Although this should be a relatively routine process, the national conversations around abortion and contraception have brought more attention to the decision.
In an interview with Pharmacy Times, Ron Lanton III, Esq., partner at Lanton Law, discussed the recommendation from an FDA Advisory Committee this week for Opill birth control pills to make the switch from prescription to OTC. Although this should be a relatively routine process, Lanton said the national conversations around abortion and contraception have brought more attention to the decision.
Aislinn Antrim: Hi, I'm Aislinn Antrim with Pharmacy Times. I'm here again with Ron Lanton, partner at Lanton Law, to discuss the latest updates on this switch with a certain birth control pill from prescription to OTC. So, this week, an FDA Advisory Committee decided that the benefits of OTC birth control outweigh the risks, at least with regard to this one specific pill. So, can you discuss what sort of regulatory shift this would be and what this looks like?
Ron Lanton III, Esq.: Yeah, I don't know if it's like a big regulatory shift. Because when I was looking at this, I think we still have to kind of look at this as just a regular prescription drug. I don't know if this is going to be a huge shift because if this is just a prescription drug, without looking at what it is, it's following the same pattern as anything that wants to go OTC. I think that this is just so loud because there's been so much political noise about this decision, especially with the Dobbs [Supreme Court] decision and everything that's happened with the Supreme Court recently. But, you know, when you look at everything, the FDA has been debating this drug for a long time, and whether it should be OTC or not. I think the difference is that it's just going to bring a different category to OTC, which again, that's really what increased access does and that's why the FDA has this available.
So, when you really look at the process about how a medication goes from prescription to OTC, there's 2 things that the FDA looks at, whether it's a full switch or a partial switch. So, if it's a full switch, then the sponsor switches the drug that's covered under the NDA to a non-prescription marketing status in its entirety. And if it's a partial switch, then the sponsor partially switches some of the conditions to a non-prescription marketing status. But in this case, you had the full switch. When I went back to look at this, I thought it was very interesting about how this happened. So, HRA Pharma, which is a Perrigo company, actually did the request to a full switch, but when you look at the history of Opill that was first approved for prescription use, I believe it was around 1973, it was a Pfizer pill. And I think Pfizer discontinued it around 2005-ish. I don't think there were any safety things around it, I just think they made a decision not to do it. Whereas HRA picked the drug up in 2015 and they had the full intent to actually make this available through the full switch. So, they had to use that entire time to do the studies and so forth, to tell the FDA how this is going to happen. So, I think again, because we're talking about birth control and, you know, in light of everything that's happened with Dobbs, a lot more attention is focused on this area about what's going to happen next, because there's been a lot of unprecedented activity about what's happened since [the Dobbs decision]. But yeah, I think like I said, if we just look at this as just a regular prescription drug, this is pretty much par for the course.
Aislinn Antrim: Very interesting. So, this has been a long time coming. What do pharmacists need to know about the potential for an OTC birth control option?
Ron Lanton III, Esq.: Well, this was a recommendation, so we're going to see if the full [decision] from FDA is going to come—that decision is going to come this summer. So, I think until then, if I was a pharmacist, I would just keep watching the FDA and seeing what that is. And if it is what we think it's going to be, the FDA is going to have instructions about what everybody should do. So, if I was the pharmacist, I would just keep my eyes on the FDA.
Aislinn Antrim: Definitely. How could this recommendation and the potential ruling this summer intersect with all of the recent state legislation that we've been discussing around abortion and potentially birth control, and all of these discussions going on?
Ron Lanton III, Esq.: Yeah, that's a really interesting question. I think in order to answer it, it's important to highlight the difference between mifepristone, which was the abortion pill, and Opill, which is actually for birth control. So, these are 2 different issues [and] 2 different laws that govern them. Right? So, abortion was overturned by the Dobbs decision, which we've talked about at length through all these different interviews. And that was overturned. That overturned Roe v. Wade and it also overturned Casey v. Planned Parenthood, [and] gave the states the power to legislate abortion. When we're talking about birth control, that's when we're talking about Griswold v. Connecticut—I believe that was the case back in 1965. That ruled that the Constitution actually protects the liberty of married couples to buy and use contraceptives without government restriction. Now, I'm going to play devil's advocate because this is Pharmacy Times. We don't have anything that says birth control is actually a protected right. So, I bring that up because the FDA recommendation makes it easier to access birth control through this recommendation. And then if they follow through on the stuff that I think they're going to follow through on this summer, it’s going to make sure that that's what it is.
