FDA defends its drug approval process after controversial reviews

Many experts have questioned the FDA's drug approval standards over the past few years, as several controversial drugs have gotten the green light despite less rigorous testing.

What they're saying: Peter Stein, the head of the FDA's office that analyzes new drugs, sat down with Zachary Brennan of Regulatory Affairs Professionals Society and said the only thing that's changed with the FDA's approval process is a shift in the types of drugs the agency is reviewing.

• "If you look in the last couple years, we still see some drugs for chronic diseases, but even there, it tends to be subgroups and populations that were undertreated with drugs previously available, and what we're seeing is a dramatic increase in drugs for rare diseases," he said.

The bottom line: There's no doubt biotech startups and drug companies have invested more time and money in treatments that go after cancers or conditions that treat a very small subset of people. Those kinds of medicines usually command the highest prices.

• And the FDA is saying those types of drugs have more leeway in the approval process, even if they only have one trial or don’t have randomized test groups, because "patients and physicians are willing to accept a bit more uncertainty."

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