Advocating for BHRT with A4PC's Scott Brunner
"We're in that education process and we need prescribers and patients to tell us their stories to reach out to their members of Congress and make sure they understand the...
INTRODUCTION: Welcome to Qualgen's podcast where we talk about all things health and wellness related, including hormones, pharmaceuticals, health trends and ways you can help better your life.
JP: Hi everyone, thank you for taking time out of your day to listen in. Today, I am talking with Scott Brunner, the CEO of Alliance for Pharmacy Compounding, otherwise known as A4PC. Scott, thank you so much for joining me today. I'm so excited to have you here with me.
SB: Well, thank you for having me. I look forward to the conversation.
JP: Absolutely. I heard about A4PC at a conference I went to a few years ago and we were just so excited to see someone there being an advocate for something we truly believe in and I really wanted to talk with you to hear exactly what you all do and why you do what you do. So let's start with an overview of the alliance. When and how did A4PC get started?
SB: Well, the organization itself has been around for just over 30 years. We were founded in 1990 really an outgrowth of PCCA. PCCA, of course the distributor in the compounding space and they saw a need at the time to have an entity that would serve as an advocate for the profession. Now, as you may guess, over 30 years, we still have a relationship with PCCA but we are an independent organization. We're a not-for-profit business trade association and our sweet spot is advocating for 503A and 503B pharmacy compounders. We changed our name prior to January of 2020 we were the International Academy of Compounding Pharmacists. So, we rebranded almost two years ago really with the idea that we wanted to represent a broader swath of pharmacy compounding than just pharmacists. At the time, we had technician members, we had educators who are members. The other dirty little secret was that we weren't really terribly international. And so, we changed our name to Alliance for Pharmacy Compounding. We broadened our membership categories so that now, not only compounding pharmacists and technicians are our members but certainly educators, supply chain professionals, even prescribers and some patients are members of the alliance and what we do is represent the interests of those folks and assuring that millions of Americans who benefit from compounded preparations can continue to access and afford those preparations.
JP: That's amazing. So, for those that don't know, you mentioned 503A and 503B compounding pharmacies, can you just explain in your terms the difference on those and the importance that they have on individuals?
SB: Sure and those are categories 503A and 503B are sections of the Food Drug and Cosmetic Act. So, we refer to them that way because that's the section of the statute where they are established. A 503A compounding pharmacy is a traditional compounding pharmacy. It may be a pharmacy that's exclusively compounding, it may be a hybrid pharmacy that's doing some retail. It is likely the pharmacy on Main Street in small towns across America that are serving patients based on a prescription that a physician or nurse practitioner or a PA has prescribed. So 503As, under federal law can only dispense compounds pursuant to a prescription. 503B is, they're also called outsourcing facilities, but they do compounding and it's usually smaller amounts of compounding. But they are able to distribute compounds to hospitals, to specialty clinics, et cetera without a patient specific prescription. So, think about the situations where the need for a physician, maybe you're an ophthalmologist doing cataract surgery and there's a compounded preparation that you rely on in treating those patients during those surgeries. You may keep a quantity of that in office so that you can use it in the context of the procedure. They distribute to those medical facilities without a specific patient in mind and the hospital or the clinic is able to keep a small quantity there to administer whether there's an urgent need or some sort of special use in the clinic
JP: Right - just makes it so much more easier for them.
SB: Yeah. Right.
JP: So what issues do you see compounding pharmacies having currently?
