Drugs

PMRS Wants Opioid Chronic Indications Revoked

David McFarland

— 1 min read
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Horsham, PA-based contract manufacturer Pharmaceutical Manufacturing Research Services (PMRS) is asking FDA to revoke all indications for use of any opioids in management of chronic pain, saying there is insufficient evidence to support such an indication. Specifically, the group is asking that the agency: 

  •          revoke approval of OxyContin’s indication for “management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatments are inadequate” and all supporting chronic use labeling;
  •          revoke approval of all extended-release opioids indicated for “management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatments are inadequate”; and
  •          revoke approval of all immediate release opioid drug product labeling supporting use for the treatment of chronic pain, changing the labeling to an indication for acute pain for a limited duration.

PMRS says “the root cause of the United States opioid epidemic is FDA’s approval of opioid drug products for the treatment of chronic pain absent substantial evidence of efficacy. Exacerbating the problem, the FDA-approved labeling provided the medical community with false reassurance that OxyContin was safe and effective in the treatment of chronic pain when there was never any evidence to justify such an indication. This led the medical community to change its long-held beliefs and practices about prescribing low-dose opiates only for acute injury and only for short durations due to severe risk of addiction and lack of empirical data of efficacy for chronic pain. Conventional wisdom changed when high-dose OxyContin was unlawfully approved for chronic pain and extended duration, and this sowed the seeds of the opioid epidemic.”

According to PMRS, when FDA approved OxyContin in 2001, it did not conduct or require the sponsor to conduct sufficient testing to reasonably conclude that substantial evidence existed to change the indication from acute to chronic. “Such approval in the absence of substantial evidence violates the Federal Food, Drug, and Cosmetic Act,” it asserts. Sixteen years later, the petition says, there is still insufficient scientific or substantial evidence for using opioids in treating chronic pain, as confirmed by the Centers for Disease Control in its 2016 opioid prescribing guidelines.

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