We've seen a lot of different states recently that have made a lot of efforts to make abortion very restrictive in their states, right? The question is whether or not that's going to extend to birth control, whether they're going to, say, tie this back to Dobbs and say, well, birth control is not a protected right. I can't believe that we're at this stage, too, because, you know, we've had a long precedent of settled law with Roe, and then that was overturned, and a shock to everybody. So now that that's happened, you kind of have to think, ‘Okay, well, that just can't possibly happen’ to ‘Well, maybe it could.’ So, if we're looking into a crystal ball, I think if we're going to try to tie those 2 issues together, that's probably where we would see a state maybe test the limits and pass a bill or something that says that about birth control. So, we just have to continue to monitor the states and see what happens.
Aislinn Antrim: Yeah, very interesting. Are there any legal or liability issues that pharmacists should just be aware of, with regard to OTC birth control?
Ron Lanton III, Esq.: I can see where there might be heightened anxiety about this because different states have different roles. And, you know, it just depends on where you're at. I think that if I were a pharmacist right now, I would really just keep paying attention to the Board of Pharmacy, just to make sure to see if there's any relevant rules. One [other] point: I would also keep my eye on the Board of Medicine. And that's something that a lot of pharmacists don't really look at, because why would they? It’s a different, you know, field. But with this, it just might be good to just kind of have a sense of how doctors are being regulated in this aspect. Just to get a sense from a risk management perspective of what might be coming next or how they might interact with doctors. That would just be my recommendation.
Aislinn Antrim: Absolutely. Some scientists have expressed concerns about whether the pill can be effectively switched from prescription to OTC. Do you have any insights into the challenges or what their concerns are?
Ron Lanton III, Esq.: Not really, other than what was publicly disclosed. So, I mean, you had a lot of the outside experts that were confident that women of all ages could use the drug without seeing a doctor or whatever their health care provider was. That viewpoint was kind of versus the criticisms internally that we've been hearing about on and off with the FDA, and the scientists that talked about, not so much the safety, but it was whether or not someone can understand and follow the labeling instructions. And that's what Perrigo was really trying to do when they were trying to make this part of the full switch, I think. But when those debates kind of went back and forth, we saw because the FDA put out a unanimous recommendation that they were going to go ahead and go forward and see where this lies. So, I think that even though there were 2 sides, I think the benefits outweighed the risk of not having this pill available to the public.
Aislinn Antrim: Definitely. This recommendation only applies to Opill. So, is there any potential for other birth control options to also make this switch?
Ron Lanton III, Esq.: Yes, I think this has opened the door to everything. It just depends on, you know, that sponsor. Again, that I was talking about if it's a full or partial switch. I think it depends on the effectiveness of the drug, how long it's been on the market, is it low hormone? That's something else to look at. I'm not a doctor, I'm a lawyer. And, you know, I can say what I think. I definitely think that, you know, that's what the goal is, is to increase access. So, if you've had one, you're likely going to have other sponsors come on and say, ‘Well, maybe we should be OTC as well.’ But I think that's an FDA decision. I'm glad that they get paid to do that and take a look at everything and, like I said, see whether or not it's effective. And if it's low hormone, and what all of that is, and if they decide that ‘Yeah, you know, maybe we should let it out’ just like they did Opill. We're going to make that decision.
Aislinn Antrim: Wonderful. Is there anything you want to add?
Ron Lanton III, Esq.: No, this is very exciting. It seems like we're having a lot of different policy discussions. I mean, we've had 2 this week on 2 different things, but they were kind of related. So now I think this is interesting, and we just have to keep waiting to see what happens. That's what makes this this and just the law itself very interesting.