Meet One of the Most Important People in America Right Now: FDA Director of Generic Drug Policy, Maryll W. Toufanian

Maryll W. Toufanian is one of the smartest, most accomplished people we know. As the Director of the Office of Generic Drug Policy (OGDP) for the FDA (which includes the Division of Policy Development and the Division of Legal and Regulatory Support) she has her fingers on the pulse of pharmaceuticals and their development in the United States. We had the honor of sitting down with Maryll to discuss the state of the world and her experience at the FDA — exclusively on The Seam Podcast.

Amy: I am so excited to talk to Maryll Toufanian today. I have met some absolutely incredible women in my life. And I have had the distinct pleasure of meeting a few really incredible women through my husband over the last 20 plus years, and one of them is Maryll.

Maryll currently serves as the Director of FDA Office of Generic Drug Policy, which oversees the development and implementation of regulatory policy arising from all aspects of the generic drug program. Maryll is a recognized agency expert on matters concerning the Federal Law related to patents and other intellectual property, including protections for brand and generic drugs. She has masterfully represented the generic drug program in high profile meetings with industry and other national and international stakeholders involved in the ever changing regulatory landscape for generic drugs.

Maryll, a long time ago, you said to me that this was your dream job. Does that still hold true?

Maryll Toufanian: Yes. But, first of all, I have to thank you for that extraordinarily generous introduction. Hopefully, I will live up to the hype, at least a little bit. It is a privilege to do the work that I do. And this is actually a dream job for me, for the following reasons. I got into the law after a small stint in liberal arts graduate school and really loved the intellectual opportunities and engagement that legal thinking can present. And I had a really wonderful set of experiences before turning to FDA and joining the FDA, which allowed me to develop intellectual interest and expertise and work with really smart people. But there was always that something missing in terms of what good I was doing. And I think that getting up and going to work and making money and contributing to successful businesses and contributing to your family are all, in and of itself, dream jobs and dream opportunities.

But working for the FDA really was the opportunity for me to help people directly in a broad way. There's so much good work that the FDA does; it really is a program where you help people every day. I'm helping to make sure that the generic drugs that I take, that my kids take, that my beloved nephews take are safe and that they work just like the brand. And that they're available at a lower cost, which means more people can get them.

When my kinds ask me, "Why do you have to go to work?" I get to say, "I go to work, because I get to make sure that people's medicines are safe and they can afford them." And I couldn't think of a better reason to get up and go to work.

Amy: No, I cannot think of a better one. I just can't. And I don't think that most people even understand what the FDA does. What is the main role of the Federal Drug Administration?

Maryll Toufanian: Right. So the FDA has a website and I find it to be one of the more robust websites out there. It is actually designed to give people, real life folks, an understanding of what we do. And it's pretty easy to use. It's fda.gov and there are whole sections that are just for the patient, for the consumer, where you can recent announcements. If you come across a food label or a tobacco warning or something with your animal medications or food or the drugs and biologics, and the vaccines that you take, you can go to the website and ask, what's the story?

 But in general, I mean, the largest umbrella of the purpose of the FDA is to protect the public health, to ensure that the products that are used by the public — and I'm talking about food and drugs and medical devices, like pacemakers and all that stuff. It is our job to make sure that what is out there is safe and it works and it is what it says it is. If there's a drug company that wants to make a generic drug, they have to submit a whole portfolio of information to show that their drug is going to work just like the brand. And what we do is we say, "You're right, you've shown us it, you can be substituted by your pharmacist." or "No, you haven't done that."

 So the first, one of our most important roles is that gatekeeper.

 Another big job we have is to go after entities that are falsely representing that their drug or their product t as FDA approved. If it's not, we will sort of go after them in an enforcement action

 But the largest thing is we try to make sure that the drugs that we sanction do what they say they're going to do and safely.. And those we haven't approved or those that we've approved and sort of have gone off the rails stop that behavior.

“Wherever the political winds may be blowing, the dedication on the Hill in looking at our issues and making sure we have the authority to do the very best we can from a scientific perspective is something that I think makes the American system successful.”

Amy: How difficult is it, from start to finish, to get a drug or a vaccine or any medical device passed by the FDA?

Maryll Toufanian: Well, I would say in general, it's not so much a level of difficulty. As there's certain data and information that we need to give a thumbs up that the drug is safe or effective. And sometimes that might be easier to prove and sometimes that might be harder to prove. And what's really important to remember is the difficulty of getting something approved has to really start with the science. What is the science behind this drug? How are you going to show us from a scientific perspective this drugs going to say what you're going to do?

For a brand new drug that's never been used before, there's a number of really important steps and what's interesting, is in the current conversations under COVID, I hear reference to these steps and I have to sort of smile because this is something that I do every day. But for example, when you have a brand new drug, you have to figure out what the “stuff” is.

 Acetaminophen is the what's called the active ingredient in Tylenol. And so if you have a brand new active ingredient, you got to figure out what it is. And then you have to figure out what it might do. So there's a lot of what's called preclinical work where you sit in the laboratory and you analyze it and you think about its nature and what its chemical or biologic makeup is and what it might do. And then you have to look at, in that drug development stage, you have to think, "Well, could we make it? How do we make it? How do we put it in? What kind of product is it? Will it be most effective if it's in a pill and people swallow it or if it's injected, like an EpiPen into your body?"

There's a series of phases of studies that you do in humans to figure out is it safe to put in a human? That's usually what's described in phase one. Phase two, it's a slightly bigger group, where you start to suss out what actually you think you want to claim the drug can do. And then you've got phase three trials, where they're much bigger, where you're giving the drug to patients, and you're saying, "Take this drug, and you will see if it works or not." And that's where you hear that a lot of discourse today: "When are we going to get to phase three trials?" And that's that really like, "Is it going to do what it says it's going to do?" "Is it working better than a placebo."

 What FDA has tried to do recently, really in all of their medical product work is to make our requirements are more transparent.

Unfortunately, your question is a great one and it's sort of a complicated answer. But when people talk about developing drugs or new products that FDA will review or regulate and the costs, those costs are sunk into those development pathways that I just described.

Amy: And would you agree that the FDA is more stringent let's say than other equivalent bodies in other countries?

Maryll Toufanian: I don't want to comment on other countries because the efforts across the globe are just phenomenal. I mean, FDA likes to say, and I'll say it, that we're the gold standard; I think we really are. I think that the regulatory history that we have in this country and the experience and the work that FDA and the branded generic and all of the industries — and we've got real partners in Congress — all of the work we do is actually under the direction and requirements of the law that Congress will enact to let us do it.

So our standards for drug approval are actually set forth by Congress, and we've got a terrific resource in that. Whoever's in quote, unquote power, wherever the political winds may be blowing, the dedication on the Hill in looking at our issues and making sure we have the authority to do the very best we can from a scientific perspective is something that I think makes the American system successful.

Amy: In the 20 plus years that I've been deeply involved inn the women's cancer research side, I have found that scientific advancements and medical advancements has never wavered or changed based on political party. It's always been very consistent.

Maryll Toufanian: I would say that that has been my experience as well. Obviously, each administration, no matter what you hear, will have priorities: “We want to put our energies into this element of public health, FDA, etc.” But the good news is that we are highly scientific organization, and, in my experience, almost every part of it has been apolitical when it comes to the science. The science is the science.

Editor’s Note: This interview has been edited for length and clarity. To listen to the full version, please visit The Seam Podcast.