Brett Smith for redOrbit.com – Your Universe Online
On Thursday, the Food and Drug Administration (FDA) suggested tighter controls on how doctors prescribe common, widely-use narcotic painkillers containing the narcotic hydrocodone, making them controlled as strictly as powerful painkillers such as OxyContin.
In announcing its recommendations, the FDA said it had become “increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States.”
Janet Woodcock, who heads the FDA’s center for drug evaluation and research, said that the agency expects to submit its formal recommendation later this year that reclassify painkillers containing hydrocodone as “Schedule II” medications, an upgrade from their current “Schedule III” classification.
“We are announcing the agency’s intent to recommend to HHS (Health and Human Services) that hydrocodone combination products should be reclassified to a different and more restrictive schedule,” she said in a statement.
“This determination comes after a thorough and careful analysis of extensive scientific literature, review of hundreds of public comments on the issue and several public meetings, during which we received input from a wide range of stakeholders, including patients, health care providers, outside experts and other government entities.”
The change would come after the Drug Enforcement Administration (DEA) requested just such a move in 2009. According to federal data, doctors wrote over 130 million prescriptions for hydrocodone-containing drugs for about 47 million patients in 2011.
Created in a collaboration between the FDA and the DEA, the scheduling system ranks drugs according to their medical use, potential for abuse and international agreements, among other factors.
If hydrocodone-containing drugs were to become Schedule II substances, they would officially be considered having one of the highest potentials for abuse and addiction of all legally prescribed medications. Other Schedule II substances include morphine, the attention-deficit hyperactivity disorder (ADHD) medications Adderall and Ritalin and cocaine – when used as a topical anesthetic to treat cancer.
Prescription drugs are responsible for about 75 percent of all drug overdose deaths in the US. According to federal statistics, the number of deaths from prescription narcotic painkillers has quadrupled since 1999. With drugs containing hydrocodone representing about 70 percent of all opioid prescriptions, and their current status as a Schedule III substance, abuse has skyrocketed, experts have said.
In an interview with The New York Times, Woodcock said FDA officials have considered how the new rules might affect patients. However, she said that the effect on public health caused by the abuse of these drugs has created a watershed moment.
“These are very difficult trade-offs that our society has to make,” she said. “The reason we approve these drugs is for people in pain. But we can’t ignore the epidemic on the other side.”
The new regulations would cut the supply of the drug a person receives without a new prescription in half to 90 days. Under current regulation, a patient can refill a prescription for hydrocodone-containing drugs five times over a six-month period before needing a new prescription. Previous research has found that most patients use such medications for only 14 days.