Healthcare / Politics

The Pains of the FDA: Agency Under Scrutiny for Approving Prescription Painkiller

Established in 1906, the Food and Drug Administration’s job is to ensure the protection and promotion of public health.  The FDA’s heavily invested power over product regulation comes with an even greater responsibility to safely serve the public.  The FDA is under fire for underplaying that responsibility by approving the painkiller Zohydro, which is a pill containing the highly addictive hydrocodone.

The FDA’s incorrect approval of Zohydro comes during a time when prescription drugs containing addictive opioids is the deadliest drug problem in America.  On average, 46 people a day die from painkiller overdoses, and 1,150 more land in emergency rooms.  Deaths from illegal drugs do not even compare to these numbers from prescribed drugs. One reason for these high numbers is the excessive rate of doctors’ prescriptions while drug companies turn a blind eye to claim profit. 

In 2013 alone, doctors wrote about 180 million prescriptions for hydrocodone and oxycodone This number equates to nearly one prescription for every adult in the United States.  With doctors liberally prescribing medications, the FDA regulation needs to be the roadblock that decelerates drug abuse.

For a brief moment in time, the FDA was up to the task of fighting opioid drug abuse in the US through stricter enforcement.  Last October, the FDA recommended stronger restrictions on access to drugs containing hydrocodone.  They planned to enforce restrictions through more frequent visits to doctors to obtain prescriptions and limits on refills.  However, just one day after proposing these changes the FDA approved Zohydro.  The FDA took one small step forward and one huge step backward.

The fury over the FDA’s approval of Zohydro stems from the drug’s highly addictive component.  The FDA initially approved Zohydro because it contains no acetaminophen, which can cause liver damage.  Opponents of the drug argue that this same component makes the drug even more powerful and more likely to be abused.  The pill also does not have the abuse-deterring measures common in most narcotic painkillers such as hardened shells that make them difficult to crush.  In capsule form, Zohydro can easily be crushed and injected or snorted by abusers. The drug also comes in doses packing five to ten times more heroin-like narcotic than other common hydrocodone products. 

This increases the likelihood of prescription drug abuse so much that the FDA’s own expert panel voted 11-2 against Zohydro approval. Attorney general’s in 28 states, members of Congress, and at least two governors have criticized the FDA’s approval of Zohydro.  Some states, such as Massachusetts, tried to ban sales; but a court threw out the case. 

Critics should keep pressuring the FDA to reconsider its approval of Zohydro.  The FDA should also encourage other approaches to minimizing painkiller abuse, as well.  Painkiller abuse is a serious public health crisis. The FDA should be a part of the solution and not part of the problem by approving dangerously addictive drugs.