The abortion pill lawsuit that could change how the FDA approves drugs
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A Texas lawsuit attempting to ban pills used in medical abortions could have an impact on how the FDA approves medicines as a whole.
“To the extent that all of these things become a political question or a judicial question rather than a question of science and medicine, we’re in a very dangerous place,” physician Amanda Banks says.
The uncertainty could throw the pharmaceutical market into chaos.
“For the industry, the results could be catastrophic. For patients, it stands to be even more so,” Banks adds.
Today, On Point: How the attempt to ban the drug used in medical abortion could impact much more than just one pill.
Glenn Cohen, professor at Harvard Law School. His research focuses on bioethics and health law. He co-wrote an amicus brief along with 18 other food and drug law scholars in support of the FDA in this Texas lawsuit. (@CohenProf)
Eva Temkin, partner at the law firm King & Spalding where she counsels clients on issues related to the FDA from drug development to post-market regulation. She worked at the FDA for over 8 years, before leaving in 2021.
Amanda Banks, physician and adviser to multiple biotech companies and other organizations within the industry.
Robin Feldman, a professor at UC Law in San Francisco. (@ProfRobnFeldman)
MEGHNA CHAKRABARTI: We’re talking about what could potentially change regarding the FDA’s ability to approve and regulate pharmaceuticals in this company based on what is happening right now in a Texas court over the pill used for medical abortion. Now, this is a case that’s being watched by many, many people. And not just folks on either side of the abortion debate in this country. It’s being watched by the entire pharmaceutical industry, as well.
So we spoke to Amanda Banks. She’s worked in biotech and medicine for almost 30 years. She co-founded a biotech company and has advised multiple others and taken part in many clinical trials as a physician. And she says she knows what it takes to get a new drug approved by FDA. She says it’s a long and thorough process, but one that is very predictable.
AMANDA BANKS: For people who are in companies who are developing new therapeutics, diagnostic products and new vaccines to understand the process, the regulatory process, so that when they undertake their development plans, they can account for all of the things that the FDA is going to need and require, in order to convince the FDA that there is sufficient safety and efficacy associated with their products. And so it’s a very well known, no surprises kind of thing. And it offers an opportunity for stability in what’s an incredibly and increasingly high-risk endeavor of developing new medicines to treat patients’ illnesses.
CHAKRABARTI: And Banks says the uncertainty surrounding this case could potentially scare off investors who would put money into developing new drugs, billions of dollars into the industry potentially.
BANKS: If they have the option to put their money into something that is already risky but has become not only more risky, but less predictable. We’re going to have a very hard time raising the kind of capital that’s required to keep this industry moving forward. And I think for the industry, the results could be catastrophic. For patients, it stands to be even more so.
CHAKRABARTI: And Banks says because lack of investment could stifle innovation.
BANKS: And this is where it gets much riskier, right? Because you’re doing, by definition, something new that’s never been done before, and you only have a little bit of validation of the science because it’s very early. So you need investors that can take a long view and have a high tolerance for risk. But it’s a risk that they understand. If you now throw in an unknown risk, which is despite several decades worth of data to prove the safety and efficacy of a medicine, it can still be pulled off the market. If one person disagrees, then that is a different situation and it’s a very hard risk to manage.
CHAKRABARTI: So she’s talking there about the potential politicization of almost all drugs in this country. And Banks told us that she thinks drug approval should be a question of science and medicine, not political or judicial. So she wants Congress to make sure that is very clear.
BANKS: I hope that one consequence of all of this is that we get some legislative barriers around the FDA that shore up what is already sort of statutorily laid out as their mandate. And, frankly, protecting the right of a company that has received an approval from the FDA to sell a medicine, to continue to do so.
CHAKRABARTI: So that’s physician Amanda Banks. Now, as we’ve heard over the course of this conversation, the drug approval process at FDA is thoughtful, it’s thorough, it takes a long time. And Eva, I’m going to turn to you on this. Because feel free to correct me if I’m wrong, but a lot of the data that FDA relies on in order to come to its approval decisions have to come from the drug makers themselves. Right? Because they’re the ones doing the trials.
And FDA doesn’t always get it right. I mean, I was just reading just this week about a drug called Makena. That’s that was made by AMAG Pharmaceuticals. It was the only drug FDA had ever approved to reduce potentially reduce preterm births in this country. But from what I understand, the approval for this drug was based on just one study that was published in 2003.
