Addressing Legal Battles in the Pharma Space

In a video interview with Pharma Commerce, Donald Prentiss, founder and CEO of Qualthera, describes how compounding pharmacies play a critical role in addressing unique and unmet medication needs that cannot be met by commercially available drugs. Their role in the pharmaceutical supply chain varies depending on the type of compounding facility: 503A or 503B.

A 503B facility, also known as an outsourcing facility, primarily supplies office-use medications to healthcare providers, who then administer them to patients. These facilities must adhere to current Good Manufacturing Practice (cGMP) standards, as they are FDA-registered and subject to inspections. In contrast, a 503A facility focuses on compounding medications based on individual prescriptions, typically in smaller, patient-specific batches. This allows for customization, such as removing allergens or adjusting dosage forms to better suit a patient's needs.

Both types of compounding pharmacies are particularly useful in cases of drug shortages or when commercially available drugs are insufficient. For example, if a patient requires a medication that is in short supply, a compounding pharmacy can step in to provide a tailored solution. This flexibility makes compounding pharmacies essential for meeting the unique needs of patients, whether by modifying an existing medication or creating entirely new formulations to address specific medical conditions.

Ultimately, the primary function of compounding pharmacies is to bridge gaps in the pharmaceutical market by providing personalized, alternative treatments that meet the diverse needs of patients.

Prentiss also comments on the tirzepatide shortage, the notion that commercialized and compounded drugs are competing with one another, what needs to be done amid the various legal battles pertaining to GLP-1s that are currently taking place, and much more.

A transcript of his conversation with PC can be found below.

PC: What do you believe needs to be done amid the various legal battles pertaining to GLP-1s that are currently taking place?

Prentiss: I totally sympathize with drug manufacturing. You spend all this money to get the patent, get your drug to market, and it's successful. Then, you run out and try to gear back up; you look around, and there's thousands of these facilities now making your drug and getting that revenue. They go through the process. They respect the FDA process to get these things approved, and so they want to protect their interests. They have stakeholders too, so I totally get that side. On the compounding side, as I alluded to before, there is a statutory framework that allows compounders to make these drugs in shortage, and if there's a medical need to alter that drug in some form or fashion. Both sides have the right to engage in these battles based on what's allowed from a regulatory perspective.

To answer your question, what brings it together goes back to collaboration. When the shortage happened with all these weight loss drugs, compounding arguably helped further the success of the drugs. They made it more widely available. More people started to use it, and saw the benefits of it, and so they kept that demand alive, arguably in the best interest of the Lillies of the world. How do you work together to say, thank you for helping us out, but now we want to transition back to our supply chain. We want to keep you in mind, so maybe we can come up with a preferred list of compounding pharmacies or outsourcing facilities that we can refer out to (contract outsourcing), but more collaboration there, so that we're not having to settle this in the courts and with the FDA.

I believe I saw it from the Ros, and the Hims, and the Hers of the world—they're largely used compounding pharmacies to supply their medications. What was really neat was that I think it was Ro who had some kind of agreement with Lily to channel their drugs to that platform now too, so that was a nice little kind of collaboration that I saw there. If these telehealth platforms can collaborate with drug manufacturers, and compounders having already collaborated with telehealth platforms, let's bring in the FDA. Let's bring in other stakeholders. Let's give the patients a voice. What do they want? A lot of these patients are paying cash for this stuff. That's how important it is for them to reach their healthcare goals, and and I think that's another kind of underlying thing here.

Even through COVID, we still saw demand for compounds. They're willing to pay cash even through economic downturns, because it was so powerful. Health is a great equalizer, as you know, and so without it, money is worthless, so I think collaboration is the key. The FDA does a good job of creating listening sessions and other conferences on the compounding side. They have a whole website dedicated to compounding excellence. A lot of useful materials on how to educate compounders on how to do things appropriately—getting that information from the industry. I think really pushing that, bringing in the trade groups like the OFA [Outsourcing Facilities Association], just to put our heads together to solve this together, instead of fighting each other across it.