Pfizer Inc. (PFE), Johnson & Johnson (JNJ) and Endo Pharmaceuticals Holdings Inc. (ENDP) will have to train doctors before they can give patients extended-release painkillers under a U.S. plan aimed at reducing prescription drug abuse.
Sixteen companies that make 25 pain patches and pills must create a program to teach medical professionals when these drugs should be used to combat pain and how to recognize signs that the treatments are being misused, the Food and Drug Administration said today. The Obama administration is urging Congress to mandate the training as part of licensing required by the Drug Enforcement Administration every three years.
The FDA began discussing in February 2009 how best to prevent deaths and side effects from overdose or tampering of long-acting painkillers to get high. While the agency has stopped short of restricting drug distribution, tougher controls may follow if abuse isn’t curbed, said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
“There’s an epidemic of prescription drug abuse that is beginning to rival that of illegal drug abuse,” Woodcock said in a telephone interview. “It’s either the kids who get it out of their medicine cabinet or someone who gets multiple prescriptions.”
The medicines cited by the FDA include New York-based Pfizer’s Avinza and Embeda morphine capsules; Duragesic, a fentanyl patch made by New Brunswick, New Jersey-based J&J and generic competitors; Chadds Ford, Pennsylvania-based Endo’s Opana oxymorphone tablets; and OxyContin, an oxycodone tablet made by closely held Purdue Pharma LP of Stamford, Connecticut.
The drugs are sustained-release, high-dose painkillers derived from the opium poppy, also known as opioids. Doctors considered these medicines to be a major breakthrough for cancer and chronic pain when they were introduced in the mid-1990s, though it became clear the drugs were easy to manipulate. Purdue agreed in 2007 to pay $634.5 million to settle claims that promotions for OxyContin from 1996 to 2001 misled doctors about the drug’s risks.
The risk-minimization program is the largest ever imposed by FDA, Woodcock said. The agency gained the authority to require these types of plans as a condition for marketing under 2007 legislation. An estimated 23 million prescriptions for extended-release opioid drugs are written annually, representing about one-tenth of prescription painkillers, according to the FDA.
Pfizer’s King Pharma division, acquired last month, has been developing drugs with physical and chemical properties to resist tampering. Embeda, the first of these medicines, is included in the training program because it hasn’t been proven to be safer than the older medicines, Woodcock said.
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