The FDA Must Restrict the Use of Prescription Narcotic Hydrocodone

In recent testimony before a Food and Drug Administration (FDA) advisory committee, West Virginia Sen. Joe Manchin spoke in troubling terms about the ease of access to a specific dangerous narcotic, stating: “For underage children, these drugs are easier to get than beer or cigarettes.”

Manchin was not referring to illegal “street” drugs, but rather to the prescription narcotic hydrocodone, which together with oxycodone (OXYCONTIN) has been described in his state as “hillbilly heroin.” West Virginia is by no means alone in experiencing overuse of the addictive drug. In fact, the U.S. as a whole is, by far, the narcotics-prescribing leader in the world, in terms of doses of narcotics per million patients, with hydrocodone being our most prescribed drug of any kind. Ninety-nine percent of the hydrocodone in the world is both manufactured and used in this country, attesting to the fact that the drug is overprescribed here and should be severely restricted.

With more than 131 million U.S. prescriptions a year, mostly for generics, hydrocodone is always used in combination with other painkillers, such as acetaminophen, the ingredient in TYLENOL. Domestically, hydrocodone is available with multiple refills, a prime reason for the massive use and abuse here. In other countries, equally effective narcotics (including hydrocodone, where available) are better regulated than in the U.S.

Public Citizen testified in the same January 2013 hearing at which Sen. Manchin spoke. Our testimony at the hearing supported increased regulatory control by moving hydrocodone out of the dangerously loosely regulated Narcotics Schedule III, reclassifying it as Schedule II. We pointed out that the total defined daily dose (a statistical measure of drug consumption) of hydrocodone consumption for a year for the entire U.S. population is 2.8 billion doses, which translates to almost 8 doses per person per year.

We also asked this question: Is it too much of a burden for doctors to see patients with cancer pain or severe noncancer pain at least once every three months, as would be the case for those seeking refills to hydrocodone under the Schedule II designation that we support?

If the answer is yes, it is likely that the pain patient is not receiving adequate medical care. If the answer is no, the provisions of Schedule II will greatly facilitate this process, allowing a visit once every three months without any of the predictably less-controlled refills and other dangerously lax Drug Enforcement Administration regulations now in place for Schedule III drugs.

Some small increase in oxycodone prescriptions may result from the rescheduling, but the large reduction in hydrocodone prescriptions will outweigh this risk. In decreased hydrocodone use, the U.S. will move toward, rather than contrast with, the view of most of the world that hydrocodone is not “essential” for treatment of pain. Mandating a more thoughtful process to prescribe this powerful narcotic will reduce inappropriate prescribing for those with moderate noncancer pain.

Ultimately, the FDA advisory committee’s vote was a clear 19 to 10 in favor of reclassifying hydrocodone as Schedule II. We hope that the FDA, previously opposed to the rescheduling, agrees with this strong message. Panel member Dr. Maria Suarez-Almazor, a professor of internal medicine at The University of Texas MD Anderson Cancer Center, voted for the rescheduling, stating: “I’m appalled to see that hydrocodone is the most prescribed drug in the U.S., and [there] has to be something very wrong with our health-care system and society for this to happen.”