FDA Approves Generic OxyContin
FDA approved two generic versions of oxycodone hydrochloride extended-release tablets—a Schedule II controlled substance—on March 23, but only after the makers of the potent painkillers agreed to have risk management programs in place before marketing the products to minimize their abuse, misuse, and diversion.
The risk management plans developed by the generic makers, Endo Pharmaceuticals and Teva Pharmaceutical Industries, must be consistent with one used by Purdue Pharma, maker of the brand-name version of the product, OxyContin, said Robert J. Meyer, who oversees FDA's division of anesthetic, critical care, and addiction drug products at the Center for Drug Evaluation and Research.
Purdue filed a petition this past January with FDA requesting risk management plans for all generic forms of OxyContin.
Endo was approved to market tablets in strengths of 10, 20, and 40 mg, and Teva was approved to market 80-mg tablets.
Purdue's product was approved in 1995. By 2001, OxyContin sales had exceeded $1 billion annually, and the drug had become the country's most frequently prescribed brand-name narcotic medication for treating moderate to severe pain, according to a recent report issued by the General Accounting Office (GAO).
Many state law-enforcement agencies began reporting in early 2000 a trend in abuse of the painkiller.
A black-box warning was added to the labeling of OxyContin in July 2001, stating that the tablets were to be swallowed whole and not broken, chewed, or crushed.
Abusers of the product generally crush the tablets and snort the powder or dissolve the tablets in water and inject the solution, according to the Justice Department's National Drug Intelligence Center. GAO reported that 146 Americans died from illicit OxyContin use in 2000 and 2001.
In fiscal years 2001 and 2002, GAO's report noted, the Drug Enforcement Administration initiated 257 OxyContin-related abuse and diversion cases, which resulted in 302 arrests and about $1 million in fines.
Purdue collaborated with FDA in devising a risk management program for OxyContin, which the company implemented in 2001, according to spokesperson James W. Heins.
Purdue also initiated education programs and other activities for physicians, pharmacists, and the public to address OxyContin abuse and diversion, he added.
But GAO scolded Purdue in its recent report, stating that although the drug company had used very specific information on physician prescribing practices to market and promote OxyContin since its approval, it was not until October 2002—seven years after approval—that Purdue began to use the data and other indicators to identify patterns of prescribing that could point to possible improper sales representative promotion or physician abuse and diversion of the painkiller.
GAO recommended that risk management plans for Schedule II controlled substances contain a strategy for monitoring and identifying potential abuse and diversion problems.
FDA's Anesthetic and Life Support Drugs Advisory Committee came to the same conclusion in September 2003, Meyer noted.
Even with risk management programs in place, however, it could be months before the generic versions of extended-release oxycodone tablets are available because of a patent infringement lawsuit filed by Purdue Pharma.
The U.S. District Court for the Southern District of New York ruled in January that, while Endo infringed on Purdue's patents, the patents were unenforceable because of "inequitable conduct" by Purdue. Purdue has filed an appeal, Heins said.
Bill Newbould, vice president of corporate communications for Endo, said his company has not decided yet whether to "launch the product at risk" before the appeals court rules on the case.