FDA announces changes to Rx painkiller approval process

New rules include additional labeling requirements

FDA on Thursday announced that, in response to a growing opioid misuse epidemic in the United States, it will change its approval process for prescription painkillers.

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Details of the changes

FDA said that it will ensure the agency considers drugs' broader public health effects during the approval process. And before approving any opioid drugs that do not have abuse-deterrent properties, the agency said will seek input from independent advisory panels.

In addition, FDA said it will:

  • Bolster requirements for drugmakers to produce post-market data on the long-term effects of opioid painkiller use;
  • Develop additional safety information for immediate-release prescription opioids;
  • Increase access to pain management training for physicians and other prescribers;
  • Require drugmakers to place additional warnings and safety information on drug labels; and
  • Work to improve access to medication-assisted treatment for substance use disorders and to naloxone, a drug that can reverse an opioid overdose.

Robert Califf—FDA's deputy commissioner for medical products and tobacco and President Obama's nominee to lead the agency—says FDA is "determined to help defeat this epidemic through a science-based and continuously evolving approach." He adds, "This plan contains real measures [FDA] can take to make a difference in the lives of so many people who are struggling under the weight of this terrible crisis."

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Sen. Ed Markey (D- Massachusetts), who has pledged to block Califf's nomination until FDA agrees to implement a more comprehensive review of its approval process for prescription painkillers, in a statement said the changes "fall short of what is needed." Markey added that he would not lift his hold on Califf's nomination.

Sen. Joe Manchin (D-West Virginia), who has similarly said he would block Califf's nomination, in a statement said he was "not impressed" by FDA's plan, adding that the agency must do more to address the opioid misuse crisis.

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Andrew Kolodny, executive director of Physicians for Responsible Opioid Prescribing, says he expects that most of FDA's actions "will have little impact." He dismissed FDA's announcement as a "public relations" ploy, noting that the agency has "been getting beat up for their opioid decisions."

According to Kolodny, overprescribing of prescription painkillers is the root of the crisis, and FDA allows the drugs to be prescribed too broadly. Further, he notes that some labels "have no duration of use mentioned, or upper dose limits."

Similarly, Nathaniel Katz, an assistant professor of anesthesia at Tufts University School of Medicine, says, "What I'm seeing here is the FDA attempting to say something in response to congressional concerns, perhaps in response to the holdup of approval of the new FDA commissioner, without actually having any vision for change" (Burton, Wall Street Journal, 2/4; American Health Line, 2/4; Ross Johnson, Modern Healthcare, 2/4; Clarke, Reuters, 2/4; Tavernise, New York Times, 2/4; Ferris, The Hill, 2/4).

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