FDA Seeks Better Regulation of Painkillers

MONDAY Feb. 9, 2009 -- The U.S. Food and Drug Administration announced plans Monday to tackle growing concern over the misuse of powerful painkillers by requiring manufacturers of certain opioid drugs to help develop a plan to reduce the risks associated with the medications.

The FDA said it has sent letters to 16 pharmaceutical companies that collectively manufacture the two dozen drugs that will be subject to the new review.

The requirement could ultimately take the form of additional warning labels, physician instructional materials, and stricter prescription indications, officials said.

Speaking at a Monday teleconference, Dr. John Jenkins, director of the FDA's Office of New Drugs, part of the Center for Drug Evaluation and Research, said that approximately 21 million prescriptions for 3.7 million patients were issued in 2007 for the targeted medications. They include brand-name and generic versions of morphine, oxycodone, fentanyl, and methadone.

Such drugs are typically approved for patients requiring round-the-clock treatment for moderate to severe chronic pain, such as cancer patients.

But, significant harm -- resulting in hundreds of deaths each year -- can occur if patients are uninformed about how to properly take the drugs; doctors inappropriately prescribe the drugs; or if legitimate prescriptions get into the hands of people other than the intended patient, Jenkins said.

Jenkins said the agency was taking this step to implement "a relatively massive new program," because "the rates of misuse and abuse [of opiates] have risen over the past decade." He also said the FDA was better able to address the problem, because the Food and Drug Administration Amendments Act of 2007 gave the agency the authority to regulate opioids.

Jenkins called the new program a multi-pronged and complex effort that will take several months to put in place, after an initial meeting with the drug manufacturers, scheduled for March 3.

Patient advocacy groups and health professionals involved with the treatment of pain and addiction will also be consulted during the development of the new drug protocols, which are officially known as "Risk Evaluation and Mitigation Strategies," or REMS.

This is "our attempt to try and ensure that the benefits of the products outweigh their risks," Jenkins said. To that end, he said, the FDA will try to strike an "appropriate balance" between legitimate patient need for access to such drugs and the very real threat posed by their abuse and intentional or unintentional misuse.

Also speaking at the press conference, Dr. Bob Rappaport, director of the FDA's division of anesthesia, analgesia, and rheumatology products, underscored the agency's growing concern over the inappropriate use of opiates by citing several alarming statistics.

For example, he noted a just released national survey that found that in 2007, 5.2 million Americans aged 12 or older said they had used prescription pain relievers in the prior month for non-medical purposes.

"So this is an ongoing problem, and it's getting worse," Rappaport said.

Posted: February 2009


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