Pharmaceutical executives, representing 24 different companies, today met with representatives of the Food and Drug Administration (FDA) to try and find answers to the misuse of prescription pain pills.
It is the first time the agency has asked drug makers to come up with a risk-management plan for an entire class of drugs, in this case opioids, reports AP.
An estimated 5.2 million Americans misuse prescription painkillers annually, a 2007 survey found.
In February, the agency asked 16 companies to come up with risk-management plans for prescription painkillers that are often abused and lead to hundreds of fatal overdoses a year including morphine, oxycodone, and methadone.
The drugs are used to treat chronic pain in cancer patients, but are also prescribed off-label for uses such as migraine headaches. The opioids can get into the hands of those other than the intended patient, and an extended-release pill, designed to be swallowed if chewed, can cause an accidental overdose.
Dr. John Jenkins of the FDA’s Office of New Drugs, said in February that the agency was undertaking a relatively massive new program because of the rising rates of misuse and abuse.
Executives from Johnson & Johnson and King Pharmaceuticals, opioid drug makers, proposed including patient medication guides, sending letters to doctors and additional physician training, but agency officials said more specific plans are needed to prevent the misuse of prescription painkillers and they ordered executives back to the drawing board.
Johnson & Johnson makes the Duragesic patch, King Pharmaceuticals makes the extended-release Avinza and Embeda pills, and Purdue Pharmaceuticals makes extended release OxyContin.
In 2007, the FDA was given greater authority to regulate opioids under the Food and Drug Administration Amendments Act of 2007.
In September, Purdue applied with the Food and Drug Administration to reformulate the pill to reduce the chances of misuse or abuse.
Purdue Pharma LP wants the drug to be tamper-resistant so it’s harder to crush and the active drug is released as a gel making it harder to inject, according the FDA staff reporting on the agency’s Web site.
Drug abusers typically dissolve or crush the drug and put it in water to inject it for a heroin-like effect.
Two years ago, the company had to pay $635 million to settle federal charges that it underplayed the drug’s potential for abuse. Addiction rates are reported to be between 1 and 13 percent.
Don't expect any changes any time soon. The FDA plans to hold another public hearing in the spring before finalizing the requirements. #