FDA Approves Generic Version of OxyContin

FDA on Tuesday approved the first generic versions of OxyContin, which are expected to "significantly lower" the cost of the medication from "hundreds of dollars a month," the AP/Boston Globe reports (AP/Boston Globe, 3/23). As part of the approval, Teva Pharmaceuticals and Endo Pharmaceuticals, the two approved generic drug makers, must establish risk-management plans to prevent the abuse and illegal sale of the medication consistent with those currently in place by Purdue Pharma, the maker of brand-name OxyContin, the Wall Street Journal reports (Mathews/Abboud, Wall Street Journal, 3/24). OxyContin bears FDA's strongest warning label, which explains that the drug potentially is as addictive as morphine (AP/Boston Globe, 3/23). According to the Journal, law enforcement officials have "long been concerned" about what effect cheaper and "less well-controlled" versions of OxyContin could have on prescription drug abuse (Wall Street Journal, 3/24). The approval comes weeks after the Bush administration announced a comprehensive campaign to increase efforts to curtail prescription drug abuse. A report released in early March by the White House Office of National Drug Control Policy found that 6.2 million U.S. residents abused prescription drugs in 2002. As part of the $12.6 billion effort to reduce prescription drug abuse by 10% in two years and by 25% in five years, the campaign will increase federal spending, develop prescription monitoring programs in more states, use technology to identify and prosecute operators of illegal prescription Web sites and discourage credit card companies from facilitating sales (California Healthline, 3/2). However, Peter Pitts, FDA's associate commissioner for external relations, said the agency did not believe that the introduction of generic versions of OxyContin would increase demand for the medication, based on past generic introductions (Wall Street Journal, 3/24). Agency officials said they were "seeking to balance effective pain management for more than 10 million Americans who suffer chronic pain with a minimized potential for abuse," according to the AP/Globe (AP/Boston Globe, 3/23). A Purdue spokesperson said that "flooding the market" with generic versions of OxyContin without the same abuse-prevention programs currently in place "seems ... like asking for trouble," the Journal reports. Both generic companies are still in a legal dispute with Pharma, and it is not clear when the drugs will go on the market, or how they will be priced (Wall Street Journal, 3/24).