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Breaking News - Do Vaginal Dilators Require a Prescription? · Pelvic PT Rising

• 0:06
  Speaker 1: Hey guys, welcome back to another episode of the Public PT Rising Podcast with Jesse and Nicole Cozine.
• 0:11
  Speaker 2: Hey, nicole, hello.
• 0:13
  Speaker 1: Hey, some breaking news today.
• 0:15
  Speaker 2: Some breaking news today and this week.
• 0:17
  Speaker 2: You know it's not too often when we get to break news on the Public PT Rising Podcast in our small little public rehabilitation field.
• 0:25
  Speaker 2: This is the third time.
• 0:27
  Speaker 2: The first time was the new AUA guidelines in 2022.
• 0:31
  Speaker 2: The second time was the APTA position statement on chaperones and now this.
• 0:39
  Speaker 1: I mean, has anybody broken more stories than us?
• 0:42
  Speaker 2: I mean, don't pat ourselves on the back too much.
• 0:44
  Speaker 2: I just feel like it is exciting when we get to.
• 0:47
  Speaker 2: You know we are doing some investigative, journalistic kind of stuff.
• 0:50
  Speaker 2: We are making sure to, you know, not comment on this.
• 0:54
  Speaker 2: Before we had a lot of facts, which we'll go into here in a second, on how some other people were doing that.
• 1:01
  Speaker 2: But we just, you know, when something like this happens, we just want to make sure that, especially having the responsibility of this platform, that we make sure that when we do comment it is factual and, you know, level headed and all of the things.
• 1:14
  Speaker 2: So we bring that information to you.
• 1:15
  Speaker 2: But this does in fact affect our entire public rehab field and all of our patients.
• 1:22
  Speaker 1: Okay.
• 1:22
  Speaker 1: So if you're listening to this and you have no idea what the hell we're talking about, nicole, what is actually going on here?
• 1:29
  Speaker 2: Well, where have you been?
• 1:29
  Speaker 2: But at the end of the day, this is what has happened.
• 1:33
  Speaker 2: Whatever those who haven't heard, last week it was widely reported that the FDA had made a new rule that required all patients who needed a vaginal dilator to get a physician's prescription first.
• 1:45
  Speaker 2: And you know, I think that, particularly coming out in the wake of the IVF ruling in Alabama, which is a whole another thing that we need to talk about I think that we were all primed to be super frustrated and you know war on women's rights and all kinds of stuff.
• 2:01
  Speaker 2: But there was a lot about the story when we first heard and we first got our own email that just didn't add up and things just didn't make sense.
• 2:09
  Speaker 2: And so, for those of you who don't know, this was all sparked by an email from Intimate Rose stating, and I quote, the FDA is now requiring a prescription for vaginal dilators to be sold directly to patients, end quote.
• 2:20
  Speaker 2: And that went out on Tuesday for 20.
• 2:23
  Speaker 2: And I'm going to let Jesse weigh in here quite heavily on this podcast episode because, for those of you who don't know, this is what Jesse's wheelhouse is, literally what he did for 10 years before he was at Pelvic Sanity and Pelvic PT Rising.
• 2:38
  Speaker 2: Jesse, tell us what your job was.
• 2:41
  Speaker 1: Thank goodness, I found a much better boss and a much better gig over there.
• 2:45
  Speaker 1: But yeah, this is exactly what I did for almost a decade.
• 2:47
  Speaker 1: I would help companies get FDA approval in the case of drugs or FDA clearance in the case of devices, and really specialized in cases when, frankly, the FDA was being difficult or challenging and difficult things to get through.
• 3:00
  Speaker 1: So usually this was after somebody had tried themselves or tried with another regulatory council, and so I would have in my past life been hired by a company like Intimate Rose to design their studies to get their 510k approval to negotiate with the FDA if you're having an issue with this.
• 3:17
  Speaker 1: So this was definitely my wheelhouse and that's why when I read that email and I started seeing all the outrage and stuff that was sparked, it just didn't make sense, like there was a lot about it that just didn't really add up.
• 3:30
  Speaker 1: And so we started digging.
• 3:31
  Speaker 1: We emailed Intimate Rose a few times, we contacted other dilator companies, I did an online search of the updated FDA guidance and regulations, looked at the 510k submittals that had been done around this and really just kind of dove in to try to figure out what was going on.
