FDA REMS Change for Abortion Pill Creates Opportunities, Questions for Pharmacists

Although the FDA has now allowed retail pharmacies to dispense mifepristone, a drug used for medicated abortions, questions still remain about the requirements for pharmacies and the availability of the drug. In an interview with Pharmacy Times, Ron Lanton III, Esq., reviewed some of those questions and what they mean for pharmacies.

Aislinn Antrim: Hi, I'm Aislinn Antrim with Pharmacy Times and I'm here with Ron Lanton, partner at Lanton Law, to discuss last week's FDA announcement of new REMS requirements for mifepristone, which is used for abortions. So, the FDA has changed the REMS requirements for this, now allowing it to be dispensed at retail pharmacies. So how is this a shift from the previous requirements?

Ron Lanton III, Esq.: Well, it's definitely a shift. The FDA this month changed regulations to allow retail drugstores to dispense mifeprex, so long as they complete what's called a REMS certification process. So, the FDA, as you mentioned, dropped a long-standing rule that required patients to obtain the pill in person at clinics, hospitals, and other certified health care providers, so the drug could be dispensed only by a few mail order pharmacies or possibly by a specialty certified doctor or specially certified clinic.

So now that's changed. Patients will still need a prescription from the certified health care provider, but any pharmacy that agrees to accept these terms under the REMS program—and abide by the other criteria, which I'm sure we'll talk about later—they can dispense those pills in their stores or by mail order.

Aislinn Antrim: Wonderful. Why was this decision made?

Ron Lanton III, Esq.: Well, this definitely was due to the Supreme Court decision that happened last year, [which] was the Dobbs v Jackson's Women Health Organization. For short, it's just the Dobbs decision for me, I'm sure a lot of people will just recognize the Dobbs name and understand, because it was such a significant case. The facts were that the state of Mississippi had banned abortions at 15 weeks, which is pre-viability, and viability referring to the fact that this fetus can survive outside the womb. So, in Dobbs, we had Roe v. Wade and we had Casey v Planned Parenthood, which were both overturned by the Supreme Court, on the basis that abortion at any time was not protected by the Constitution. That was what the difference maker was. So basically, the court ruled that the states could ban abortion at any time, as the states control the outcome. And needless to say, you know, with that groundbreaking precedent shift, I mean, that had been the law of the land for such a long time. What were people going to do now? Because not everyone lives in a state that had equal or protected rights for abortion. You know, there were states that were way more conservative, and there were states that weren't. So, it just really came down to where you lived. And, you know, fortunately, I think people are going to take a look at this drug and see how they can do this amongst all the weird legal challenges that are that are existing right now.

Aislinn Antrim: Definitely, and you and I have discussed those challenges quite a few times. So, of course, as you said, this comes after a lot [of confusion]. Some states are doing some things, some are doing different things. How could all of those differences affect this change and the availability of this drug?

Ron Lanton III, Esq.: I think a lot of that is unknown, right? I think we kind of know, now, which states are going to object. It's kind of a trend, they've been the same conservative states that had been there before. So, I think, as you look at the landscape of where we are, many anti-abortion states have laws on the books that do stipulate that mifeprex must be prescribed or taken in person, or that it can be taken only through the seventh week of pregnancy, rather than the tenth, which is what the FDA allows. So, there's definitely going to be some conflict on that. Lawmakers in about half a dozen states have introduced legislation last year that would ban mifeprex entirely. We may see that increase this year. So, it's just something to watch out for, as now states start to come back and start the new legislative sessions. I know you and I have talked about how states would try to preempt drugs or this drug that was approved by the FDA. And it's probably going to come down to the state's argument of the 10th Amendment and their rights under that, versus the federal government that's going to say, hey, it's the Supremacy Clause. And I'm pretty certain that the federal government is going to win based on the Supremacy Clause, on top of the fact that this is a drug that the FDA has already approved. And the last thing that I think that you know, it's really going to come down to is the practice of medicine itself. You know, what does the State Board of Medicine allow a physician to do and not do when it comes to abortion?

Aislinn Antrim: Definitely. Do you anticipate that retail pharmacy chains will kind of choose to selectively make this available where they can? Or could those restrictions and confusion make them more likely to just kind of say like, nope, we're not doing this anywhere?

Ron Lanton III, Esq.: Yeah, well, I think that pharmacies are going to take their cue from what happened with Walgreens and CVS. So, this month, Walgreens and CVS have put out a press release and they said that they were going to sell the abortion pill after the FDA decision rule change. The decision is going to significantly expand access to mifeprex in states where abortion is legal and that's the key: Where abortion is legal. They can't offer the pill in states that have completely banned the abortion. So, it really comes down to where you live. And that's where you're starting to see some of these legal discussions around mail order, and also around whether a mobile clinic, like a truck, can come down to the border of a state that does allow it versus a state that doesn't and then whether or not, you know, the patients are going to be able to come across that border and take it, in a neighboring state that's actually allowing patients to go across that border and get access to that medication. So, I think that's something we're definitely going to watch.

Aislinn Antrim: Very interesting. So, as you mentioned earlier, the updated REMS program does have very specific requirements for pharmacies. So, what are these?

Ron Lanton III, Esq.: It does, so I want to make sure that I read from the FDA here, so everyone has an understanding of exactly what's going on and what they're asking people to do. So, the mifeprex REMS program requires all pharmacies that dispense the drug to be specially certified. Now, the pharmacy certification requirement incorporates pharmacies and ensures that pharmacies are aware of and agree to follow the applicable REMS requirements. And it also ensures that the drug is only dispensed pursuant to the prescriptions that are written by certified prescribers. Now, any pharmacy that wants to meet those requirements of different protocols in the REMS program is eligible to be certified.

So, what are those steps? To become certified and dispense mifeprex, the pharmacy must do 4 things. One, be able to receive prescriber agreement forms by email and fax; 2, to be able to ship mifeprex using a shipping service that provides tracking information; 3, designate an authorized representative to carry out the certification process on behalf of the pharmacy; and lastly, ensure that the authorized representative oversees implementation and compliance with the REMS program, which includes the completion of the pharmacy agreement form. So as long as they do all of those steps, they should be fine. And you know, just make sure that there are no restrictions in your respective state regarding abortion, so you have to keep an eye on that. And also, I know we had said in the past, just really have the pharmacy keep an eye on the Board of Medicine when it comes to this issue so they can kind of forecast how far they can go or what they can talk to their prescriber about, what things they can and can't do.

Aislinn Antrim: Absolutely. Of course, critics have said that dispensing mifeprex from retail pharmacies can endanger patient safety. Is there any evidence of this?

Ron Lanton III, Esq.: Well, I would love to comment on that. But I'm not a pharmacist or doctor or anything like that, so I think I'm going to leave that for one of them to answer and just stick to the legalities.

Aislinn Antrim: Definitely. Well, is there anything you want to add or anything that I didn't touch on with this?

Ron Lanton III, Esq.: No, I think this was really good. I think we hit all the high points. I mean, that's really what it's going to come down to, is how is the state going to approach the issue? What are they going to allow the Board of Medicine to do? And that's going to set off the chain reaction of whether a pharmacy can actually come in and dispense. So, keep watching your state legislatures because this is the beginning of the year. And you can just kind of see if they're going to pass something more restrictive, less restrictive, which it, you know, really depends. People are changing this. They're taking a look at their statutes and seeing what they could do. So just be aware.

Aislinn Antrim: Definitely. Thank you so much for explaining all of this so well.