FDA to Step Up Regulation of Extended-Release Opioids

By H Bomber · Jun 15, 2009 · Updated Jun 16, 2009 · ·
  1. H Bomber
    FDA to Step Up Regulation of Extended-Release Opioids


    Copy the code below to embed audio on your website or blog:
    AUDIO: John Jenkins, M.D., Director, Office of New Drugs, FDA Center for Drug Evaluation and Research​
    ROCKVILLE, Md., Feb. 9 -- The FDA has begun a "massive new program" to stem abuse of opioid painkillers, putting the onus on manufacturers to develop new misuse-prevention programs.

    The effort is likely to set up new hoops that physicians must jump through in prescribing these agents, currently used by millions of Americans.

    On Friday, the agency sent letters to 16 companies that make 24 extended-release and patch formulations of opioid drugs, informing them that they will have to develop formal risk evaluation and mitigation strategies for the products.
    Among the drugs covered by the letters are Purdue Pharma's extended-release oxycodone (OxyContin), Ortho McNeil Janssen's fentanyl patch (Duragesic), and Endo Pharma's extended-release oxymorphone tablet (Opana), along with generic versions.

    Generic and branded versions of morphine, methadone, and hydromorphone are also included.

    "This will be a relatively massive new program," said John Jenkins, M.D., director of new drugs in the FDA's Center for Drug Evaluation and Research, in a press briefing today.

    He estimated that some 21 million prescriptions are written annually for products covered by the letters.

    Dr. Jenkins said clinicians would likely see new procedures for writing prescriptions for these painkillers and patients would face hurdles in filling them, although the specifics remain to be worked out and may vary by product.

    The plans will take several months to unfold, Dr. Jenkins said.

    The first step will be a March 3 meeting between FDA staff and the 16 manufacturers.

    Additional steps will include discussions with other federal agencies -- such as the Drug Enforcement Administration -- patient and consumer advocates, representatives of the pain and addiction treatment communities, and other healthcare professionals.

    Dr. Jenkins said a public meeting would be held in late spring or early summer to allow for broader public input and participation.

    "Nothing is changing immediately," he emphasized. "This is obviously a very complex undertaking, so it will take some time."

    He said that the programs would likely include a training element for physicians to educate them on the risks of extended-release opioids and how to minimize them for individual patients.

    The move represents the FDA's most significant use yet of authority it was granted under the Food and Drug Administration Amendments Act of 2007.

    Previous risk evaluation and mitigation programs have put significant paperwork responsibilities on physicians and patients.

    For example, the program governing the acne treatment isotretinoin (Accutane) required that women of child-bearing age provide proof of a negative pregnancy test before they could receive the drug, a known teratogen.

    Bob Rappaport, director of the FDA unit overseeing anesthesia and analgesic drugs, said new survey data indicate that "non-medical" use of pain medications is growing in children as well as several adult age groups.

    By John Gever, Senior Editor, MedPage Today
    Published: February 09, 2009


    Primary source: FDA
    Source reference:
    "FDA to Meet with Drug Companies about REMS for Certain Opioid Drugs" FDA 2009

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