Senate GOP: FDA-approved drug poses ‘significant danger’

Senate Republicans are pushing the U.S. Food and Drug Administration (FDA) to withdraw support for a prescription drug they say poses a “significant danger” to the public. 

The Food and Drug Administration approved Zohydro last October. But the move came less than a year after one of the FDA’s advisory panels warned against it because the painkiller contains high amounts of hydrocodone, a drug that government officials say is highly addictive and widely abused. 

{mosads}In a letter sent Wednesday, three Republican senators warned FDA Commissioner Margaret Hamburg that the agency’s approval of the painkiller could “undermine” congressional efforts to curb prescription drug abuse.

“This decision contradicts the FDA’s own advisory panel, and could undermine the important measures taken by the FDA, lawmakers, and state attorneys general to curb prescription drug abuse across the country,” wrote Senate Minority Leader Mitch McConnell (R-Ky.), Sen. Lamar Alexander (R-Tenn.), ranking member on the Health Committee, and Sen. Tom Coburn (R-Okla.).

Zohydro is the first FDA-approved drug that uses pure hydrocodone to treat chronic pain — as opposed to other combination drugs that mix hydrocodone with weaker, non-addictive painkillers such as aspirin to balance out the effects. 

Critics of the FDA’s decision say Zohydro could increase prescription drug overdose rates and lead to abuse and misuse of the painkiller. 

According to the Drug Enforcement Administration, hydrocodone is one of the most commonly abused medicines in the U.S. It is chemically similar to opium drugs like heroin and morphine.

The senators were outraged by the FDA’s decision. They asked Hamburg what safeguards the agency plans to implement to protect against abuse.

“We believe the approval of pure hydrocodone products without methods to prevent abuse, misuse, and diversion, including abuse-deterrent formulations, poses a significant danger to our constituents, as it could worsen the drug abuse epidemic in our country,” they wrote. 

Back in October when Zohydro was approved, a congressional Democrat said it was “outrageous” that the FDA did not include anti-abuse features that would have prevented people from crushing the pills in order to snort or inject them.

“FDA not only approves this dangerous drug, but does so without requiring any abuse-deterrent features,” Rep. Bill Keating (D-Mass.) said in a statement. “This is outrageous. Abuse-deterrent technologies should not be the anomaly, they must be the norm.”

Despite these concerns, Zohydro can only be prescribed by a doctor and cannot be refilled.