Legislators endorse FDA action against OxyContin generics


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They added, "We believe this decision will help protect patients while thwarting abuse. Our hope is that FDA builds upon this decision to promote patient safety and prevent further abuse of opioids.”

Rep. Upton and Sen. Coburn have sent letters to the FDA and its parent agency, the Department of Health and Human Services, since December, expressing their concern about the opiate and questioning the FDA's response to the threats of abuse it posed.

As it blocked the OxyContin generic on Tuesday, FDA Commissioner Margaret Hamburg wrote to the legislators to notify them of the decision to ban the early form of the drug. She wrote that the agency had determined that the "benefits of original OxyContin no longer outweigh the risks. Thus, the original formulation of OxyContin will be removed from the list of approved drugs" that the FDA regulates.

The FDA recalled the early OxyContin variety on Monday "for safety reasons," which assures that other companies will not be able to create a generic version of the medication.