Working at the Food and Drug Administration

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0:00:14.26 I'm Janet Woodcock, and right now I'm director of
0:00:18.20 the Center for Drug Evaluation and Research at the FDA.
0:00:22.13 And I'd like to tell you a little bit about my story
0:00:25.15 and how I came into this position, and what kind of work I do.
0:00:30.20 I'm a physician... a rheumatologist,
0:00:33.11 and I went to medical school thinking I would go into medical practice.
0:00:37.26 But, fate had it that, because of my research interests
0:00:43.17 in monoclonal antibodies, I ended up working at the FDA as a part-time reviewer,
0:00:49.20 right when the biotech revolution was beginning.
0:00:53.22 And so, I saw at that time what the FDA actually did,
0:00:59.00 which is kind of an intersection between law, medicine, science, and policy.
0:01:06.09 And I was so fascinated by it that I spent the whole rest of my career here.
0:01:11.28 So, to kind of go back... How was I trained, and how did I get to that point?
0:01:18.04 Well, I went to college hoping to become a biochemist,
0:01:21.17 and so I majored in biology and chemistry
0:01:24.10 because they didn't have a biochemistry major in that time.
0:01:27.23 And when I graduated college, I went and worked as an analytical chemist for a few years
0:01:32.22 because I was kind of tired of being educated.
0:01:35.11 After that, I was tired of being an analytical chemist,
0:01:40.21 and I went to medical school and learned to become a doctor,
0:01:45.26 and went through and did internal medicine and then rheumatology at UCSF,
0:01:52.18 which I thoroughly enjoyed.
0:01:55.18 And, all that training I think -- both my training in the basic biology and chemistry
0:02:02.25 and the basic sciences, as well as my training in analytical science
0:02:07.20 and my medical training and sub-specialty training --
0:02:11.07 has all held me in very good stead in the work that I do at the FDA.
0:02:16.19 So, I thought I might give you some idea of the spectrum of the kind of work that the FDA does
0:02:24.08 and my role in it now.
0:02:26.28 The Center for Drugs, where I work,
0:02:29.18 regulates all the drugs in this country --
0:02:32.24 the over the counter drugs, all the generic drugs, the prescription drugs,
0:02:38.24 and the new drugs that come on the market, as well as many drugs
0:02:42.16 that are illegally marketed in the United States, which we try to remove from the market.
0:02:48.15 The only group that also works in this space is the Drug Enforcement Agency,
0:02:53.04 and they take illegal narcotics and stuff and take those off the market,
0:02:57.06 but most of the rest of the unapproved drugs the FDA has to deal with.
0:03:02.01 So, we have a very broad spectrum of work.
0:03:06.00 What most people know us for is the new drug review program.
0:03:10.09 In that program, the FDA gets involved in drug development
0:03:14.21 at the time that an investigational drug,
0:03:19.11 a drug candidate... in other words, a molecule that's gone through pre-clinical development
0:03:24.28 and is thought that it might be a new therapy
0:03:28.03 first gets into people.
0:03:30.06 At that time, something called an investigational new drug application or IND is needed.
0:03:36.04 And whoever the clinician or scientist that's running that Phase I trial
0:03:42.16 is, they have to send an IND to the FDA to get approval for doing the study,
0:03:49.06 and they also have to get approval from an IRB and other parts of their institution.
0:03:53.06 And those studies are backed up by a lot of toxicology and chemistry
0:03:58.29 and other information to make sure that molecule, whether it's a biologic
0:04:04.25 or a small molecule, or whatever it is
0:04:06.22 is safe enough to be tested in people.
0:04:09.13 As a result of all of this work and FDA oversight and so forth,
0:04:14.09 Phase I trials in this country are very safe.
0:04:17.11 And the people who participate in them are well protected.
0:04:20.24 And it's a big job, reviewing all these new applications
0:04:25.03 and overseeing the safety of the Phase I trials.
0:04:29.00 But the FDA is also in charge of all of the drug development that occurs
0:04:33.08 during the investigational stage.
0:04:35.04 Because, if the drug proves safe enough in the Phase I trial,
0:04:39.14 then it goes into broader trials and more people to determine the correct dose,
0:04:44.00 what the side effects are, does it work, and finally into large efficacy trials,
0:04:48.29 where whether the drug is effective in a large population is determined.
0:04:55.22 And the FDA has to oversee all of that, as well as set the standard
0:04:59.15 for how the drug is manufactured and what is the meaning of efficacy
0:05:05.20 or effectiveness of the drug,
0:05:07.24 as well as how much risk can be tolerated -- how many side effects can be tolerated for that drug.
0:05:14.07 And after all that investigation is done, which generally the whole drug development program
0:05:21.04 for a single successful drug costs about a billion dollars,
0:05:24.25 an application will be sent to the FDA for marketing of the drug,
