The Human Values Behind Drug Compounding
Anne Comcowich
The high cost of medicine affords wealthier people a better opportunity for health than others. The recent “trend” of using Ozempic and other GLP-1 medications for weight loss highlighted this disparity. To prevent increasing costs, should pharmacies and physicians be allowed to compound ingredients of patented drugs owned by pharmaceutical companies even when there is no drug shortage?
Ozempic is used to treat Type 2 Diabetes. Without insurance, the brand-name drug costs between $1,000 to $1,200 on average per month. In 2022, demand for GLP-1 drugs increased for its weight-loss benefits, which caused a shortage. The FDA allowed pharmacies to compound drugs with the same active ingredients as the drugs in shortage, which lowered costs and met the demand. Compounding infringes on patent rights, but it is permitted only during shortages. On February 21, 2025, the FDA declared that the supply of approved, brand-name GLP-1 drugs met demand, which will bar compounding in the near future. The end of the shortage means that without compounding, pharmacies cannot make similar drugs at a lower cost. The price of GLP-1 drugs could increase and be financially unavailable to people who either need them to treat diabetes or want to use them for weight loss.
We can gain some useful insight into this question from a very different area of law: trespass to real property. In State of New Jersey v. Shack, an attorney and a nonprofit employee wanted to visit a migrant farm worker on an owner’s farm to remove the migrant worker’s sutures. The owner filed a complaint for trespassing against the attorney and nonprofit employee. The court held that the attorney and nonprofit employee did not trespass because the owner could not deny the migrant worker his privacy or interfere with his opportunity to live with dignity. The court reasoned that “property rights serve human values.” Human well-being therefore must be the predominant concern the law. Congress recognized this by passing Title III-B of the Economic Opportunity Act, which sought “to further the cause of justice among persons living in poverty” by mobilizing assistance of lawyers and other appropriate services. The court continued by stating that the goals of this law would not be met if the intended beneficiaries, migrant workers, could be insulated by the owner from efforts of assistance to reach them. Given the “competing needs of the parties, in light of the realities of the relationship between the migrant worker and the housing facility,” the court held that attorney and nonprofit employee could enter the owner’s farm without trespassing.
An examination of the doctrine of trespass under Shack provides insight into whether compounding outside of shortages should be allowed. Trespass is unauthorized entry into the property of another. The patients who need medications are like the migrant workers because they both have a right to live with dignity. Pharmacies and physicians are like the attorney and nonprofit employee who sought to help the migrant worker. The pharmaceutical companies are like the landowner who owns the property right. The companies could argue that they have an interest in enforcing the property right in their patent from intrusion by others because they created the drug formula. GLP-1 drugs are popular, so pharmaceutical companies would have less incentive to create innovative and life changing medication if they give up their rights to exclusively use their formula. Pharmacies and physicians could argue that they have a responsibility to dispense and prescribe medication to benefit patients. They have an interest in being able to serve patients by compounding medications that will best suit patient needs.
Although obviously patent law rather than real property trespass would directly apply here, the pharmacists’ arguments above offer powerful insights. Their “trespass” in using ingredients in a similar way as the pharmaceutical company to compound medication like brand-name GLP-1s serves a vital public policy interest. As the court in Shack said, property rights serve human values. Access to medicine is one of those human values. Ensuring that the actual drug formula remains protected would continue to incentivize pharmaceutical companies to innovate. Allowing pharmacies and physicians to continue compounding would best serve the public interest in keeping drug costs low and accessible. Keeping drug costs low also prevents the public from falling victim to counterfeit medication, which people buy often out of desperation due to the costs of branded drugs. Overall, continued compounding balances the interest of the pharmaceutical company with the health and wellbeing of the public. Policies that ensure that pharmacies and physicians can continue to compound drugs even when there is not a shortage of medication are worth considering.
Anne Comcowich is a student at the American University Washington College of Law.
Image: VariousPills.
