Niagara Gazette

January 31, 2013

Schumer tells FDA to restrict drug

Niagara Gazette

Niagara Gazette — The U.S. Food and Drug Administration should make hydrocodone a schedule ll drug, which would increase restrictions on the painkiller, U.S. Sen. Charles Schumer, D-New York, said Wednesday.

With prescription drug abuse on the rise, the time is now to increase control and restrictions on the widely-prescribed painkiller, Schumer said. According to the Upstate Poison Control Center, in 2011 there were 2,335 such cases of hyrdocodone abuse in Western New York. There was a reported 429 cases in Niagara County during that time.

Schumer wants the FDA to approve the recommendations of the Drug Safety and Risk Management Advisory Committee, a group of doctors and scientists who say hydrocodone should be reclassified as a schedule II controlled substance, up from its current standing as a schedule III drug.

But, the new restrictions must not hamper those who actually need hydrocodone, Schumer said.

“The federal government must do everything in its power to restrict the use of hydrocodone to those patients who actually need it and I’m urging the Food and Drug Administration to support its drug safety panel’s recommendation to reclassify hydrocodone as a Schedule II drug, to help end this scourge that has caused our country to see more overdose deaths from this drug than seen with heroin and cocaine combined,” Schumer said. “Stricter federal rules must be put in place regarding the regularity and quantity with which we prescribe these painkillers, so that our children, parents, spouses and friends don’t continue to fall prey to them each day.”

The stricter regulations would make it harder to access painkillers that contain hydrocodone and limit access to high-level refills of such drugs over short periods of time.

On Jan. 25, the Drug Safety and Risk Management Advisory Committee issued a recommendation to increase hydrocodone’s classification by a vote of 19-10. Schedule II substances have a high potential for abuse, which may lead to severe psychological or physical dependence.

Schedule II drugs include narcotics like oxycodone and morphine, as well as stimulants like methamphetamine and amphetamine. 

Once the FDA approves the change, the final step is approval from the U.S. Department of Health and Human Services. Schumer said the department has already said it would back the committee’s recommendation.

At that point, greater restrictions would be implemented in how doctors can prescribe hydrocodone, the quantity that can be prescribed and the ways it can be stored in doctor’s offices. Schumer noted that while New York state considers hydrocodone a schedule II narcotic, a federal law is critical to ensure that abusers or dealers cannot easily obtain the drug from neighboring states.

”To have a real effect, there must be a law at the national level,” Schumer said.

Schedule II controlled substances require a written or electronic prescription which must be signed by the practitioner. The refilling of a prescription for a controlled substance listed in schedule II is prohibited, therefore a new prescription must be issued each time a patient needs a refill.

In a letter to the FDA, Schumer said 47 million American patients were given prescriptions for hydrocodone in 2011. According to an October 2012 study using data from the National Survey on Drug Use and Health, the rate of prescription painkiller abuse among American youth is 40 percent higher than in previous generations. The study also found a more than 500 percent increase in the number of people seeking treatment for addiction to prescription opioids between 1997 and 2007.

According to Center for Disease Control, for example, prescription drugs were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined.