FDA Panel Recommends Tighter Restrictions on Certain Painkiller Drugs
On Friday, an FDA advisory panel voted 19-10 to recommend that the agency strengthen restrictions on widely used painkillers containing hydrocodone in an effort to curb the increasing misuse of prescription drugs, theÂ New York TimesÂ reports (Tavernise,Â New York Times, 1/25).Â
According to the Drug Enforcement Agency, hydrocodone products consistently are the most-misused drugs in the U.S. The products typically are prescribed to treat pain from injuries, surgery, arthritis and other ailments (AP/Modern Healthcare, 1/25).Â
About the Recommendation
The panel -- which included scientists, pain physicians and other experts -- was convened by FDA in response to requests by DEA (New York Times, 1/25). In the past, FDA has rejected several DEA requests to reclassify hydrocodone products. However, advocates say FDA likely will adopt the panel's recommendation (Catan/Martin,Â Wall Street Journal, 1/25).
If FDA accepts the recommendation, drugs containing hydrocodone would be reclassified as Schedule II controlled substances -- the government's most restrictive category for pharmaceuticals -- placing it in the same category as other widely misused medications, such as OxyContin and fentanyl (Girion,Â Los Angeles Times, 1/25).
The change would limit the amount of pills physicians could prescribe at one time and would require patients to obtain a new prescription for refills. In addition, physicians would no longer be able to fax prescriptions or place orders over the phone.
According to theÂ New York Times, HHS would need to give final approval before the proposed changes could take effect (New York Times, 1/25).
Medical Professionals, Patient Advocates React to Recommendation
Medical professionals applauded the proposed change as an effective way to keep highly addictive drugs out of reach to those who might misuse them, theÂ New York TimesÂ reports.
Andrew Kolodny -- chair of psychiatry at Maimonides Medical Center in New York -- said, "This may be the single most important intervention undertaken at the federal level to bring the epidemic under control" (New York Times, 1/25).Â
Meanwhile, Sen. Joe Manchin (D-W.Va.), who proposed legislation last summer to increase controls of hydrocodone drugs, said if implemented, the changes would "help prevent these highly addictive drugs from getting into the wrong hands" (Wall Street Journal, 1/25).Â
However, during the panel's two-day hearing, some patient advocates voiced concerns that the proposed changes would add barriers for patients who need the drugs to manage chronic pain. Specifically, advocates for nursing home patients said the changes would require frail residents with chronic pain to make a trip to a doctor's office to receive prescriptions.Â
Panelists also warned that the proposed change could result in increased misuse of other drugs, such as heroin, the use of which has declined in recent years (New York Times, 1/25).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.