Published
May 30, 2025
The big picture: In the biopharmaceutical industry, innovation is not just a buzzword—it’s the lifeblood of progress. Companies invest billions in research, development, and regulatory compliance to bring safe, effective therapies to market. Robust IP rights allow biopharmaceutical innovators a time-limited opportunity to be rewarded for their breakthroughs and incentivized to continue pushing the boundaries of science for new cures and treatments.
Driving the news: Life science innovators develop advanced medicines in the pursuit of a healthier world, and in recent years no new medicines have changed the game more than GLP-1s. When prescribed safely and accurately by a medical professional, GLP-1s are shown to help patients manage their diabetes and lose weight. Given the effectiveness of these medicines, their popularity and demand has skyrocketed in recent years. At one point, the U.S. Food and Drug Administration (FDA) declared a temporary shortage of GLP-1s, which allowed other companies – known as compounding pharmacies – the opportunity to produce and sell a different, compounded version of GLP-1s. Now, with the shortage over, the FDA directed compounding pharmacies to cease GLP-1 productions and sales on May 22, 2025.
Understanding compounding: Compounding pharmacies are licensed facilities that create customized medications tailored to the unique needs of individual patients when commercially available drugs may not be suitable – such as in cases of allergies, personal dosage needs, or other medical reasons. When operating legally, these pharmacies follow strict guidelines set by the FDA and state pharmacy boards, using approved ingredients and maintaining high quality standards.
However, problems arise when compounding is misused. The growing demand for GLP-1s both in the U.S. and globally has led some companies to cut corners, creating a dangerous and uneven playing field. When compounding pharmacies use low-quality ingredients and bypass important safety protocols to take advantage of temporary drug shortages, they put patients at risk and undermine the work of legitimate biopharmaceutical innovators and those compounders that follow the rules. This damages public trust in the safety of medications and discourages investment in new treatments, ultimately diminishing patient outcomes.
The solution is clear: Regulators must enforce existing laws with vigilance, and policymakers must continue to advocate for strong IP protections. Supporting IP rightsholders isn’t just about defending patents—it’s about ensuring that medicines are safe and effective. In a world where scientific advancement is more important than ever, we must ensure that those who innovate are protected—and that those who compromise safety and integrity are held accountable.
About the author
Sydney Redden
Sydney Redden is Director of IP Enforcement for the U.S. Chamber of Commerce's Global Innovation Policy Center (GIPC).