0:05:30.13 and at that point the FDA will review all of that information on manufacturing and toxicology
0:05:37.12 and safety and effectiveness and the drug label, and all of this information,
0:05:43.12 and finally render a judgment on whether the drug can actually be marketed in the United States.
0:05:48.06 So that's the new drug review process.
0:05:51.04 Subsequently, the drug may be studied for other indications,
0:05:56.15 so there's more investigational work that goes on.
0:05:59.11 And the drug may be developed in other formulations,
0:06:02.26 maybe intravenous versus a pill versus intramuscular, and so forth,
0:06:08.04 and all of those things may be done after the drug is initially marketed.
0:06:12.23 After all the patents and exclusivity have run out on a drug
0:06:16.19 then the generic industry can make copies.
0:06:19.18 And currently, in this country, about 80% of all drugs that are dispensed to patients
0:06:25.02 are generics. The generic drugs have saved consumers billions of dollars over
0:06:30.07 their time, and we approve many hundreds of generic drugs every year.
0:06:35.21 But we have to make sure every generic drug we approve will have equal performance
0:06:41.21 to the drug that it's replacing.
0:06:43.16 And so that's a very heavy burden, and we have to review all the chemistry
0:06:47.18 and the manufacturing to make sure that formulation will perform the same,
0:06:51.28 and then we have to make sure the drug is bioequivalent.
0:06:54.28 In other words, it's absorbed into the body at the same rate and extent as the innovator drug is.
0:07:00.06 And, because the appearance of a generic suddenly lowers the price very dramatically
0:07:06.20 of any drug on the market, there's a lot of litigation and lawsuits
0:07:11.00 that go on around the generic drug program.
0:07:14.04 And in my current job, I'm involved in dealing with all these lawsuits and litigation,
0:07:18.24 and that's just part of the commercial process.
0:07:22.06 So, the generic drugs get on the market, too.
0:07:24.25 Now, for all the drugs on the market, which we call the therapeutic armamentarium,
0:07:30.03 the FDA is responsible for watching those
0:07:33.04 and making sure that they don't have any unexpected side effects
0:07:37.03 that are serious or not on the label
0:07:39.16 that people don't know about.
0:07:40.27 And so, we have multiple ways of doing that. We get about 800,000 reports every year
0:07:48.01 that we have to look at from doctors and drug companies and other health professionals.
0:07:55.15 About 400,000 of those are both serious and unexpected.
0:08:00.12 And that means they're not on the drug label because they're unexpected --
0:08:03.25 we didn't think they were associated with the drug, but they're also serious.
0:08:06.29 And so, all those 400,000 reports, we really have to follow up on
0:08:11.05 and make sure is that a real association? Did the drug really cause that?
0:08:15.02 Does it alter the benefit-risk ratio, so that maybe the drug should come off the market?
0:08:19.22 Or not be used anymore?
0:08:21.17 Or is it something that simply should go in the drug label?
0:08:24.08 And so we have a huge drug safety program that is involved in monitoring
0:08:28.26 all that and trying to figure this all out.
0:08:31.04 We also have something new called the sentinel system.
0:08:35.19 And that's taking advantage of electronic health records in the United States.
0:08:39.24 And the sentinel system now has 125 million lives or people's health records,
0:08:46.20 mainly claims data, in the system.
0:08:50.15 And we can query that... look for a drug and maybe a side effect and see if,
0:08:55.17 in the sentinel system, if some increase in the side effect has been observed.
0:09:00.10 Now, another part of our program is our compliance program.
0:09:05.12 We have to go out and check and make sure everybody's obeying the rules.
0:09:09.10 We check on how they manufacture drugs to make sure they manufacture them properly.
0:09:14.09 It's very surprising, probably, that many times, things go wrong.
0:09:19.02 There are mix-ups, the wrong pills get in the bottle,
0:09:21.27 particles or bacteria get in injectables, and so they can harm people.
0:09:28.00 And so, the FDA has to watch to make sure that is not occurring.
0:09:32.16 And with globalization, where factories have moved all over the world,
0:09:38.00 particularly India and China, Brazil, and a few other places,
0:09:41.24 our job has increased in its intensity and difficulty.
0:09:46.19 And so, we really have some difficulty getting to all these places
0:09:51.14 and making sure the quality remains high.
0:09:54.15 Now, many of you are scientists in training or scientists,
0:09:59.01 and you might be interested in what is the role of science here.
0:10:02.00 Science has a tremendous role in drug regulation.
0:10:07.05 We have laboratories that do analytical science as well as basic science,
0:10:13.16 such as immunology and other disciplines that are relevant to drug therapy.
0:10:19.17 We have a whole clinical pharmacology unit, and we probably have
0:10:24.20 the best modeling and simulation group in the world.
