The FDA’s recent decision to approve the drug Zohydro™ Extended Release, a drug that has no abuse-deterrent features, suggests that the administration has been hypocritical of their goal to lessen the likelihood that people will abuse new painkillers.
According to the FDA, making painkillers less likely to be abused is a public health priority, but their recent decision to approve Zohydro has some healthcare officials asking where the FDA’s true intentions lie.
Dr. Charles Argoff, Professor of Neurology at Albany Medical College and Director of the Comprehensive Pain Management Center at Albany Medical Center, recently brought this subject to light in a video discussion. In the video, Argoff explained how an advisory panel voted 11 to 2 against approving Zohydro in December of 2012, citing concerns that it would be abused.
Just 10 months later, the FDA reversed their stance, making Zohydro the first FDA-approved, single-entity extended release hydrocodone product on the market. Zohydro’s approval led Argoff to ask:
“How practical and reasonable is it….to say that we have met with the current approval process, and the Zohydro does not present any greater risk than those that are currently on the market, when in fact what we are trying to do going forward is reduce the risk.”
Argoff went on to say that while the drug would have many benefits for patients dealing with chronic pain, its likelihood of abuse is high, as it is categorized as a schedule II drug with no abuse-deterrent features. He believes the FDA is trying to cover its track by announcing that the manufacturers of Zohydro have entered into an agreement with an outside agency to develop an abuse-deterrent formulation, but it’s unclear how long the process will take.
Argoff likened the FDA’s approval of a drug without abuse-deterrent features to manufacturing a car without airbags.
“Let’s think about this as we go forward,” said Argoff. “Yes, a new medicine has been approved, but is it the medicine that you will be willing to prescribe?”
Dr. Silverman comments
I couldn’t agree more with Dr. Argoff. This is ridiculously schizophrenic behavior by the FDA. To approve such a drug makes me wonder where their true motives lie.
The FDA is supposed to protect the public. This is not consistent with its mission and therefore other factors are at play. These poor decisions will have far reaching side effects and consequences. Death from a hydrocodone overdose will be the ultimate price to pay.
I know there is no way I will prescribe this new pill.
Related source: Medscape
