Senator Joe Manchin of West Virginia has introduced a bill that would reverse the FDA’s approval of Zohydro ER until its maker develops a version with less potential for abuse.
Zohydro ER is an opiate painkiller developed by the pharmaceutical company Zogenix. Zohydro is comprised almost entirely of hydrocodone. Critics of the drug claim the drug should never have been approved by the FDA in the first place, because it does not have anti-abuse technology (such as a crush-proof pill casing to prevent bypass of the time-release function).
Two similar bills were introduced in the House of Representatives on the same day, but the FDA continues to defend its approval of Zohydro.
“The FDA has not had an opportunity to review the proposed legislation,” FDA Commissioner Margaret Hamburg told Medscape. “However, the agency looks forward to continuing to work with Congress on preserving access to medications for patients suffering from pain, while addressing a serious public health problem — the inappropriate use of opioids. These are important and complex issues, which will benefit from full and thoughtful discussion.”
A new formula for Zohydro ER with qualities that will deter abuse is reportedly in development, but will take at least a year.
Zohydro ER went on sale in March after the FDA approved it in October.