SART Fertility Experts - Who Regulates IVF? A Conversation with ASRM's Chief Advocacy and Policy Officer Sean Tipton

On the SART Fertility Experts podcast, Dr. Timothy Hickman interviews ASRM Chief Advocacy and Policy Officer Sean Tipton about how IVF and assisted reproductive technology are regulated in the U.S., including FDA oversight, CDC reporting, SART standards, physician certification, laboratory accreditation, and the patient safeguards guiding modern fertility care.

All right, this is Timothy Hickman, past president of SART, the Society for Assisted Reproductive Technologies, and today on the IVF Experts podcast we're going to talk about regulation of ART, in other words, assisted reproductive technology and in vitro fertilization. We have here today someone that many of you know and are really appreciative of all the contributions he's made to our field, Mr. Sean Tipton, who is the chief advocacy and policy officer at ASRM, the American Society for Reproductive Medicine. So Sean, let me, first off, thank you so much for coming today, I really appreciate it.

Happy to be here, looking forward to the discussion. So I will say that sometimes we, for one thing, our field of medicine is unique to news stories. In other words, you think about what a small piece of the whole medicine pie we are, you know, there only were about a tenth the number of neurosurgeons in the United States, yet the headlines in the news for our field are incredible.

In other words, we have a very big space that the U.S. is interested in. We, at the last presidential campaign, IVF was mentioned time and time again. So what we want to talk about today is regulation in this field.

In other words, some of the articles we see say this is the wild, wild west of medicine. How would you respond to something like that? You know, I used to be more gracious, but as I've gotten older, I guess I don't have time for that. And so I think anybody who says that IVF is unregulated is either woefully uninformed and shouldn't be talking about it or maliciously deceptive, because there's absolutely no truth to that comment.

IVF is actually unique in American medicine. It is the one medical procedure that if a physician in the United States performs it, they have to report that fact to the federal government and report on its outcome. No one else has to do that.

And so on top of the base of regulation of assisted reproductive technology and reproductive medicine being the same as it is for every other kind of medicine, which is fairly complicated, we can talk about that in a second, I think it is very important for people to understand it is the only medical procedure that has to be reported to the federal government. So to talk about that being unregulated is just completely wrong. It's really too bad that it's mischaracterized like that.

Let's kind of go through the different layers of regulation, because there are certainly many within the field. Do you want to address a few of them? Sure. So medicine in the United States is a complicated patchwork quilt approach to oversight and regulation.

And if we start with the federal government, the federal government through the Food and Drug Administration has to approve all the drugs and devices that get used by physicians in practice. That's true in this space as it is true for everything else. So if a pharmaceutical company has developed a new drug that they think will help patients and they want to market it, it has to go through the approval process of the FDA, which is quite rigorous.

And I would argue that the oversight through the FDA is really the envy of the world. It's done very, very well. The FDA also regulates tissues.

In this case, for example, requiring infectious disease testing of sperm and eggs and having certain standards about storage of those tissues as well as frozen embryos. So and those happen. You know, there are, as I'm sure you know, there are surprise inspections.

The FDA will come knocking on your door and come and see your facilities and check your records and do all those kinds of things. So that's an important piece of it. Through the Clinical Improvement Act, as administered by the Centers for Medicare and Medicaid Services, they regulate some aspects of the laboratory process, particularly like the blood level, the hormone level test through blood that the patients go through.

Those are regulated by CLIA, another part of the federal government. And then not as much of a regulatory aspect, but the National Institutes of Health oversees and provides funding for research support in the field. And then as we started at the top, talking about the fact that all IVF cycles have to be reported to the federal government, that goes to the CDC, the Centers for Disease Control and Prevention.

And SART works to collect the data from its members to help them comply with that law that is currently in place. So the CDC collects all that number. Now, given some of the current realities of the CDC, we don't know what they're going to do with that data currently, but I think it's important for people to understand why that is required by federal law.

SART was in the data collection and reporting business well before Congress decided it was a good idea and well before the CDC started doing its reports and will be doing that even as the CDC has some issues of being able to get those reports out. Now, at the state level, the licensing of professionals is done by the states in this country. So that means physicians, nurses, lawyers are licensed by the state government.

So the people who have direct patient contact have that. Now, one thing that people don't appreciate, I think, about that is that any licensed physician can really sort of legally do almost anything they want. The specialization regulatory basis is from the third leg of the triangle of oversight in this country, and that is professional self-regulation.

