Science.
Safety.
Standards.
“American patients trust that the medicines they receive meet the highest safety and quality standards. Protecting that trust means ensuring clear standards, transparency, and strong oversight across the pharmaceutical supply chain.”
Protecting the Integrity of America’s Medicines
Mass-compounded products — sold without U.S. Food and Drug Administration (FDA) review, made with unverified ingredients, and marketed with misleading claims — and counterfeit drugs pose a growing threat to patient safety. Rigorous safeguards, clear accountability, and meaningful oversight are essential to protecting patients and preserving trust in the U.S. medicine system.
ASEM’s approach to strengthening medicine safety and integrity revolves around three core tenets:
Combating Counterfeit Drugs and Illegal Mass Compounding
Mass compounders and bad actors operating outside federal law, and the platforms distributing their products, need stronger enforcement.
Strengthening the Integrity of the U.S. Pharmaceutical Supply Chain to Fight Counterfeit Drugs
Ingredient sourcing, supplier vetting, and manufacturing standards should apply equally to every product reaching patients.
Holding Mass Compounders and Platforms Accountable
Patients deserve transparency from the companies making, marketing, and distributing products that claim to be medicine.