• 3:48
  Speaker 1: And then on Thursday I posted something in the Huddle and the Pelvic PT OT Entrepreneur Group just with some real questions about what was going on.
• 3:57
  Speaker 1: So that was Thursday and then Thursday evening we got a video from Intimate Rose on Instagram and they answered some of the questions in the comments.
• 4:05
  Speaker 1: They left some of them unanswered and left us with all still, I think, a lot of burning questions.
• 4:10
  Speaker 1: So that's kind of where we're at with all of this.
• 4:15
  Speaker 1: So we wanted to now give you guys all of the details and everything else that's going on.
• 4:19
  Speaker 2: Yeah, everything that we know.
• 4:20
  Speaker 2: I will say this One of the reasons why I think we've decided to do this investigation and then also just report on it is it affects every single one of us who give vaginal dilators to patients and recommend them.
• 4:34
  Speaker 2: It affects all of our patients.
• 4:35
  Speaker 2: We've gotten a lot of increase from our patients, from other people on social media that are basically super confused as patients.
• 4:43
  Speaker 2: I mean, you think we're confused as practitioners, as patients.
• 4:45
  Speaker 2: They're like wait a second, is the dilator that?
• 4:48
  Speaker 2: I don't have an Intimate Rose?
• 4:50
  Speaker 2: Is it not safe?
• 4:51
  Speaker 2: Do I need to give it back?
• 4:52
  Speaker 2: Like what do I do?
• 4:53
  Speaker 2: Is it still okay to use?
• 4:54
  Speaker 2: And so I just feel like it's just a good reminder that people are listening to us on social media and some of the reposts and comments that were done pretty early on, right after that email was out now, especially looking back in hindsight, was not accurate, was spreading essentially some misinformation, and so just like a reminder too, that if you have a platform, if you're on social media, just be careful what you post and who it might affect.
• 5:22
  Speaker 1: And so as we dive into this, I just want to say first of all we have so much sympathy for Amanda Olson, the founder of Intimate Rose, the entire team over there.
• 5:30
  Speaker 1: I mean I know better than anybody dealing with the FDA sucks.
• 5:34
  Speaker 1: It is confusing, expensive, it's often unfair and these companies are just trying to create a good product and sell it and get it to people and help folks out.
• 5:44
  Speaker 1: And I've been there with clients when they get that knock on the door from the FDA and the FDA is hopelessly outdated.
• 5:51
  Speaker 1: It's understaffed that people who work there aren't usually very good at their jobs, because if you're a physician and you could go into private practice and make hundreds of thousands of dollars a year, why would you go and work at the FDA and push paper around the desk for 75 grand?
• 6:04
  Speaker 1: You're not usually getting the cream of the crop right.
• 6:07
  Speaker 1: So usually we would say like one out of 50 people in the FDA was good and they were there for the right reasons and everybody else were just kind of not great folks to work with.
• 6:15
  Speaker 1: And so we don't want to say any of this stuff to disparage anything Intimate Rose has done, I think.
• 6:20
  Speaker 1: I mean we've personally at the clinic, had their products, sold their products.
• 6:23
  Speaker 1: I think what they're doing is really, really cool.
• 6:25
  Speaker 1: Nicole, I know you feel the same way.
• 6:27
  Speaker 2: Yeah, and I love supporting you know, pelvic PT owned companies.
• 6:31
  Speaker 2: I think that's really awesome.
• 6:32
  Speaker 2: I think that there's a lot of thought that's been put behind all their products the rectal dilators and stuff like that.
• 6:38
  Speaker 2: Basically, all the products are great.
• 6:40
  Speaker 2: But here's what we're going to do, because I feel like there's been a lot of misunderstanding about what has happened and we're just going to go into the facts that we know and the timeline that we put together and, essentially, the recommendation of like what to do.
• 6:55
  Speaker 1: Yeah, and so I think part of our challenge with this is there was so much misinformation and this was kind of dripped out in trips and drabs and we were asking questions and I think there was a lot going on and then complicated by the megaphone of social media.
• 7:08
  Speaker 1: But, just to start off here, there is no new ruling from the FDA.
• 7:13
  Speaker 1: So what happened?
• 7:15
  Speaker 1: Intimate rows applied for and received 510k clearance, which is basically approval for a device, for a prescription device for their dilators.
• 7:24
  Speaker 1: So they now have to have prescriptions on file to sell them.
• 7:28
  Speaker 1: Right, they got approval for a prescriptive device.