And some physicians had some really serious concerns about it right out of the gate because there were flaws with that trial. And it was only last fall that FDA decided to backtrack. So 20 years later, roughly, and withdraw its approval for the drug. So is the process really as universally rigorous as we’ve been making it out to be?
EVA TEMKIN: I mean, it’s a hard question because I can’t promise you that 100% of the time anything will be right. And the Makena withdrawal proceeding has been going on for a very long time is an example of FDA sort of grappling with maybe having gotten something wrong. But I would say that the mifepristone approval and that drug share very little in common. Right. The process that mifepristone went through took years.
There was enormous amounts of data to support the approval. And there was an enormous amount of data that has been generated since then that continues to support safe use. And more than anything, I think the point which Dr. Banks made very eloquently is that FDA needs to be the arbiter of this decision. So whether FDA wants to change its mind based on new data, or based on a reimagining of existing data is a different question, I think, from whether a person who disagrees with FDA’s decision about safety and efficacy can and should bring a judge to second guess that scientific decision making.
CHAKRABARTI: You know, but unfortunately, as we all know, politics has been injected into the FDA. It’s kind of a bipartisan effort in years past, even though we want it, ideally, to be a nonpartisan regulatory agency. So, I mean, Professor Cohen, can you think of an example or two of how politics got in the way before?
GLENN COHEN: Oh, yeah. And as you say, it’s been bipartisan, which is interesting, right? So in 2011, FDA Commissioner Margaret Hamburg recommended that Plan B One-Step, the morning after pill, be approved for over the counter. She was overruled by then Secretary Kathleen Sebelius of Human Health Services. Right on that point, this election year, I’m sure that had something to do with it. And there’s a reason why a bunch of the FDA commissioners, I think maybe two or three years ago, got together and penned something saying say, we want to insulate FDA even more.
But I want to just kind of distinguish two questions. One is politics. Republicans, Democrats, judges being appointed by certain presidents getting involved. That is something that I think is problematic. On the other hand, FDA’s decisions are not just ones and zeroes. It’s not just data driven, in the sense that decisions have to be made about tradeoffs. Take the vaccines during COVID-19. What would be the threshold for efficacy? Would we grant emergency use authorization given the pandemic we are facing? These are hard questions that are tradeoffs, and there are costs and benefits to the way you go. But FDA is the body that Congress has appointed to make these decisions, and we want it making these decisions. Not a single judge without any scientific training sitting in Texas.
CHAKRABARTI: So we’re going to come back to that in a second. But on the sort of bipartisan efforts to inject politics into FDA’s decision making, actually, our producer Paige reminded me that back in 2014, I actually had done an interview about a governor. Specifically Massachusetts Democratic governor at the time, Deval Patrick, who tried to overrule FDA’s approval of an opioid called Zohydro because of the massive opioid epidemic in the state of Massachusetts. But this was an FDA approved drug, and so the governor tried to ban it. But a month later, a federal judge ruled that the ban was unconstitutional, saying the state did not have the power to overturn a decision by the FDA. So I spoke in 2014 with medical journalist Judy Foreman about this.
JUDY FOREMAN: To my mind, it doesn’t really make sense for any governor in Massachusetts or anywhere else to sort of try to second guess the FDA, because … controversial as it was, they did go through a long process at the FDA. And they also did write a report saying they thought that the drug was safe and effective. Obviously, people are arguing about that. But I don’t really think it’s right for a governor to do it, because it really is a public health problem, not a governance problem.
CHAKRABARTI: Now, the then FDA commissioner, Margaret Hamburg, had told Massachusetts officials she was worried about the precedent that this kind of action by a governor could take. I mean, Eva, what are your thoughts about that? Sounds a bit familiar.
TEMKIN: Yeah, I mean, I think that Dr. Hamburg was quite prescient, right? And here we, we see it again … states imposing restrictions on access to medication in a way that really interferes with the congressionally delegated role of the FDA. And I think the point still holds that a state really can’t stand in the shoes of the FDA to impose restrictions on medication access that FDA has determined are not appropriate. And that upset that careful balance that Congress directed FDA to strike.
CHAKRABARTI: Now, I want to underscore that this lawsuit currently going on in Texas, as we’ve been talking about, is about a drug that’s already been approved. I feel like we have to just emphasize that it has already been approved. It’s been on the market for the 20 years that we’ve been talking about. So for a moment, Professor Cohen, again, let’s hypothesize about what might happen if the judge does indeed say … yes, I will issue this injunction against mifepristone. Could that provide the legal precedent for groups to target other drugs that are already on the market for, I don’t know, say any number of things?
