety by undermining requirements for ensuring safe and effective medications and medical devices.”
At a time when drug and medical device companies should be under more intense scrutiny for marketing bad drugs and defective medical devices, this bill gives them free rein to continue their unscrupulous behavior. The bill allows the FDA to use less scientifically rigorous research, fewer clinical trials — which are expensive for Big Pharma — and use “real world evidence” to approve drugs. For example, the FDA could approve cancer drugs based on evidence such as tumor size, rather than on survival or death rates, the Wall Street Journal reported.
Part of the bill also allows drug makers to promote off-label uses — uses not approved by the FDA — of their products to insurance companies.
Republican U.S. Rep. Mike Fitzpatrick of Pennsylvania remarked “The 21st Century Cures Act will help accelerate the discovery and development of new treatments for patients…However, I voted against the bill because it fails to protect patients against dangerous medical devices.”
This is not good for the American consumer who deserves better from elected officials.