The FDA’s risky action on compounding weight loss drugs The agency may be setting a precedent that could undermine its public health obligations

https://www.statnews.com/2024/11/19/fda-glp-1s-weight-loss-drugs-zepbound-wegovy-compounding-law/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz--dtnFjXFHSUusDzBP5YxsYcX8XylbLP1AwsZp13TVWvUUvJbx0sJTLWBqgs8NItbfIEBHDsqVbrTknayFmSvq7uixf0Q&_hsmi=334535734&utm_content=334535734&utm_source=hs_email Opinion: The FDA's risky stance on GLP-1 compounding The FDA is foregoing its public health obligations by allowing pharmacists to compound GLP-1 medications as an alternative to brand-name drugs like Wegovy or Ozempic, Scott Gottlieb, the agency’s former commissioner, writes in a new First Opinion for STAT. In many cases, GLP-1 drugs are being compounded in pharmacies that do not meet the FDA’s highest manufacturing safety standards, Gottlieb argues. And while the agency initially cited shortages in certain GLP medications as a reason it was allowing compounding to continue, those shortages have largely resolved. The FDA was never intended to use its discretion on compounding enforcement as a means of helping to lower drug prices, Gottlieb argues, and doing so could set a precedent that leaves the agency vulnerable to outside political pressure.