New data challenges whether the FDA is still the world’s toughest regulator

It’s quite puzzling why the Food and Drug Administration approved the new women’s libido-enhancing drug Addyi, a.k.a. “female Viagra,“ on Tuesday, when the drug has lackluster evidence of positive benefits and really troubling side effects. The FDA had already rejected it twice, and received no new efficacy data this time around. The only major thing that changed was a new marketing and advocacy campaign, backed by the drug’s maker, Sprout Pharmaceuticals.

Over at Forbes, the intrepid medical reporter Matthew Herper offers a data-driven explanation for why: The FDA basically approves everything these days.

Forbes commissioned a new analysis from BioMedTracker on the regulator’s drug approvals since 2008. The analysts found approvals have reached an all-time high, Herper writes:

As recently as 2008, companies filing applications to sell never-before-marketed drugs, which are referred to by the FDA as “new molecular entities,” faced rejection 66% of the time. Yet so far this year the FDA has rejected only three uses for new chemical entities, and approved 25, an approval rate of 89%.

When you look at the data in the way the FDA does (instead of using the BioMedTracker methodology) the approval rate is actually more like 96 percent. That’s close to 100 percent, which means the agency is pretty well accepting all the new drugs seeking its rubber stamp.
There are many explanations for this trend. Maybe drug companies — in this financially tight time — are only putting their very most promising products before the FDA. Similarly, Herper points out that the trend may be explained by the fact that the FDA has been “doing its job,” approving drugs in a timely manner and working more closely with drug companies before they file new applications to help make sure they meet regulatory requirements. This is a good thing, if better drugs are reaching patients.

But this doesn’t explain how the “female Viagra” got through after two rejections and pretty questionable efficacy data. So lobbying also matters, of course. As does politics, Herper notes: “To the extent that they think about the FDA, politicians on the right generally want the FDA to get drugs to patients faster, giving them choices. Those on the left worry more about approving dangerous drugs.”

Right now, the Senate is mulling a new bill, the 21st Century Cures Act, which, if passed, will speed up drug approvals and lower the bar for the evidence required to get medicines to market. Faster drug approvals aren’t necessarily a good thing, Herper warns:

In the late 1990s and early 2000s, there was a boom of new drug approvals. In 1999, the FDA approved two drugs that became synonymous with drug safety scandals: Vioxx, which was withdrawn from the market by Merck, and Avandia, made by GlaxoSmithKline, which later had its use severely restricted. The approval boom is good only so long as it doesn’t trigger another drug safety conference.

They also can’t solve the biggest problem here — the lack of promising treatments in the pipeline.

As Harvard’s Aaron Kesselheim told me recently, “When drugs are shown to be effective and safe, the FDA is the fastest regulatory agency in terms of approvals of new drugs in the world.” The hope is that the drugs racing to market are going to be, on balance, helpful to patients.

Read Herper’s worthwhile piece. And stand by for my feature on what’s changed at the FDA.