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FDA drops plan that would reduce patient access to compounded drugs

WASHINGTON, D.C. – Following Republican and stakeholder opposition, the federal government dropped its plan that would have restricted patients’ access to lifesaving medications.

The Food and Drug Administration (FDA) announced today that it is rescinding a controversial memorandum of understanding (MOU) requiring states to either adopt a burdensome, poorly crafted policy targeting drug compounders or risk losing access statewide to vital medications.

Rep. Earl L. “Buddy” Carter (R-GA), a pharmacist by training and congressional advocate for modernizing FDA compounding rules, praised the announcement as a win for patients:

“I am pleased that the FDA listened to stakeholders, concerned citizens, and lawmakers,” said Carter. “The federal government has long targeted drug compounders with unfair and restrictive requirements that raise drug prices and reduce access without improving the industry for patients or workers.”

“As states are battling COVID-19, a spike in overdoses, and increasing mental health cases, now is not the time to impose new top-down regulations. If the drug compounding industry is going to improve, it will be done in concert with the private sector, not against it,” said Carter. 

Read the full letter detailing Republican concerns with the MOU here


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