About Us
Mission
ASEM advocates to preserve quality standards for medicines through research, education, and common-sense policy.
Vision
We believe patients deserve a clear, evidence-based approach that puts them first and strengthens transparency and accountability in the U.S. pharmaceutical supply chain.
Who We Are
Fred H. Mills Jr., PharmD – ASEM Chief Policy Officer
Pharmacy Compounding & Regulatory Enforcement
“Unregulated mass-compounded products put patients at risk of illness or even death. That is not a patient failure; it is a transparency, accountability, and integrity failure. The infrastructure to protect patients exists. The tools to act are in regulators’ hands. We just need to enforce them and hold accountable violators of the system developed for patient safety.”
Why ASEM Matters: Americans expect medicines that have been tested for safety, quality, and efficacy. A new breed of mass compounders and telehealth companies are sidestepping safety standards, quality requirements, and accountability mechanisms that legitimate drug manufacturers are legally required to meet. It’s being done deliberately, at scale, and for profit to the detriment of unsuspecting patients.
Kathy Oubre, MS
“People living with cancer depend on safe, high-quality, and effective treatments. Counterfeit or illegally mass-compounded drugs don’t just jeopardize treatment outcomes — they expose patients to serious health risks and undermine trust that makes care possible.”
Why ASEM Matters: Cancer patients can’t afford to wonder whether their treatment is real. Counterfeiting of cancer drugs increased by 60% between 2021 and 2023, and cancer drugs were the fourth most falsified drug class worldwide in 2023.
Wayne Winegarden, PhD
“Illegal mass-compounded and counterfeit products threaten patient safety and undermine the innovation ecosystem by eroding trust, distorting markets, and weakening the incentives that support the research, development, and quality-controlled production of safe and effective treatments.”
Why ASEM Matters: Medical innovation can only deliver on its promise to improve patient outcomes when therapies are safe, effective, and trusted, making the fight against illegally mass-compounded and counterfeit products essential to protecting both patients and the integrity of innovation.
Richard O. Dolinar, MD
Endocrinology (Diabetes & Obesity Care)
“Treating diabetes and obesity requires confidence that every medicine will perform as expected. When illegally compounded products are marketed as equivalent to FDA-approved therapies, they erode the trust that is fundamental to patient care and make it harder for physicians and patients to make informed, evidence-based treatment decisions together.”
Why ASEM Matters: Illegal mass-compounded and counterfeit products introduce uncertainty where patients need confidence. Patients deserve medicines backed by the rigorous oversight, consistent quality, and accurate dosing that only FDA-approved therapies are designed to provide.