Sen. Joe Manchin (D-W.Va.) is urging the Department of Health and Human Services to overturn the Food and Drug Administration’s approval of extended-release hydrocodone bitartrate (Zohydro ER), calling the drug "a powerful and dangerous opioid drug product with a high potential for abuse."
In a March 10 letter to HHS Secretary Kathleen Sebelius, Sen. Manchin noted that the FDA approved the drug "despite strong opposition from its own Anesthetic and Analgesic Drug Products Advisory Committee."
The drug is expected to come on the market in March.
Sen. Joe Manchin
"Simply put, the FDA’s approval of Zohydro ER, in its current form, must be stopped before this dangerous drug is sold to the public," Sen. Manchin wrote. Zohydro ER "has up to 10 times as much hydrocodone as Vicodin and Lortab and will come in a formulation that can be easily crushed, snorted, and injected."
In his letter, Manchin raised questions about the drug’s approval. "I am deeply troubled that the reason for Zohydro ER’s approval may be linked to allegations that the FDA gave manufacturers of prescription drugs the opportunity to pay thousands of dollars for the privilege to attend private meetings with FDA officials," he wrote, citing news reports. "Allegations have been raised that a new, scientifically questionable methodology for drug approval was created at these pay-to-play meetings."
The FDA has denied any improprieties regarding those private meetings, which the agency has said were intended to help the FDA better evaluate evidence from clinical trials.
The senator’s letter follows similar efforts of 28 state attorneys general and 8 members of Congress. All voiced concern that the drug could lead to additional overdoses.
Zogenix, which makes the drug, notes the risks of "addiction, abuse, and misuse" in the labeling for hydrocodone bitartrate.