• 7:30
  Speaker 1: Now you have to have a prescription.
• 7:32
  Speaker 1: Like that's how that works.
• 7:33
  Speaker 1: There is no evidence that this is a requirement industry wide or for any other company and does not apply to all vaginal dilators.
• 7:41
  Speaker 1: So let me kind of unpack that.
• 7:43
  Speaker 1: But that's the kind of the top level thing there.
• 7:45
  Speaker 1: I mean, part of what led to this was that in Intimate Roses email it did say that the FDA is now acquiring a prescription for vaginal dilators to be sold directly to patients.
• 7:54
  Speaker 1: Maybe that is Intimate Roses interpretation from their conversations with the FDA, but that is not the way the FDA has traditionally enforced this.
• 8:02
  Speaker 1: This is not something the FDA has done industry wide.
• 8:05
  Speaker 1: There's no new rule.
• 8:06
  Speaker 1: They haven't contacted many other companies.
• 8:09
  Speaker 1: So this is an Intimate Roses issue, and so I went back and actually looked at the Intimate Roses 510k submission.
• 8:16
  Speaker 1: So the company applied for that and it was granted FDA clearance for a prescription device in June of 2023.
• 8:23
  Speaker 1: So before that, there was not clearance.
• 8:25
  Speaker 1: After that, the product was a prescriptive device, and so they may have applied for that.
• 8:32
  Speaker 1: Actually, in order to make new claims, one of the things that you can do when you do this is you can actually make claims of effectiveness against vaginismus in this case.
• 8:40
  Speaker 1: So it sounds like something where they were trying to submit that and kind of do the right thing, but because they were cleared as a prescription device and not an OTC device, a prescription is required, and that should have been happening, and so it sounds like what happened is that the FDA knocked on the door and said well, wait a second, we can't have a prescriptive device and then continue to sell it directly to consumers without a prescription.
• 9:03
  Speaker 1: So that is the genesis of what is going on, and we've also done this to, just to confirm, contacted several other dilator companies, nicole, who've been really gracious to respond back to us.
• 9:14
  Speaker 1: None of them have been contacted by the FDA, none have seen anything that would change the way that their products are sold or that this would apply to them, and several of them had actually already contacted their own regulatory attorneys or regulatory counsel and had confirmed that they hadn't seen any industry wide changes.
• 9:30
  Speaker 1: So our conclusion, then, is that this is a FDA enforcement issue, specifically with Intimate Rose, because they applied for, and were cleared for, a prescriptive device, and it's not something that affects all manufacturers and it's not a new industry wide rule.
• 9:48
  Speaker 2: Yes.
• 9:48
  Speaker 2: Now just to be clear, jesse, that all is like publicly available.
• 9:52
  Speaker 2: How would you find that out?
• 9:54
  Speaker 1: Yeah, that is mostly publicly available.
• 9:55
  Speaker 1: You can go and actually see, and in the show notes of this we'll probably just put some links to some of this stuff.
• 10:00
  Speaker 1: But you can actually go and see if you Google Intimate Rose 510 case submission and click on summary.
• 10:06
  Speaker 1: The FDA's website is a little clunky so it's kind of hard to find sometimes, but that's all publicly available.
• 10:11
  Speaker 1: So they apply for it looks like in May and they were approved or cleared as it is in June.
• 10:17
  Speaker 1: Yet there was for a prescription device.
• 10:20
  Speaker 1: It was not an OTC device, so that is all pretty publicly known.
• 10:24
  Speaker 1: And then we've gotten part of the story from Intimate Rose themselves, who said that they had been contacted directly by the FDA.
• 10:30
  Speaker 1: So I'm assuming that they thought that they were doing all of the right things.
• 10:34
  Speaker 1: You know, after they had gotten clearance the FDA came in and said well, wait a second, you're not.
• 10:38
  Speaker 1: Here's what you have to do.
• 10:39
  Speaker 1: And now they're making the adjustments that the FDA has wanted them to do going forward.
• 10:44
  Speaker 1: So that seems like the way the story is.
• 10:47
  Speaker 1: We've actually reached out a couple of times to Intimate Rose to get more details.
• 10:50
  Speaker 1: Hopefully they'll get back to us at some point, but they have not as of yet.
• 10:53
  Speaker 1: So that's where all of that stuff stands.
