I think that there are answers that are more medium-term to prevent this problem from happening again. By 2022, Congress will have to reauthorize what are called the ‘drug user fees.’ Basically, the FDA’s approval system for generic and brand drugs is largely funded by user fees that the companies pay when they submit applications. And during that process of reauthorization, there are usually substantive provisions in the legislation that deal with important issues. So, I think in the medium-term, you’re going to see the FDA wanting to focus on incentivizing new manufacturing technologies. I think you’re going to see a focus on the FDA wanting to expand its inspection capacity, increasing its ability to approve drugs more quickly. These issues are going to be coming up in the legislative cycle that will end in a reauthorization law in 2022.
Heilbrunn: And all of this applies to a potential vaccine for the coronavirus, right?
Sklamberg: That’s a bit different. The vaccine is currently in development, and the FDA and the industry that is working on it have a well-developed system to cut red tape and accelerate the production of vaccines. The issue with vaccines though, is that you have to do the clinical trials yet to make sure they work. Dr. Anthony Fauci (from the National Institute of Allergy and Infectious Diseases) has talked about a time frame of a bit over a year, and that is an accelerated time frame for the development of a vaccine—because obviously if it doesn’t work, it’s of no use.
Heilbrunn: And beyond it not working, it could actually have deleterious effects?
Sklamberg: There are two issues, obviously. The vaccine has to work and it has to be safe. And you have to make sure that it is both safe and effective before you’re going to be using the vaccine on a large scale. And there are very well-established channels for conducting those clinical trials, and for making those evaluations, and for moving as quickly as possible. But you have to have the clinical trials, you have to have the patients, and then you can approve the drug, and move to have large-scale production.
Heilbrunn: So your bottom line is that if the coronavirus pandemic continues to be a significant force, that will create problems but not a crisis for the drug supply?
Sklamberg: It’s hard to predict whether it will be just problems or a crisis, because it really does depend on where production is shut down, and of which drugs and how essential they are. I will say that it is a great challenge for the system and that has the potential to be harmful to people who rely on specific drugs, but it’s really hard to predict the extent of it.
Jacob Heilbrunn is editor of the National Interest.
Howard Sklamberg, former deputy commissioner for global operations at the FDA, is a partner at Aiken Gump Strauss Hauer and Feld LLP. Image: Reuters