Senator Bernie Sanders and other Democrats recently introduced a bill to Congress that would allow commercial importation of drugs into the U.S. In response, four former commissioners of the Food and Drug Administration have penned an open letter, urging Congress to consider the risks of allowing drugs to be imported. The letter's authors included Dr. Margaret Hamberg, Dr. Andrew Von Eschenbach, Mark McClellan—current director of Duke’s Margolis Center for Health Policy—and Dr. Robert Califf—currently a faculty member at the Duke Clinical Research Institute. The Chronicle spoke with Califf, who served as commissioner from February 2016 to January 2017, about the letter and his views on the issue.
The Chronicle: Is the idea of allowing commercial importation of drugs relatively well-received and supported by the public? Why?
Robert Califf: I don’t know that it is well received by the public once they’re informed. On the surface, it’s easy. There’s no reason why the average person would be thinking about the entire system of the safety of drugs. It’s easy to fall into the trap of wanting to import all sorts of things. But the problem is with a pill, you can’t tell what’s in it. We already know a very high proportion of pills that come off the Internet are fake or adulterated or substandard. You can’t really tell with some medications by how you feel.
TC: A bill to allow commercial importation of drugs into the U.S. from Canada has been introduced by several Democrats. Is this a partisan issue?
RC: I can’t really tell. I think in general it’s complicated—there have been some Democrats in support of it. But the last several Democratic administrations have not supported it—the Obama administration definitely did not support it.
If you look at me, Mark [McClellan], [Hamberg and Von Eschenbach], four very different political constituencies put us in our jobs, and we all came to the same conclusion. But for the current version [of the bill], I don’t really know exactly where the support will lie. It’s difficult to tell how much of it is an effort is to force some action. The threat of such a bill might get people to take some other action that’s needed. Everyone agrees there’s a need to bring down drug prices.
I suspect [the bill] will probably have difficulty going through—as people dive deeper into bills, a lot of technical corrections are made to them. I hope as people look at it more in general, they’ll conclude this is not the right way of approaching the problem.
TC: What did you and the other former commissioners hope to accomplish with the open letter?
RC: I think the former FDA commissioners felt compelled to do this because it’s a safety issue for the American public. That’s really the call to action. Now, what should be done, we don’t all agree on—as you can tell from the letter. But I can tell you from my perspective we need to figure out a way to have direct negotiations [with drug companies]... when it comes to prices for innovative drugs. Companies can have a legal monopoly because of patents. That’s a good thing because it’s the only way to create enough value to get people to invest in development of the treatment, but there has to be a way to get negotiations directly with drug companies.
The other issue is that in the generic space—the overall cost of generic drugs has dropped 57 percent in the last five years, so it’s way down. But in these individual situations where people develop monopolies…. I personally think there needs to be specific legislation to close the loopholes and enable [access to the drug].
But when that does happen, one of the options the FDA has is to import that specific drug. Every once in awhile when there’s a crisis, then you secure a supply line, instead of creating an entire bureaucracy which would cost a lot of money to ensure safety. It’s not something I think any of us see Congress funding, despite what Bernie Sanders says. He said it would be all be funded. I think everybody saw the president’s budget—the likelihood that this will be funded is practically zero.
TC: American consumers do buy drugs on the Internet now. Do you think there needs to be some sort of regulation of that, since as you said, it can be dangerous?
RC: Well, there is regulation—it’s not technically legal to do it unless you have certain circumstances. Trying to intercept every package coming into the United States is an impossible situation. There’s an extensive multinational anti-criminal effort. [Drug importation] is one of the most lucrative forms of organized crime so there is a substantial effort in other countries to try to deal with this. But the idea that the U.S. government would pass a law that would make it even more overwhelming, just doesn’t make sense.
We will have a roundtable to flesh this out in a public way, because it’s out there and something needs to be done about people who entertain these high prices on particular drugs.