Former FDA Head Weighs In On Trump's Criticism Of Drug Approval Process

Trump has called the approval process "slow and burdensome" and said he wants to speed it up. NPR's Audie Cornish asks former FDA Commissioner Mark McClellan whether that's feasible.

AUDIE CORNISH, HOST:

One big focus of the Trump administration so far has been reducing government regulation. One area the president may try to do that - the Food and Drug Administration. In his address to Congress earlier this week, President Trump said the FDA's approval process is slow and burdensome, and he wants to speed things up.

To talk about what that might mean, I called up Dr. Mark McClellan. He was the head of the FDA under President George W. Bush. I started by asking about how long it takes now for the FDA to approve a drug.

MARK MCCLELLAN: The approval process itself is eight and a half months on average. And most drugs that finally make it to an FDA application do get approved, which is a sign of predictability in the regulatory process and also that it takes a lot less time than it used to. But that eight and a half months comes on the end of often years of development with lots of failed drugs along the way. And that's not the FDA fault. It's the fault of the challenges in developing and bringing to market safe and effective medical treatments. So the big challenge today is how do we make that process more predictable and less costly and work better for patients.

CORNISH: So what are the areas, then, that the FDA could speed up this process? And be specific. Are you talking about more staff? Or are you talking about changing standards?

MCCLELLAN: I think it's new kinds of staff that might be very good at some of the new statistical methods that can inform whether or not a drug is really effective and safe in actual use or not. It means finding markers for whether or not a drug works and is safe that don't require waiting a really long time. That was transformative, for example, in getting drugs for AIDS approved much faster by not waiting to see if patients actually died of complications of the infection, but showing that a marker for effectiveness of a drug was whether or not the drug got the virus out of the bloodstream. It's a much faster process for development and could really help bring down costs and development time.

CORNISH: Another issue people don't talk about very often is who pays for these drugs - in many cases, insurance companies. So they have a role here - right? - in terms of innovation and pricing.

MCCLELLAN: Yeah. With the rising cost of drugs and with the availability of a lot more drug treatments than have ever been the case before, insurers are playing a much more active role around who gets access to treatments, with many insurers deciding that there are existing less costly drugs available that work just as well and negotiating either lower prices or deciding in some cases not to cover some drugs at all, especially if there are still some unanswered questions.

CORNISH: So Donald Trump has talked about bringing down drug prices. And, you know, I feel like we should dig into this because you're also a doctor of economics (laughter).

MCCLELLAN: Sure.

CORNISH: Would reducing FDA regulations or speeding up the approval process save health care customers money?

MCCLELLAN: It can save health care customers money, but probably not in the way that people think. Many drugs are priced based on what the market is willing to pay for them. And one way in which faster drug approvals have brought down prices is when there is an existing drug that meets a medical need, but it's the only choice available. So we saw this happen with the cures for hepatitis C drugs. As soon as second and then a third similar drug made it to the market, the prices for those drugs all came down to the point where today it's about 50 percent of what the prices were, in many cases, compared to two years ago.

CORNISH: When you listen to the president speak about this issue, what questions do you have? Are you totally clear on what he's talking about?

MCCLELLAN: I think this is a general direction that the administration would like to go. I think it's going to take a little bit of time and building on some of the ideas that we've already discussed to sort out exactly how that will happen.

CORNISH: Dr. Mark McClellan - he's director of the Margolis Center for Health Policy at Duke University and FDA commissioner under President George W. Bush. Thank you for sharing your expertise.

MCCLELLAN: Audie, great to talk with you.

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