• 10:57
  Speaker 2: Yeah, so the conclusion at that point for that section is that the this is an enforcement issue, specifically with Intimate Rose, not something that affects all manufacturers, right?
• 11:06
  Speaker 1: Yep, so I mean you should be able to do this for other folks.
• 11:09
  Speaker 1: Now, the second piece that we wanted to clarify is that if Intimate Rose is currently prohibited from selling directly to consumers without a valid prescription, this likely applies to other distributors of their products as well, and this is something that for us, as people who have distributed Nicole products for them in the past, one of the concerning statements to me and just in my kind of regulatory eye in their email was actually one where they encouraged people to buy them, clinics and clinicians to buy their products wholesale and then turn around and sell them to patients, and to me that was like a big red flag, because you can't do that.
• 11:47
  Speaker 1: That's not how.
• 11:48
  Speaker 2: Yeah, I mean that just doesn't pass the like logic test.
• 11:52
  Speaker 2: Yeah, it was like well, if you're not allowed to, why would we be allowed to?
• 11:55
  Speaker 2: Like that just doesn't make any sense, which is one of the reasons why we were like confused and questioning stuff and like what the fuck's going on?
• 12:01
  Speaker 2: Type of situation.
• 12:02
  Speaker 1: So I mean and just to flesh that out a little bit I mean, it's pretty unlikely.
• 12:05
  Speaker 1: The FTA would prohibit a manufacturer from selling directly to consumers without a prescription, but it would be totally fine for them to sell to a distributor, who then sells to consumers without a prescription, right, I mean, if that was the case, there wouldn't be a prescriptive drug stuff.
• 12:20
  Speaker 1: The pharma companies would just sell it to a distributor who could then put it in like a 7-11.
• 12:25
  Speaker 1: Right, so you know, it just didn't really make sense, and it's one question that we really have not gotten an answer to, either via email or on Instagram, where they were answering some of the follow up questions.
• 12:35
  Speaker 1: But you know, I think that it does put distributors in a pretty precarious position, and it's something that you guys might want to be thinking about if you're going to be selling these directly to patients without having a prescription.
• 12:47
  Speaker 2: Yeah, and so that's basically what our essentially call to action is, if that we can say that.
• 12:52
  Speaker 2: You know, what we would like to see is a formal statement from Intimiders regulatory council saying it is completely fine for wholesale distributors to sell directly to patients without a prescription.
• 13:00
  Speaker 2: And the issue here was like the kind of direct encouragement for us to still sell those products to patients without a prescription and that just seemed it's a little disingenuous, just not on the up and up and I'm not into that.
• 13:15
  Speaker 1: Yeah, and so that was the second big kind of takeaway is just thinking about what this means for people who have been distributing their products.
• 13:21
  Speaker 1: The third thing that I know kind of struck both of us a little bit and Nicole, I just don't like when people use a really complex thing like the FDA to like make points with people who don't really understand the background and the process.
• 13:36
  Speaker 1: But you know, I thought that in some of their announcements Intimate Rose had been implying that competitor products are less safe or less effective, they're not doing the right thing because they're not FDA cleared or because they're not being sold with a prescription and that was a couple of comments even from their CEO, in that you know, kind of Instagram live, that kind of compared this to be getting like a drug off the street.
• 14:01
  Speaker 1: That just didn't really ring true when you're implying that other people's products are not safe and effective when really it's you who's had an action by the FDA taken against you.
• 14:10
  Speaker 1: So that was something that I don't know.
• 14:13
  Speaker 1: That didn't ring really really great to me.
• 14:15
  Speaker 2: Yeah, me neither.
• 14:16
  Speaker 2: And to be honest with you, I mean, we all know we all have doctorates here we all know, like, what's safe and effective for our patients.
• 14:23
  Speaker 2: We know that they can be made of different materials.
• 14:26
  Speaker 2: We know a lot of things about dilators, and so when dilators from two different companies are made from the same medical grade silicone with the same freaking shape, with this a lot of the same things, like to say that one is not effective or to insinuate that that a company is not not doing the quote unquote right thing, when you just we're doing that same thing.
• 14:55
  Speaker 1: That's the whole thing, right.
• 14:55
  Speaker 1: It's like, oh, people are bad if they're not FDA clear.
• 14:58
  Speaker 1: It's like, well, they weren't FDA cleared until June of 2023.
• 15:01
  Speaker 1: And I don't think that they started in May of 2023.
