Partnership for Safe Medicines releases action plan to protect patients from unapproved compounded GLP-1s

Today, emboldened by a lack of regulatory enforcement, telehealth companies and compounding entities are producing and marketing large volumes of unapproved compounded medications. These deceptively advertised compounded drugs carry significant risks for patients because they exist outside of the FDA’s rigorous review and approval system and they raise concerns about transparency and informed decision-making. PSM’s new report is a call to action for stricter enforcement of compounding violations, foreign imports and deceptive marketing and the development and implementation of new laws and policies that will help keep patients safe.

"The availability of unauthorized GLP-1 medications risks the safety of millions of Americans who do not recognize the dangers of these drugs,” PSM Executive Director Shabbir Imber Safdar said. “From dosing errors to quality and sterility concerns, too many Americans have already suffered at the hands of an industry that continues to put profits ahead of people’s well-being. We’re pleased to share this report as a guide for policymakers to uphold America's safety standards, empower the FDA to hold bad actors to account, and protect patients from substandard and dangerous medications.”

PSM stands ready to work with partners, lawmakers, and agency leaders to build on initial steps taken this year and put the recommendations into action.