0:10:27.21 So, they're highly mathematical individuals. They use a lot of computer time
0:10:31.25 to model clinical data and pharmacokinetic data and so forth,
0:10:37.07 and they add a tremendous amount of value.
0:10:39.18 We probably also have the largest group of biostatisticians, I think
0:10:43.14 in one place, at FDA in the Center for Drugs.
0:10:47.27 Many of them are PhD level biostatisticians,
0:10:52.14 and they both review the clinical trial results and do statistical analysis on safety data
0:10:58.23 and many other aspects of our scientific work.
0:11:02.00 And they're very big contributors.
0:11:04.28 We have a lot of medical doctors. I think we have about 250 clinical doctors.
0:11:10.16 Most of them are involved in the new drug review process,
0:11:14.00 making sure that those new drugs are safe and effective and looking at the medical evidence.
0:11:20.07 But they're, of course, clinicians within the safety office, as well as pharmacoepidemiologists --
0:11:26.13 people who look at human risk factors, failure mode analysis, and so forth,
0:11:35.01 because there are a lot of problems drugs get into:
0:11:37.24 people use them wrong and the label confuses them, and so forth.
0:11:42.06 There's name confusion and the pharmacist or the doctor's bad handwriting
0:11:47.16 causes the wrong drug to be substituted. Sometimes this can be a fatal event.
0:11:52.25 And so, we work very hard to make sure that drug names are...
0:11:57.00 don't get confused with one another, and that's another discipline
0:12:00.08 we have is a whole risk-management, failure mode analysis,
0:12:04.05 human factors analysis, and so forth discipline.
0:12:07.16 We also have social scientists. They're involved in some of the end points
0:12:12.17 for drug review. For example, patient-reported outcomes. How does it feel to the patient?
0:12:18.03 What's the impact on the patient?
0:12:20.01 We need social scientists to make those surveys,
0:12:24.26 or vet those patient-reported outcome instruments,
0:12:28.06 and make sure they're valid and giving us the right results.
0:12:31.25 We also have social scientists within the communications shop
0:12:37.14 because, probably, I think one of the most difficult things humans can do
0:12:42.12 is try to communicate risk to people
0:12:44.16 and have them understand risk, and we try to put that risk in context for patients.
0:12:50.24 So, I hope I've showed you that there's a tremendous variety of work:
0:12:56.06 scientific work, legal, and policy work that goes on in the center.
0:12:59.29 Despite all this elaborate apparatus and all the things that go on,
0:13:04.02 and despite all the tremendous promise in biotech
0:13:07.24 and new discoveries at the basic science level,
0:13:10.26 the drug development enterprise, which is really the engine
0:13:14.09 that translates all these new discoveries into human health benefits...
0:13:19.17 that engine is in trouble.
0:13:21.10 There's a crisis in the pharmaceutical industry,
0:13:25.06 and they're having to lay off staff, cut back their research and development activities,
0:13:30.23 and really focus on getting specific products out the door.
0:13:36.26 The biotech industry is struggling right now, as well.
0:13:40.18 And investors are removing their capital from the enterprise and putting it elsewhere.
0:13:45.09 And so, there's great concern that the enterprise may not survive in its current state
0:13:53.22 and all these wonderful discoveries that probably many of you are involved in
0:13:57.13 will not make it into helping patients.
0:14:00.12 So, one of the things I've been involved in here and working with others here at UCSF
0:14:04.17 and elsewhere is to figure out how we can modify or change
0:14:09.05 the drug development enterprise
0:14:12.05 to make it viable and make sure that it maintains over time
0:14:16.14 and that all this wonderful knowledge actually bears fruit in terms of human health.
0:14:22.26 So, our plate is full, but people who like varied work in
0:14:28.07 reviewing data and bridging between the science and clinical and law
0:14:34.19 would find a career at the FDA to be a very rewarding experience
0:14:38.27 and I can honestly say I've enjoyed almost every minute of it.

This Talk

Speaker: Janet Woodcock

Audience:

Educators of H. School / Intro Undergrad
Student
Educators of Adv. Undergrad / Grad
Researcher
Educators

Recorded: September 2012

Talk Overview

Involvement with the Food and Drug Administration (FDA) early in her career convinced Woodcock to change her plan to be a clinician and instead, to join the FDA full time. In this talk, she describes the responsibilities of the FDA and the important role of science in converting discoveries into new drugs for human health.

Speaker Bio

Janet Woodcock

Dr. Woodcock joined the FDA in 1986. She has held various positions including overseeing the approval of the first biotechnology based treatments for multiple sclerosis and cystic fibrosis. Currently, she is the director of the Center for Drug Evaluation and Research which ensures that drugs in the USA are safe and effective. Continue Reading