• 15:05
  Speaker 2: So that I just don't love that and that I do have a little bit of an issue with that, because that's just not true, right, and it doesn't do well for our profession, doesn't do well for patients, and we just know that that's not true from the actual devices and the actual vaginal trainers that they are Like.
• 15:22
  Speaker 1: That's just not true, and I think it takes advantage of people's lack of understanding about the FDA process and how all of that works in order to use that to disparage somebody else.
• 15:33
  Speaker 1: It just didn't seem like the right thing when this whole thing is actually about intimate rows and their regulatory process and whatever you think about all of that, I mean they are the target of all of this, and so to turn that around and try to spin that that they're the ones who are doing everything right, when the FDA had to knock on their door and say, actually you need to change what you're doing like right now didn't come off great.
• 15:58
  Speaker 2: The other thing that I was very disappointed in was that original claim that made it seem like it was an industry-wide issue, when we know now that it's not, that they probably knew that it's not, and then to that just also seems a little bit disingenuous to me, which is I'm not super stoked about either.
• 16:20
  Speaker 1: So that is kind of our summary of the breaking news.
• 16:23
  Speaker 1: We hope that this has been helpful for you guys to kind of disentangle.
• 16:26
  Speaker 1: But if we really go back and just our big takeaway here is that this is not a new ruling, this is not something that is industry-wide.
• 16:34
  Speaker 1: This is targeted to a specific product and a specific company, the company being intimate rows and the line of products being their vaginal dilators.
• 16:42
  Speaker 1: We should also know this doesn't apply to any of their other products.
• 16:46
  Speaker 1: So we're talking about a very specific subset of everything.
• 16:49
  Speaker 1: It's not the wands, it's not the rectal dilators, it's not anything else it's not the vaginal weights, it's only the vaginal dilators.
• 16:57
  Speaker 1: Right, so that's what we've got for you guys.
• 17:00
  Speaker 1: I hope this has been kind of a helpful breaking news thing.
• 17:02
  Speaker 2: It's kind of fun getting to run around and play like investigative reporter here it is, and I think I hope that you guys know that we wanted to make sure that we had brought all the facts that we know.
• 17:11
  Speaker 2: I will point out that what we don't yet know or have clarification on, but we can extrapolate, is that if you are a distributor of intimate rows or buy their products wholesale, it probably is not kosher to be selling that to patients without a prescription and, yes, that is a barrier.
• 17:29
  Speaker 2: Yes, that sucks.
• 17:30
  Speaker 2: That probably will not be what it's like in a couple of years from now, or we don't really know the timeline, but so that's not for forever.
• 17:38
  Speaker 2: But that is probably what is the most conservative thing to do right now.
• 17:42
  Speaker 1: Right, that's really until and unless they go ahead and get a additional FDA clearance to get a OTC product, and this happens all the time in industry.
• 17:52
  Speaker 1: This is actually typically one of the ways that this goes for a lot of things, and you guys can think about this in drug terms.
• 17:59
  Speaker 1: Sometimes we're a little bit more familiar with it, but sometimes a new drug hits the market it's a prescription and eventually that gets downgraded to an OTC when they have more data, more tests, more.
• 18:10
  Speaker 1: There's just different requirements for those kinds of studies.
• 18:13
  Speaker 1: There's a whole different level of standard when it comes to over the counter products that the FDA puts out there, because you have to make sure that a normal consumer can handle the product correctly as opposed to it being the medical professional being the one who distributes it and actually tells the person how to use it in all the use cases.
• 18:33
  Speaker 2: Yeah, I mean and we know this from our public health world right, Like yeast infection medications this has been done urobell peridium, as they're equivalent in ASO, that's been done Like there's a ton of different examples of that.
• 18:45
  Speaker 2: So again, this is not something that's unique to Intimate Rose at all, but it is something that I were just not super stoked on the way that the information was disseminated to everybody.
• 18:56
  Speaker 2: So hopefully this helps you to clear up all of that and really give you the best information possible that we have at the time.
• 19:04
  Speaker 1: Absolutely so.
• 19:05
  Speaker 1: If you guys have any further questions on this, let us know.
• 19:07
  Speaker 1: If we get any other updates, we will certainly let you guys know, but as always, we wanna keep this conversation going.
• 19:13
  Speaker 2: And let's continue to rise.
• 19:15
  Speaker 2: It's the much larger issue of M&M.