When Makena, a drug designed to prevent preterm births, hit the market in 2011 at $1,500 per dose, it drew rife backlash. The drug was based on an active ingredient that had been available for many years at a much lower cost. Confronted with the public outcry, the FDA took an unusual step: It allowed pharmacies to continue making their own copies of the drug through the practice of pharmacy compounding, selling it at a fraction of Makena’s price.

Compounding serves a vital role by enabling pharmacies to tailor medications to the specific needs of individual patients when commercially available drugs are insufficient — for example, mixing flavored elixirs for children, removing allergens for sensitive individuals, or creating alternative formulations such as turning pills into liquids or topical ointment.

The FDA had granted Makena approval under a policy meant to incentivize companies to run the costly trials needed to prove that older, unapproved drugs were safe and effective. Many of these older drugs had been grandfathered in when the new drug approval process was established in the 1960s, so they had never undergone clinical studies to secure FDA approval. By permitting compounders to compete with Makena rather than enforcing its exclusivity, the FDA sent a clear signal: The agency was opening the door to competition by compounding pharmacies as a rebuke to a branded drug’s steep price.

The episode echoes the current debate over the FDA’s permissive stance on the compounding of GLP-1 drugs used for weight loss. Initially, the agency cited shortages of semaglutide and tirzepatide — the active ingredients in the popular drugs Wegovy and Zepbound — and allowed pharmacies to compound these drugs under a provision for addressing drug shortages. In October, the FDA announced that the tirzepatide injection shortage had been resolved and removed it from the agency’s drug shortage list. The agency then quickly reversed itself and allowed compounding to continue, referencing the high cost of the branded drug in explaining its decision to the press. In doing so, the FDA risks setting a precedent that, like Makena, could undermine its broader public health obligations.

Pharmacy compounding offers essential medical options for certain patients, but the practice was never intended to provide price competition for branded drugs. That role falls principally to generic drugs, and to policies that ensure there is brisk competition once legitimate intellectual property protections have lapsed. The rules governing the modern regulation of compounders were enshrined in the Drug Quality and Security Act (DQSA), signed into law in 2013. The law was a response to the tragedy involving the New England Compounding Center, where contaminated compounded drugs caused a meningitis outbreak, killing more than 100 patients and sickening 800. Implementing the provisions of DQSA was one of the most challenging political tasks that I faced as FDA commissioner.

The FDA has long harbored safety concerns when drugs are compounded in bulk, particularly when they are distributed via mail or through doctors’ offices, where they might sit on a shelf for long periods. Under certain conditions, the law allows compounding pharmacies to qualify as “outsourcing facilities” by agreeing to meet the FDA’s standards for good manufacturing practices to ensure a drug’s quality and sterility. In exchange, these pharmacies can compound drugs for storage in doctors’ offices or later shipment to patients. Since the drugs from outsourcing facilities are produced under careful oversight to ensure their sterility, the risk of contamination while they are in storage is generally lower.

In many cases, however, the GLP-1 drugs are being compounded in pharmacies that are not required to meet these good manufacturing requirements. These are often smaller pharmacies that are permitted only to compound drugs for individual patients, with the expectation that the drugs will be used shortly after they are made. Yet they are compounding large volumes of drugs and shipping them across the country. Even in cases where outsourcing facilities produce these drugs, there are nagging questions about how pharmacies can obtain large volumes of the same active ingredients used in the brand drugs, raising concerns about the quality of compounded versions. Doctors often lack full knowledge of what these products contain, and patients can misunderstand what they are receiving, frequently assuming that compounded drugs are the same as brand alternatives.

The FDA’s efforts to implement the provisions of the DQSA were always politically charged. We faced persistent opposition from some members of Congress, who were concerned about the law’s economic impact on small pharmacies. Many of these pharmacies play a crucial role in rural communities, and for some, compounding drugs in bulk for use in doctors’ offices or distribution to patients is a major source of revenue. We took steps to reduce the financial burdens of the law, but implementing the core elements of the DQSA remained a high priority to ensure the safety of patients reliant on compounded medicines.

The DQSA was not in place during the Makena action, and the new law never intended that the FDA would weigh drug prices in allowing compounded medicines. High-quality manufactured drugs should not become products that only certain patients can afford, while others must rely on compounded drugs that are not made to the same standards.

If the FDA shows that its regulations can be selectively enforced to align with objectives on drug pricing, it is likely to face even more pressure to loosen its oversight of other compounded drugs. The precedent it set on Makena, and potentially now tirzepatide, could leave the agency hard-pressed to maintain control over these critical policies in the future.