SB: Oh goodness, right now, so many of the challenges that affect patient access to compounded medications are rooted in what we perceive as overreach or corner cutting or even in some instances manipulation of data, but the FDA. That sounds harsh. I don't mean it to sound harsh. Congress has stipulated in law a place for pharmacy compounding. It says it has carved out that 503A and 503B and said these are an essential part of the American drug supply chain, the American health care system and yet we have an FDA that appears to seek at every turn to restrict pharmacy compounding in a way that the law does not suggest or certainly say overtly and so you ask about issues, some of the issues we're dealing with. Certainly one right now and I suspect we'll talk more about this is FDA is implicit threat to restrict compounded hormone therapy. Therapies that serve millions of Americans, not just women but women and men, members of the trans community, et cetera. Based on a study that FDA commissioned, they are saying now they will base across the board restrictions of compounded hormones. That's really problematic goes much farther than Congress has suggested that FDA should. And FDA is basing it frankly on bad science. So that's one. We see the Center for Veterinary Medicine at FDA looking to restrict animal compounding from pure ingredients or from bulk ingredients. We have a draft GFI that came out about a year and a half ago. Certainly we and others have commented but it would require that compounding for animals begin with manufactured drugs. That's problematic for a lot of reasons and the first one that may come to mind is cost certainly a compound made from manufactured drugs is likely to cost more. That's not really our concern. It's more about accuracy when you compound from a manufactured drug. Federal law, the FDA regulations allow a certain degree of variability in the potency of that drug. It may say 10 mg but there could be a range of 10 to 15% in terms of the dosage. So, a compound or compounding from a manufactured drug starts not knowing for sure what the strength of that manufactured drug is. So, it also suggests that we really believe that it interferes with the ability of veterinarians to use their medical judgment in prescribing for their animal patients. So that's a big one. Another one that we're working on is really an opportunity and I have to give FDA some credit back near the beginning of the pandemic. The FDA began to realize that hospitals were unable to source a number of covid drugs. So putting a patient on a ventilator, a lot of those drugs, the supply chain had already was already beginning to break down. They couldn't get those they issued at our request at APC’s requests emergency guidance that would allow 503A's under strict regulatory guidelines, had to be in cooperation with the approval of their state board of Pharmacy, could source 13 specific covid drugs that were in shortage directly to hospitals. We thought that was good FDA did the right thing. We appreciate them doing that now that we're on the tail end of the pandemic and we have continued to experience supply chain problems. We ought to make that ability of 503A's to source shortage drugs not only to hospitals but to specialty clinics permanent. In other words, there ought to be a narrow path where a 503A can source to those clinics urgent use or emergency need drugs when the clinic can't get it from a manufacturer or cannot get it from a 503B. And so, we have a piece of legislation we're supporting in Congress, it's HR 3662 that would make permanent that path and it would basically allow 503As to do that - again, strict regulatory guidelines for any drug that is on the FDA drug shortage list or the ASHP drug shortage list. It is gathering support in Congress. FDA though, bafflingly has already come out and said they opposed it - it wasn't necessary that the 503Bs could fill that need. And of course, I reply is if the 503Bs could fill that need, why didn't they during the worst of the pandemic? So those are just three issues. There are others we are working on, but those are the three that come first to mind.
JP: I just with the last thing you said. You know obviously Qualgen is a 503B and I don't think the public knows how hard they make it for compounding pharmacies to create product.
SB: Well, and that is that is the irony of this model. We strongly support 503Bs, but I would suggest to you that FDA has done little or nothing to create a business model that is sustainable for 503Bs. So, for instance, they've created their Center for Excellence. We think that's wonderful. They are looking for ways to help grow the 503B market. And yet in terms of the bulk positives list and the negative list and all that they've done nothing to stimulate that market. And so, we believe that there is going to have to be some work by FDA to create a sustainable business model. So when I talk about drug shortages, part of the problem with 503Bs is not that they don't want to create to prepare those drugs that are in shortage, it's that there's no economic model that works the time that it takes to do the cGMP testing and all of that, the turnaround time for the labs to be able to retrofit and create those just doesn't exist. So, we've got to figure out better ways of empowering 503Bs to meet what is a legitimate need in the drug supply chain.
JP: Yes. Absolutely. And I know you touched on the BHRT earlier which for anyone who doesn't know BHRT stands for bio identical hormone replacement therapy. So, can you explain that ongoing issue a little more in depth and how it could affect individuals who are currently receiving this treatment?
