She proved you can reform a large agency stuck in its ways

Lots of promising and low-cost drugs get down people's gullets thanks to decades of reform at the Food and Drug Administration (FDA).

Lots of promising and low-cost drugs get down people’s gullets thanks to decades of reform at the Food and Drug Administration (FDA). She’s retired now, but the Federal Drive with Tom Temin next guest was the agent behind the modernization of the FDA’s drug-review process. Colleagues call her a force of nature. Now she’s a finalist in this year’s Service to America Medals Program: Former principal deputy commissioner Janet Woodcock.

Interview Transcript: 

Tom Temin
I guess people forget that 30 years or so ago, FDA was really a cumbersome apparatus, keeping things from getting to the public that should have. Fair way to characterize it?

Janet Woodcock
Sure. People talked about the drug lag that people in other countries all over Europe and other places, were able to get drugs, newly introduced drugs for previously untreated conditions. Much faster, years faster, than they could in the United States.

Tom Temin
And what inspired you to try to start changing this?

Janet Woodcock
Well, I’m a doctor. And my focus has always been on patients and helping people and relieving suffering. And when I took over the Center for Drugs in 1994, the user fee program had just started. And part of the reason FDA was so slow was that it was so under resourced. And the user fee program was to address that. But it was also not managed. And so we had to put in and really developed the procedures to make sure that drugs are thoroughly vetted, that they’re safe, that they’re effective. But that we can get through that waiver process. We can get through the information quickly.

Tom Temin
And I understand one of your big reforms was convincing Congress to let the agency initiate user fees for generic manufacturers, because that was taking a long time. This was the practice for the primary inventors of the drugs, they had to pay for the processes, but not the generics.

Janet Woodcock
Yes. And that was a tough battle. The generic industry wasn’t well United about it. But we finally got it through. And that year, we approved 1,000 generic drugs. And those are so important, because those are the drugs that you can get like for $10 a month, you can get your drug supply of generic drugs. And it really lowers the cost, but there has to be more than one generic kind on the market to really get the prices down. So we got that through. And we totally overhauled our process new computer system, total reorganization of the process and so forth. And the success has continued. And the industry has been satisfied enough that they’ve agreed of Congress, reauthorize the program.

Tom Temin
And you mentioned computer systems and the FDA was noted for being a little bit behind at some point in the technology base that it had to enable employees to get their work done. Tell us about what you did there. What you helped do there?

Janet Woodcock
Well the problem was people would deliver tractor trailers full of dossiers to our loading dock. And then the people reviewing them, some of them were still dictating and then having secretaries type with carbon paper. I got everyone to move over to electronic, electronic submissions, electronic review, electronic signatures and so forth. This means we can access the data really fast. They can see what they’ve done in the past too, because it’s not in some document room miles long paper. But that was a big struggle and big effort, involved many people, but we got it done. And really we’re paperless now and they have been for quite some time.

Tom Temin
We’re speaking with Dr. Janet Woodcock. She retired as Principal Deputy Commissioner of the FDA. And she’s a finalist in this year’s Service to America Medals program. And you are a doctor, what got you interested in federal service and particularly the FDA in the first place?

Janet Woodcock
It was kind of an accident. I was working at UCSF in San Francisco, my husband transferred to NIH shot from Stanford. And so I came along with a small baby. And so I didn’t want to pick up a really academic type of job. So I started working part time at the biologics Center at FDA, because I had been doing research on monoclonal antibodies, and they were regulating them at the time.

Tom Temin
Right. And so that you decided you liked it enough that part time became full time.

