Panel seeks tighter painkiller controls
Hydrocodone drugs focus of reform fight
In a monumental pushback against America’s narcotic painkiller epidemic, a U.S. Food and Drug Administration advisory panel recommended Friday that stricter controls be placed on popular narcotic painkillers such as Vicodin.
The 19-10 vote will be used by the FDA to decide if drugs containing the opioid hydrocodone should have the same restrictions as morphine and OxyContin, which contains oxycodone.
Ever since coming on the market 40 years ago, hydrocodone drugs have had fewer restrictions. However, as overdose deaths and addiction rates soared over the past decade, hydrocodone has been at the center of a fight to reform the use of opioids and deal with America’s epidemic of painkiller abuse.
The vote recommends that hydrocodone products be moved from the more relaxed controls of Schedule III to Schedule II under the Controlled Substances Act.
Stricter Schedule II status means that fewer prescriptions can be written at one time. For each visit to the doctor, a patient can get up to six months of prescriptions of Schedule III opioids such as Vicodin, compared with up to a maximum of three months for Schedule II drugs.
Schedule II drugs also have stricter handling and storage requirements.
For years, the FDA has balked at stricter controls on hydrocodone, saying that doing so could limit patients’ access to pain medicine.
But the U.S. Drug Enforcement Administration has again asked the FDA to consider tightening prescribing and other rules on hydrocodone drugs.
Andrew Kolodny, a New York addiction specialist who has pushed to curtail the use of opioids, said the vote marks a turning point in the epidemic and will lead to less people getting addicted to opioids.
Kolodny, a psychiatrist and head of Physicians for Responsible Opioid Prescribing, said people get addicted to the drugs in two ways.
Either they obtain them illicitly, such as stealing leftover pills from a medicine cabinet, or they are prescribed the drugs legitimately for a chronic pain condition by doctors who mean well.
“Doctors have had a false sense of security (about prescribing the drugs),” said Kolodny, chairman of psychiatry at Maimonides Medical Center in Brooklyn. “This is a clear message that hydrocodone is addictive.”
It was not known when the FDA would make a final decision on the issue.
The next step in the process is for the FDA and the National Institutes of Health to make a recommendation to the assistant secretary for health, who will make a final recommendation to the DEA.