New studies from Oregon State University say that the U.S. Food and Drug Administration (FDA) is approving new drugs faster than before.
The research shows that many drugs, especially those for diseases like cancer, get approved with fewer studies backing them.
In the past, the FDA would often use multiple clinical trials to decide if a drug was safe and effective. Now, many drugs are getting approved based on just one study.
The researchers believe that while speeding up approvals can help patients, there needs to be more openness about how these decisions are made.
This is important because sometimes the studies that are made public are not the only ones that were done.
For example, a company might have carried out five studies but only shared the results of two. So, what happened in the other studies?
The Change: The 21st Century Cures Act
The shift in how the FDA approves drugs started after the 21st Century Cures Act was passed in 2016. This law aimed to speed up the approval of new drugs so that patients could get potentially life-saving treatments more quickly.
Because of this law, the FDA relaxed some rules. Now, they allow some drugs to be approved with less strict types of studies.
For instance, instead of waiting for long-term results on whether a drug helps avoid heart attacks, the FDA might now approve a drug if it simply lowers blood pressure.
The studies reviewed FDA approvals for new drugs in 2017 and 2022. Researchers found that of the 37 new drugs approved in 2022, 24 (or about 65%) were based on just one study.
This was a big change from 2016 when only 20% of new drugs were approved based on one study.
What the Public Doesn’t Know
The researchers also checked a public database called ClinicalTrials.gov, which helps people learn about drugs they may be prescribed. They found that only a small fraction of studies are made public here.
For example, for drugs approved in 2022, only about a quarter of the available studies were posted for the public to see.
When the FDA approves a drug based on only a couple of studies, it’s not clear why those specific studies were picked and what the other studies showed. The public deserves to know the whole story, researchers argue.
Veronica Irvin, an associate professor at Oregon State University, said that they aren’t arguing for more studies, just more transparency. “We want doctors and patients to be able to see the whole picture,” she explained.
The message from these studies is simple: while getting new treatments to patients quickly is important, the process should also be as transparent as possible.
This way, both doctors and patients can make better-informed decisions about treatment options.
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The study was published in Health Affairs Scholar.
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