By Teresa Carr, Consumer Reports: December 7, 2016
Congress has passed the most expensive and far-reaching health reform bill since the Affordable Care Act in 2010.
The 21st Century Cures Act, which garnered widespread, bipartisan support in both the House and Senate, is expected to be signed into law by President Obama soon.
The bill signifies an investment of billions of dollars over the next decade to fight cancer, prevent and treat brain disorders, and harness enormous amounts of data to develop individualized treatments based on a person’s environment, genes, and lifestyle.
But the bill also lowers the bar for the kind of scientific evidence that companies must provide to gain the Food and Drug Administration’s (FDA) approval for their products. It would mean, for instance, that in some circumstances the FDA could rely in part on individual patient experiences with a drug or device, instead of evidence from large-scale, randomized controlled clinical trials.
Faster Drug Approvals, But Lower Standards
The Cures Act loosens requirements for how drugs are studied and approved that have been in place since 1962.
Here’s how it usually works: A company submits evidence from studies done under controlled conditions, comparing patients who received the treatment with those who didn’t. The studies typically have to show that people who were given the new drug lived longer or felt better than those who didn’t get it.
This kind of research can be expensive and time-consuming for drug companies to collect, says Diana Zuckerman, Ph.D., president of the National Center for Health Research, a nonprofit think tank focused on health research. Cancer drugs, for example, can take several years to show that a drug improves survival.
The Cures Act calls on the FDA to approve some drugs more quickly, based on less thorough testing. The problem with this, says Zuckerman, is that “getting drugs to market faster doesn’t help consumers at all if they turn out not to work or causes them harm.”
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