Plan serves as policy roadmap to strengthen America’s gold standard patient safety system
The Partnership for Safe Medicines today published a report outlining solutions to protect patients from the risks of a growing compounded GLP-1 marketplace. A Call to Action: Restoring and Strengthening America’s Patient Safety System serves as a detailed plan for policymakers and regulators to uphold the gold standard system that protects Americans from untested and unsafe medicines.
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 knockoffs 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 pursue commercial interests at the expense of unsuspecting patients. We’re pleased to share this action plan 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 invites partners, lawmakers, and agency leaders to join them in building on initial steps taken this year and putting the recommendations into action.
About the Partnership for Safe Medicines
The Partnership for Safe Medicines (PSM) is a public health group comprised of non-profit organizations that handle medicine from the factory floor to the patient and are committed to the safety of prescription drugs. To learn more, visit www.safemedicines.org.
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