SB: Absolutely, and if I may put on my salesman hat, I would urge anybody interested in this issue to go to compounding.com. It's an APC website that really spells out what's at stake in terms of FDA’s threat to restrict compounded hormones, but it also gives patients the ability to tell their compounded hormones story and to share it with members of Congress. So, 2019 FDA commissioned the National Academies of Science Engineering and Medicine to create a report about compounded hormones. And the FDA touted it as independent it was going to be a third party that was doing it and then FDA turned around and stacked the deck not only biasing the study from the front by saying we believe these are unsafe and leaving the sense with the NASEM study group that they were expected to present a report that demonstrated that compounded hormones were unsafe, but FDA also recommended the members of the study group that NASEM put together many of them, in fact none of them had any expertise in prescribing or compounding bioidentical hormones. So put together a great group of physicians and others researchers and others with no expertise in what they were purporting to study, they issued the report and surprise. It calls for across the board restrictions in compounded hormones. Never mind that the study only looked at two or three hormones and those that it looked at DHDA and some others are not hardly the most prescribed compounded hormones out there, but based on this very flimsy report in which FDA had clearly stacked the deck and by the way, we know this from a Freedom of Information Act, request that a number of compounder's funded. We have the emails that demonstrate everything that I've just said, FDA stacked the deck. And so now FDA is saying, well we're going to base future action on compounded hormones on this supposedly but not independent report. So APC takes seriously this threat. Our members serve millions of patients who benefit from compounded hormones. They work with hundreds and hundreds of prescribers who believe in compounded hormones and many of our members have patient outcomes that demonstrate the effectiveness in these therapies. And again, if you go to compounding.com, you can look up by state and see all manner of testimonials from patients who literally say this saved my life, it saved my marriage, in some instances people were contemplating suicide and through a prescriber who believed in compounded hormones and a compounding pharmacist, they were able to really get their lives back, as we say, to get back the joy of living. And so what we're finding is that while FDA has only issued an implicit threat to restrict right now, there's no formal action that they have taken. We think it is the time when we need to be making Congress aware of the number of their constituents who benefit from these therapies. They ought to hear these stories. They ought to understand that the nation report is not legitimate science. So that down the line, who knows when we think it could be coming within the next 12 to 18 months. If FDA makes a move to restrict compounded hormones, we have members of Congress and a Congress at large that is well versed on this issue. They understand what's at stake so that they can ask the hard questions and hold FDA accountable so that this is not just an FDA agenda. Whatever FDA does is rooted in science and clear patient outcomes. So that's where we are. We're in that education process and we need prescribers and patients to tell us their stories to reach out to their members of Congress and make sure they understand the implications of restrictions on these therapies. The fact is, there are not manufactured hormones that can meet the needs of every patient. They just don't come in the dosage form or the dosage strengths. We need compounded hormone therapy to fill that legitimate patient needs
JP: Absolutely. That's another one of the reasons I wanted to get you on here was because this is such a big deal and I know we have doctors come to us from time to time, you know, questioning it because they've heard through, you know some google searches or something about this going on. So if someone wants to help whether they be a provider or patient, what can they do to get involved?
SB: The simplest thing is what I've already mentioned. Please go to compounding.com, tell your story. Even if you're a prescriber, physician, nurse practitioner, PA tell us your story. Tell about patients who have benefited from these therapies and then take the time on the site to send a message to your member of the U. S. House of Representatives and your two U. S. Senators, making them aware of your concerns about these issues. We have template messages on the site that they can people can customize as they wish and send them to their members of Congress. So that's important. I would urge particularly practitioners those who prescribe these medications, the those who work with patients of compounded hormones to join this campaign and by joining this campaign, support it financially on compounding.com, you see there's a place on there where you can give to the campaign. We raised in late 2020 and through about July of this year we raised $1.5 million dollars to fund this campaign, build the website, digital media, et cetera, because we wanted patients and members of Congress to understand what was at stake. That's all in place for it to continue, In 2022, we are this week launching an additional fundraising campaign where we'll be raising 850,000 to continue the campaign for 2022. Our plans include enhancements to compounding.com. We want to do a better job of reaching prescribers that $1.5 million dollars that I just mentioned largely came from pharmacy compounders, and by that I mean largely pharmacists and pharmacy owners, there's some vendors in there as well, but we have not gotten much traction with the prescriber community, and I think that's because we haven't yet been able to reach them with the story with what's at stake here. So, telling your story, sharing it with members of Congress and then giving to the campaign, are the three things that I think are most useful.
JP: Absolutely, well, I really appreciate you being here. Is there anything additional you would like to add?
SB: If you are a pharmacy compounder and by that, I mean a pharmacist or technician, but I also mean a supply chain professional or someone who benefits from pharmacy compounding a prescriber, a patient. We would love to have you be a part of this alliance, you can go to our website at a4pc.org, there's a join tab click on that you'll see our different membership types and we would love to have you be a part of the alliance. Our voice is stronger when your voices are added to ours.
JP: Absolutely. Well, thank you so much for joining me. I really appreciate what you all are doing. I think it's huge for this industry and for compounders across the country, we need people and advocates like you to keep on continuing to do what we do. So, thank you again. For more information on Alliance For Pharmacy Compounding, like he said, please visit a4pc.org and thank you everyone for listening. Please make sure to subscribe and follow us on social media to stay up to date on Qualgen. Thank you again, Scott!
SB: Thank you.
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