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OAC and Our Support of Legislation on Compounding
by Joe Nadglowski
Why does OAC engage so actively in discussions about compounded medications?
It might be easier for OAC to stay quiet on compounding. We could choose not to engage. But we believe silence would be irresponsible and that individuals affected by obesity need to know more about what is going on behind the scenes of the compounding industry and what we are hearing.
Our involvement is driven by patient safety.
We are deeply concerned that people living with obesity are being forced, out of desperation, toward potentially unsafe or unapproved medications. No one should have to make that choice.
But we recognize many of our members, family and friends are forced to make that choice every day and as such, it is important to note, OAC is fighting the other side of this battle just as aggressively. Policymakers, pharmaceutical manufacturers and health insurers must act with urgency to reduce the pressure that denies those of us living with obesity high quality care. Everyone has a responsibility to ensure people living with obesity have affordable access to safe, effective, FDA-approved treatments. OAC is fully committed to achieving this goal, and we will spare no effort in pushing for systemic change and will continue to do so until every patient who wants and needs care has access to it.
Compounding has a role but safety must come first.
We believe compounding does have a role in obesity care as we work toward a system where everyone who needs care can access it; however, recognizing a role for compounding does not mean giving compounders a pass.
Just as OAC has challenged the pharmaceutical industry on pricing, access and innovation, we must also challenge compounders to meet higher standards for quality and safety. Patient safety cannot be optional, and accountability must apply to everyone involved in obesity care
Recent legislation on compounding:
You may have seen headlines or social media posts about new bipartisan legislation from Representatives Yakym and Carson focused on pharmacy compounding.
OAC wants to be very clear: our support for this legislation is not about ending GLP-1 compounding. We believe compounding is part of the current care landscape. As long as people are relying on compounded products because affordable coverage is not the norm, those products must be produced with safeguards protecting patients and not all compounders are using safe practices.
What we need legislation on compounding to do:
- Establish a clear and enforceable playing field.
Current compounding law suffers from gaps in regulation and enforcement. Too often, compounding feels like the “Wild West,” a situation that is worsening as more gray-market products enter the mainstream, including peptide-based operations. Read more about the gray market here.
Some compounding pharmacies are following the rules and have safeguards in place, while others are willing to skirt the rules. If a compounder is willing to bend the rules around when and how they can produce a product, it raises concerning questions about whether they are also willing to cut corners on safety and quality.
The Yakym–Carson bill attempts to address this by setting clearer definitions, particularly around “essentially a copy.” The definition may not be perfect, and reasonable people can debate where the line should be drawn. But there is no doubt that we need a line, and right now that line is unclear.
- Track the volume and distribution of compounded medications.
Media reports suggest that millions of people may be using compounded GLP-1s, yet we do not know how many people are using them or where those medications are distributed. This also means that there is no way to let people know if there is something wrong with their medication. That lack of information is simply not acceptable.
In fact, compounders told OAC they are willing to report distribution data. The Yakym–Carson bill takes an important first step by requiring reporting of out-of-state distribution (recognizing that federal authority over purely in-state activity is limited). You cannot track safety or respond effectively to harm, if you don’t know who is using these medications and from where they are coming.
- Require basic safety inspections.
If a facility is producing hundreds, thousands, or more doses of medication, regular safety inspections must be required. This is common sense.
Compounders have told OAC they welcome inspections, which is why they should support this aspect of the Yakym–Carson bill. The legislation would require regular FDA inspections of 503B outsourcing facilities, helping ensure that large-scale compounding operations meet basic safety expectations.
What measures would ease OAC’s stance on compounding?
OAC is often asked, “What would make you more comfortable with compounding?” Measures like those outlined above are a strong beginning.
We put patient safety first. I’ve said before that there are “good” compounders and “bad” compounders, but as a patient organization, we have no reliable way to tell them apart. That uncertainty puts patients at risk, and we want to do everything we can to minimize any risk.
It’s time for responsible compounders to step up and support reasonable oversight so patients and providers can have confidence in safety and quality. We also urge legitimate compounders to take a stronger stand against the gray market, which undermines trust and threatens patient safety.
To those who support or rely on compounded medications:
OAC recognizes that compounding is likely here to stay in some form within obesity care. That reality makes safety even more important.
As prices for obesity medications continue to decline, more treatments receive FDA approval, and insurance coverage expands, we must strengthen efforts to establish obesity care as a standard health benefit. Now is the time to move away from a two-tiered system and demand affordable, high-quality, mainstream care for all people living with obesity.
Our goal is simple: ensure people living with obesity have access to safe, comprehensive care – everyone would prefer to use an FDA-approved medication if affordable coverage were available. OAC will continue fighting to change the system and expand access to evidence-based obesity care.
OAC supports this legislation because it begins a necessary conversation about safeguards for people living with obesity, because safety should never be optional.