So you'll hear the talk about being board certified. What that means in the case of IVF practitioners is they are certified by either the American Board of Obstetrics and Gynecology or the American Board of Urology, and there's a special certification in the reproductive endocrinology and infertility. So that's a very rigorous process overseen by the boards, and the oversight is really done by the peers of these physicians.

And not only that, but there's another level of oversight there, the American Board of Medical Specialties, which makes sure that all these individual boards are operating in a transparent and upright manner. So it's really three legs. It's federal regulation, state regulation, and professional self-regulation.

That latter component is fairly unique to the United States, but it's very, very important and very, very powerful. We should probably go ahead and talk about what SART brings to the table. So SART is even a higher level than that, almost about, what is it, 95% of all the IVF cycles done in the U.S. from SART clinics, and SART has another set of standards.

You want to address that a little bit? Yeah, I think it's very important for patients. Patients often ask, how do I find a good, reputable IVF practitioner and clinic? And we say start with SART. So you should make sure that your clinic is a SART member.

If your clinic is a SART member, you're going to know certain things. You're going to know the medical director has the appropriate credentials, an MD, a board-certified reproductive endocrinologist. You're going to know the laboratory director also has appropriate credentials and certifications.

You're going to know the facility meets certain standards. You're going to know that they are bound by rules that pertain to how they report their outcomes and how they do their advertising. And I think that's very important.

It's hard, I would argue, almost impossible for a patient to try to sort through some of this and figure out who are the reputable practitioners, and that is sort of what SART does for you. But SART works very actively to improve their members who may be struggling to meet some of the standards. And occasionally, SART has to remove members because they're not up to snuff or they don't want to play by the rules.

And so I think it's very valuable to patients to understand that there's at least some oversight there that they can rely upon. Absolutely. I would say also there is a certain certification you have to have within the laboratory to be a SART member, either a CAP accreditation or a joint commission accreditation.

Those are very, very rigorous standards that one has to abide by. And again, that is on top of the FDA regulations. So we actually, SART has had some experience trying to work with some state governments on laboratory accreditation, and we have found they're not, they weren't really up to snuff.

It's a very complicated thing. So you have to have the CAP and the joint commission allow people who actually are in the field and really understand the substance, and that provides an important layer of oversight. Excellent.

I would also state there's one other thing that makes our field unique in this situation, and that we deal with metrics, metrics in our field. In other words, it's pretty clear cut what our successes and our non-successes are. You either are pregnant and have a baby, pregnant and have a miscarriage, or you're not pregnant.

As opposed to, let's say you break your arm or something like that, and how would you judge an orthopedic surgeon setting that arm? Is it fully functional? Is it not? Is that not exactly the same? So our metrics are quite clear, and with using all of those type of metrics that we have in our field, plus these multiple layers of regulation, it's just almost silly to think that we're not a regulated group. And it's interesting, other fields of medicine, I mean, there's some, you know, Medicare has numbers on patients who have to get readmitted after a procedure to a hospital that can let patients see some of that, but it's fairly rare and often pretty obtuse. And yeah, it's a very clear outcome from an ART cycle.

And I think you do see sometimes people touting other ways to approach family building, and they are not always as transparent as to how they articulate those numbers. So for example, they will try to compare the success rate of a single IVF cycle with five years of treatment that some, that goes through a number of other treatments. So I think it's important for patients to try to be as discerning as they can.

And on the SART website, there's actually a lot of material that can help people understand that. Well, I think that's a really thorough discussion of these regulatory agencies within our field. Any last comments you have for us? You know, Tim, you opened with talking about the high visibility of this field, and that's very true.

And that's, I think there's a couple of things there. One is, it is a unique field of medicine. It, at this point, at least, still requires two different people in order to make a baby.

And making a new person is the goal. And so it's different than just, I'm going to get my hip replaced and it's nobody else's business. By definition, this field deals with more than one patient.

That makes it different. And also, human reproduction is a very fundamental drive of our existence. And it also brings with it a lot of emotion.

And that can make some of these discussions a little more difficult. Absolutely. Well, again, thank you so much.

I really appreciate your time here today. And I'm sure that a lot of people will be thrilled about listening to this. Great.

Happy to be here. Thanks.