COHEN: Absolutely. If the view is that the judge says it’s proper for me to relook at the evidence and essentially overrule FDA, why not use that for gender affirming care drugs or any other kind of drugs that might be used in controversial cases, contraception and stuff like that. So that’s why I think this is such a case that everybody is watching, because it might set a very dangerous precedent.
CHAKRABARTI: Eva, what are your thoughts about that?
TEMKIN: I completely agree with that. And I think, you know, we’re not just talking about controversial drugs here. There are dozens, maybe hundreds of drugs that have potential reproductive toxicities and other kinds of toxicities. Everything from cancer drugs to acne drugs to immunotherapies that have the potential to have some sort of negative impact on pregnancy or otherwise. Almost all drugs have the potential for toxicity.
That is why FDA does this careful balancing between risks and benefits. And I don’t think we want to be in a position where drugs can’t be developed or become too costly to develop or shouldn’t be made available to patients, because there might be some potential toxicity that arises. Rather, I think where the benefits outweigh the risks, and that has been determined by appropriate scientific expertise, that’s sort of where we need to be.
CHAKRABARTI: Well, as we round towards the last few minutes of this conversation, let it be said that I think virtually everyone who’s been watching this case thinks that it’s likely to end up before the Supreme Court. Now, whether or not the Supreme Court decides to take it up is a different story, but it’s headed in that upward direction. And so we spoke with Robin Feldman, a professor at the law school at the University of California, San Francisco. And she believes that landing before the Supreme Court was always the plaintiffs original intention.
ROBIN FELDMAN: I would say that the case is designed to appeal to the types of issues that the Supreme Court is comfortable taking. That is, it’s framed in the procedural context, not in terms of the substantive value of the decision. It is carefully crafted with the justices in mind.
CHAKRABARTI: Professor Cohen, not just the justices, but some very particular ones who have already openly expressed disdain for the administrative or regulatory state. Am I not right?
COHEN: Yeah, there’s a bit of a perfect storm here that we’ve got a bunch of justices who don’t like the administrative state, a bunch of justices who don’t like the abortion right. Interestingly, two of the more conservative justices, Justice Thomas and Justice Gorsuch, are on record being against nationwide injunctions. So it will be interesting to see how that plays out. But I think, you know, it’s a question about whether the court is willing to go there. You know, requires five votes and whether they can count up to five is the question.
CHAKRABARTI: Well, but tell me a little bit more about really what the Supreme Court in its current makeup has said or acted upon when it comes to issues of how much should judges and states be allowed to control or undermine regulation versus the protection of federal agencies.
COHEN: So we have, I would say, several broad battlefronts on the administrative state. There’s a question of deference to the administrative state and to agencies that’s sometimes called the Chevron doctrine. And there’s been pushback on that.
There’s something called the major questions doctrine, which is whether you believe Congress intended to give this to an agency at all. And then there’s just a general kind of skepticism of expertise. And we saw this a little bit in the OSHA mandate case about vaccine mandates last year, I think it was. So I think all of these are kind of aligning with some anti-abortion feeling on the Supreme Court in a way that makes this a particularly good moment for the challengers to bring this case.
CHAKRABARTI: I keep in mind that we purposefully started this show with the story that led to FDA’s expanded power to regulate and approve pharmaceuticals in this company. And that was a global medical disaster because of thalidomide. Now, could any weakening of FDA’s oversight opened the door to … chaos in terms of determining how do we even determine what is safe in this country?
TEMKIN: I hope not. But I think we have to seriously consider the ripple effects, depending on what the judge in Texas does, really having some drastic implications for drug development and also whenever drug development is affected for patient access. It’s really important to remember here how much it matters to people to have the FDA imprimatur of safety and effectiveness on all of their drugs.
And I think we don’t want to land in a place where that changes, where that FDA approval is less meaningful to patients, less meaningful to drug companies, less meaningful to investors. All of those things. FDA has been the arbiter of safety and drugs for almost the last hundred years, and people really count on that.
New England Journal of Medicine: “Alliance for Hippocratic Medicine v. FDA — Dobbs’s Collateral Consequences for Pharmaceutical Regulation” — “A lawsuit contesting the FDA’s approval of mifepristone could restrict access to medication abortion by removing the drug from the entire U.S. market.”
This article was originally published on WBUR.org.
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