• Regulatory NewsRegulatory News

    Should FDA Pull Non-Abuse-Deterrent Generic Opioids off the Market? PhRMA, Bio Say Yes

    • 20 January 2015
    The US biopharmaceutical industry's two largest trade groups are calling on the US Food and Drug Administration (FDA) not to approve—or to revoke approval for—generic equivalents of older, non-abuse-resistant painkillers if a drug manufacturer has since made improvements to a drug to make it harder to abuse. Background FDA's regulation of opioid painkillers has a long and complicated history. In recent years, FDA's regulation of opioids had attracted a significant amoun...
  • Regulatory NewsRegulatory News

    DEA Establishes Production Limits for Painkillers, With Some Drugs Set for Big Increases

    US drug regulators have set new production quotas for dozens of controlled substances regulated under the Controlled Substances Act (CSA) , establishing the quantities of the drugs which may be produced in 2015. Quota Adjustments In a 5 September 2014 Federal Register notice , the US Drug Enforcement Administration (DEA), which is charged with setting the quotas, released a list of dozens of schedule I and II controlled substances which will be subject to produc...
  • NIH Looks to Drug Reformulation, Social Media to Combat Opioid Abuse and Misuse

    The US Food and Drug Administration (FDA) may be at the forefront of trying to prevent the misuse and abuse of opioid painkillers, but as two Federal Register notices this week point out, it's not the only agency involved with trying to mitigate risk. On 16 May 2013, the National Institutes of Health (NIH) published two documents in the Federal Register , the government's point of publication for official announcements, indicating that it wants to do more to combat pr...
  • FDA: Stop Manufacturing Unapproved Oxycodone Products

    US regulators said they intend to take enforcement action against manufacturers of unapproved oxycodone products, saying the products constitute a "high public health priority" and have a high potential for misuse and abuse. Oxycodone, an opioid commonly used as a painkiller, is a schedule II narcotic under the Controlled Substances Act (CSA) , meaning it has a high probability of abuse despite its therapeutic uses. FDA said it was made aware of unapproved single-ingr...
  • Insurer Moves to Implement Prescribing Limits for Painkillers

    Federal regulators might soon have company in their long-running battle to reduce the misuse and abuse of painkillers through the adoption of restrictive programs, including Risk Evaluation and Mitigation Strategies (REMS). The Washington Post reports Blue Cross Blue Shield (BCBS) of Massachusetts, the state's largest insurer, is planning to roll out a new plan on 1 July 2012 to limit the supply of painkillers available to patients to just thirty days unless exigent ...