Janet Woodcock
It was so interesting. It was a combination of medicine, science, law, policy, all mixed together. And that was in the throes of the biotech revolution. In the program I ran, we approved like the first drug for cystic fibrosis. We approved to drug for multiple sclerosis, that was really became the standard of care for quite a long time, although that was a fight to get it through. That was about the first time I learned about some of the agencies, shall we say challenges and opportunities for improvement? Why some the fight we had over getting that approved for multiple sclerosis. But when I retired, I got a letter from a woman. And this was approved 30, 40 years ago. 30 years ago, from a woman in the Midwest, she said she got in the lottery when that drug was approved, and was able to get it because there was a shortage. And it changed her life. And she’s been healthy ever since, her multiple sclerosis under control. And I’ve heard from a lot of patients on the outside people who have been helped by the medicines.

Tom Temin
Another quality that you brought was a better relationship between the agency and the drug industry. Because when there’s too much contention, things can really slow down. How did you approach that one?

Janet Woodcock
Well, many people seem to believe that adversarial relationships are good, and they feel good about them. But I really stress professionalism. Our job isn’t to fight with people, our job is to be impartial about scientific evaluators. And on behalf of the public, on behalf of the patients, and it doesn’t help patients if you’re fighting with a company, they do the wrong development program. They have a promising drug. But when they come in, you say all sorry, you have to start over again, who does that really help? It might make somebody feel good, that they were so strong and so forth. But actually, it isn’t the right way. The FDA needs to work with the companies figure out how the drug should be evaluated to see what its performance characteristics are and if they meet the standards. And that means interacting. Because often this is uncertainty, we’re talking in a lot of cases, the best cases, we’re talking about drugs that are treating conditions don’t have treatments now. And so nobody really knows how to evaluate them. And so there has to be that collaboration. But that doesn’t mean what they call regulatory capture. That simply means a high level of professionalism.

Tom Temin
And I guess maybe even regulators need a certain degree of humility. And I don’t know deference so much, but a sense of restraint sometimes in how they approach those that are regulated. Because they’re trying to be productive also.

Janet Woodcock
Well, you have to realize I think, and that was something that was always challenging when I was at the agency. The agency is always severely criticized for anything. It’s seen as quote a mistake. Ok. So if a drug gets out there, and then there are unforeseen problems, and everybody, whatever hearings, what have you. And on the other hand, all the triumphs are really not recognized very much, particularly as medicines may cost a lot. So, the reviewers are under a lot of pressure to get it right. And that can cause excessive conservatism. And people have to realize we’re working not for ourselves, we’re working for the people of this country on their behalf. And that means trying to get it right, and not pushing for absolute perfection, because that doesn’t happen in human endeavors.

Tom Temin
And finally, you served a lot of commissioners. And without naming names, what makes an effective commissioner over such a sprawl? It’s a sprawling empire in many ways, and has many, many different domains, because it is food and drugs. And there’s a huge infrastructure that supports it. What should the commissioners do to be most effective?

Janet Woodcock
I think they need to pick their battles. We’ve had effective commissioners who have been in the political media sphere. They’ve been the face of the agency very effectively. They’ve been very good at that. We’ve had commissioners who are very good at administration, and try to figure out certain things that they want to accomplish administratively, when they’re in the position. People who struggle kind of don’t, they’re trying to do everything. I think, as you said, the agency is so large people on the outside have a wrong idea of what the role of what a Commissioner can actually do. He’s acting commissioner for a year at the agency and during COVID.

Tom Temin
Lucky you.

Janet Woodcock
Well, I think I could bring a lot to that role because of my long experience in the agency. Our biggest crisis we had then was infant formula, which wasn’t a drug issue at all. But I think people really need to trust the career staff and they need a commissioner to be very successful, will lean on the career staff and not come in. I think everybody’s a bunch of idiots. And they have to take over and so forth.

Tom Temin
This is really the final question. What makes a great retirement for someone that has accomplished so much, and then in the spotlight so much?

Janet Woodcock
I’m enjoying it greatly. I still have, I’m not going to be doing consulting or anything like that type of thing for specific products. I think what makes a great retirement is having a lot of interest that finally you can really exploit once you’re done with the heavy level of responsibility. It’s really liberating.

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