A group of bipartisan lawmakers are on the brink of finalizing a new healthcare law that has lobbyists and the drug companies they represent excited. Called the 21st Century Cures Act, this piece of legislation will supposedly boost medical research and eradicate the valley of death for inventors, medical device makers, and healthcare companies.
Is the 21st Century Cures Act a Better Deal for Patients?
Combining more than $5 billion in funding, The 21st Century Cures Act will, according to NPR:
“The law would likely save drug and device companies billions of dollars when it comes to bringing products to market by giving the Food and Drug Administration more discretion in the kinds of studies required to evaluate new devices and medicines for approval.”
This bill was designed to speed up the approval process of new products – but consumer advocate organizations are worried that it undermines rigorous testing requirements.
Right now, if a company wanted to sell a particular product that treats more than one type of illness, then it must survive randomized trials that’ll show that the product does work for each separate illness.
This new law will compromise the rigorousness of these tests, and will enable the FDA to approve products independent of clinical trials.
Instead of a new product surviving randomized, controlled experiments, this new bill empowers companies to simply submit observational, nonscientific data from selected patients who are already using the drug.
The 21st Century Cures Act also threatens public health, as it will cut $3.5 billion from funds that promote health advocacy. Many consumer safety groups like the National Center for Health Research have also noted that this bill will only introduce unsafe drugs and device approvals, and doesn’t address the issue of rising drug costs.
More Like The 19th Century Fraud Act
Daniel Carpenter, a historian at Harvard University, has called out the bill, warning that relaxing FDA standards will only threaten patients, and American citizens. This new law will also provide the FDA a paltry $500 million, with it projected to not being adequate enough to help absorb the incoming workload.
The phrase “FDA Approved” has been mocked, threatened, and may not even be truthful anymore.