A Conversation With Outgoing FDA Chief Scott Gottlieb

There have been a number of reports recently about tainted ingredients in medicines, particularly those manufactured in China. What advice do you have for the average consumer about why they should be confident that the medicines that they’re taking are safe?

Well, I think that they should be confident that the medicines that we’re taking are safe. We vigorously inspect overseas manufacturing facilities. We sampled about 350 drugs in the market to look at generic drugs in particular. We’re talking about generic drugs mostly here because those are the ones that are manufactured by and large outside the U.S. And we found no discrepancies between the generic drug and the branded equivalent in terms of purity, potency, the level of active pharmaceutical ingredients. 

That said, the world is getting much more complex. Much more of the active pharmaceutical ingredients are manufactured overseas. A facility overseas is harder to inspect. It’s harder to get resources over there, although we do it. 

When it comes to dietary supplements, do you think the FDA needs more authority to regulate them and provide more public education?

We think it would be helpful to have mandatory ingredient listing so you have disclosure of what is in dietary supplements. That’s something that could make it more efficient to get new products on the market, but also allow us to provide more oversight when new products and new ingredients come onto the market.

We think having mandatory recall authority, the ability to recall products, could help us take action more quickly. We certainly think that the industry has grown very big and created more potential opportunity, but also, more potential risk.

I want to talk about off-label medicines. Are brand-name drug companies skirting safety when they sell a drug for something other than what it was approved for, basically eliminating the need for new scrutiny? Are they allowed to urge doctors to prescribe a drug for something that it wasn’t approved to treat?

Legally, they can’t urge doctors to prescribe them for unapproved uses. That would constitute off-label marketing. They can get in trouble with the law. That doesn’t mean that they don’t do it. I think that there is less and less of that behavior going on in the market. That doesn’t mean that it doesn’t still go on. We send warning letters on it, but I think that there has been so much scrutiny that you see less of it. 

What can the average consumer do to ensure that the drug their doctor is prescribing for their illness has been approved for that purpose?

I think consumers should always ask their doctors for the information for the particular use of the drug. It’s a very straightforward question to ask: Is the drug approved for that use?  

When it comes to food safety, we constantly hear about food being contaminated — from romaine lettuce to chicken to baking flour. Should people be more concerned than ever about the safety of their food? What should the average person out there do?

I think that the food is safer than it has ever been. The food supply chain has also gotten more complex, like the drug supply chain, but we are able to identify many more foodborne outbreaks than we’ve ever been able to because what we’re able to do now is use genomic tools to correlate outbreaks of human illness together. 

Ten years ago, there might have been 30 people in New Jersey who got a stomach virus, but you would have never known that those 30 people had the exact same pathogen. Now when you have 30 people in New Jersey all infected by the same strain of E. coli, the exact same strain and maybe a strain of E. coli in the database that we maintain has been associated with foodborne outbreaks before, now you know that it was something they ate. Now you’re able to talk to them and find out what they ate, what is the common source, and then go to the common source and do soil testing and other sampling to see if we can find that strain in whatever facility produced the food.

To give you a real-life example of this, we did a major recall of eggs one year ago this month. It was a North Carolina facility. We recalled tens of millions of eggs. It was a huge recall. What had happened was there was an outbreak where people were sporadically getting sick. When we interviewed the people, we found out that they had all eaten eggs in the same restaurant chain. The entire chain sourced their eggs from one facility. We went into that facility and took samples and found the exact same pathogen in one henhouse and in the production line. 

You’ve focused on the availability of biosimilars during your time as commissioner. [Biosimilars are the generic versions of biologic drugs, made from living organisms, and are priced lower than brand-name biologics.] The Affordable Care Act provided a path for approving biosimilars, but that market hasn’t taken off as much here as it has overseas. Why are biosimilars so important, particularly in the debate over lowering prescription drug prices?

I think they’re important because biologics is the fastest-growing segment of drug spending. These are generally used in patients with more serious medical conditions and they can be out of pocket a lot of money for these drugs even if they have good coverage. If a drug costs $100,000 and the patient has a 10 percent copay, they quickly maximize their entire out-of-pocket for the year. It’s a public health concern if patients can’t have access to these medicines because they can’t afford them. 

What has to happen for biosimilars to become more popular?

Health plans are meeting a lot of resistance from physicians who don’t feel comfortable [prescribing biosimilars instead of brand-name biologics]. That’s the biggest challenge right now, but I think that that challenge will start to resolve over time as doctors gain more comfort with these. We need to educate physicians. It’s going to be a slower process, but I don’t think it’s an insurmountable hurdle. It’s going to happen.  The same thing happened when we created the pathway for traditional generic drugs; doctors were reluctant to use them. There was a lot of skepticism that they weren’t the same thing. It took time to build comfort.

You’ve called out many of the biggest prescription drug manufacturers for thwarting the development of generics. You referred to their tactics as “shenanigans.” What needs to happen to increase access to generics?

We make a tradeoff in society where we allow innovations to be priced high in order to provide returns on the risk-taking and the investment, with the expectation that there will be competition down the road. 

Companies were using the risk management programs that we have promulgated as a way to thwart the ability of generic companies to get access to the doses they need in order to do the studies that they needed to run to get market approval for a generic. They’re still doing that, but they’re doing it less now. 

What I see them doing more of is using specialty pharmacy companies to tightly control who they sell the drug to. They might distribute the drug through a single specialty pharmacy and have agreements with that specialty pharmacy that say, “You can’t sell to anyone but these entities.” They exclude the generic company from being able to buy the drug. 

So they’re moving on to different tactics in the marketplace. That doesn’t mean that we should forget the old problems, because as soon as we take our eyes off of them, that behavior might crop up again. It does mean that we need to make sure that we are also focused on the new gaming tactics.