The FDA's Drug Approval Process Is Worrisome

Scary news from the already-scary drug industry: Not all drugs approved by the FDA are tested equally, according to a recent analysis from two papers published Tuesday in the Journal of the American Medical Association. The papers describe themselves as the “first systemic analysis” of the agency, and the reports showed that while most new drugs are tested in “high-quality clinical trials,” up to one-third of all approved drugs are given the green light after just one study. And the conclusion both studies reach? Not all drug approvals are made equally.

Yale’s School of Medicine, which contributed one of the two studies, examined 188 drug approvals and trials spanning from 2005-2012 to reach that scary one-third statistic. They also found that some approvals were given to drugs that had only been tested for a “limited result” — a.k.a. it reduced the size of a tumor, instead of a “clinical endpoint,” such as making the patient live longer.

Furthermore, Yale found that only 40 percent of tested drugs were held up against drugs already on the market, meaning there could be a lot of duplicates out there — and not only that, but there are no studies examining how comparatively effective they are. This presents, potentially, a huge problem for doctors, who don’t have any solid data to go off of when deciding which drugs to prescribe for a certain condition: The thing most likely to sway their minds won’t be science, but pharma reps.

And it gets worse: One of the scariest findings of the study is that the majority of the drugs designed for long-term use — a.k.a. the rest of a patient’s life, like for diabetes or asthma — had been in trials that took place over six months or less.

"Some [drugs] are approved on very robust evidence, and some are based on preliminary evidence," co-author and Yale med assistant professor Joseph S. Ross said. "There is a lot of nuance at the time of approval that isn't well communicated to patients."

And it’s not just drugs that are complicit: Devices designed to be placed inside the body are also prey to the flexible standards.

These devices, which include implanted defibrillators that shock a faltering heart back into normal rhythm, go through rigorous review when they're first approved, says Aaron Kesselheim, author of one of the studies and an assistant professor at Harvard Medicine School. Subsequent changes, however, are often made through a "supplemental" review process that doesn't necessarily require them to be tested in clinical trials in humans, Kesselheim says…

"If you took a device approved 15 years ago and you put it side by side with the one from today, they might look nothing like each other," Kesselheim says.

In short, today's devices aren't tested to the same standards as their older incarnations.

The reason behind the fast-tracking has a lot to do with an ethical standard that’s hard to argue with, at least superficially: The FDA wants to get potentially life-saving drugs out on the market as quickly as possible.

“I think it’s reasonable to have a somewhat flexible standard of approval because in some cases there’s a great unmet medical need,” said study author Nicholas Downing. This is great in cases when there’s currently no drugs available to treat a certain condition, such as when AIDS first struck the mainstream and there wasn’t anything available on the market to treat it.

On the flip side, allowing drugs to enter the competitive, pushy world of Big Pharma without comprehensive testing, testing that matches the drugs’ prescribed use and duration of treatment, is equally as dangerous — especially when drugs that might effectively treat the same condition already exist.

What has the FDA's response been? “The agency applies the same statutory approval standards of safety and efficacy to all drugs, but uses regulatory flexibility in applying those standards,” according to spokeswoman Sandy Walsh.