• FDA Leaning Toward Requiring Generic Opioids to Contain Abuse-Deterrent Qualities, Hamburg Says

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg, writing in a letter to congressional legislators, has determined that the agency has the regulatory authority to require generic medications containing opioids to have abuse-deterrent qualities, providing a potentially significant boost to branded opioid manufacturers who for months have argued that their potential generic competitors should not be allowed to market first-generation non-abuse-deterrent...
  • FDA Guidance 'Incentivizes' Abuse-Deterrence Studies for Opioids

    The US Food and Drug Administration (FDA) has released a new set of draft guidelines pertaining to the regulation and sale of opioid medications with the intent of requiring them to be more abuse-resistant, calling on manufacturers to provide it with specific data to promote the safe and proper use of their opioid products. Leadup to the New Opioid Draft Guidance The move, long anticipated and foreshadowed by Douglas Throckmorton, deputy director of FDA's Center for Dru...
  • US Regulators Looking into New Prescribing Paradigm for Opioids

    US regulators are preparing to hold a meeting regarding the use of opioid drugs to treat chronic pain, and whether new restrictions on their use should be required. In the 19 December edition of the Federal Register , the US Food and Drug Administration (FDA) said that its meeting is meant to address-using scientific data rather than anecdotal reports-ways to minimize the improper use and abuse of opioid drugs while maintaining access for those who rely on the drugs...
  • Bill Proposes National Tracking System for Drug Overdoses

    • 21 August 2012
    The Centers for Disease Control and Prevention (CDC) would be tasked with compiling, analyzing and publishing data on drug overdoses if a new piece of proposed legislation is signed into law. The bill, the Stop Overdose Stat Act (S.O.S. Act) , is more broadly intended to reduce the number of drug overdoses occurring in the US. The bill notes more than 36,000 Americans died from drug overdoses in 2008, with approximately three-in-four of these deaths resulting from a...
  • Proposed Legislation Overhauls Regulatory Environment for Tamper-resistant Opioids

    A new piece of legislation proposed in the US House of Representatives would provide pharmaceutical manufacturers with incentives to develop tamper-resistant products by changing the rules of the competitive landscape. The Stop Tampering of Prescription Pills Act of 2012 , introduced by Rep. Bill Keating (D-MA) on 19 July, would first amend the Federal Food, Drug and Cosmetic Act (FD&C Act) to include a definition for "tamper-resistant drug[s]." Such a product ...
  • Drug Reformulations Lead to Shifting Patterns of Abuse

    A report in the New England Journal of Medicine (NEJM) found abuse of a OxyContin, a branded version of the opioid oxycodone, went down significantly between 2010 and the first quarter of 2012 as the result of a new time-release formulation released in August 2010 by Purdue Pharma. The reformulation made it more difficult to turn the medicine into a powder, thereby reducing an abuser's ability to snort or inject the medication. The article, by Theodore Cicero, PhD, of ...
  • FDA Enacts New Class-wide REMS Policies for Opioids

    The US Food and Drug Administration (FDA) announced 9 July the approval of a new Risk Evaluation and Mitigation Strategy (REMS) for the most potent opioid products on the market, saying in a statement that the new policies are meant to balance patient access and safety measures to improve the safe use of the products. The new REMS policy will cover all extended-release (ER) and long-acting (LA) opioid products, and will rely primarily on educational products, which the m...
  • DEA to Increase Supply of ADHD, Opioid Ingredients in Light of Shortages

    • 06 July 2012
    The US agency in charge of setting drug production quotas for substances regulated under the Controlled Substances Act (CSA) is proposing a mid-year adjustment in its production quotas for the active pharmaceutical ingredients contained within many attention deficit hyperactive disorder (ADHD) drugs and painkillers in response to growing drug shortages. In a 5 July 2012 Federal Register posting, the US Drug Enforcement Administration (DEA) announced it is looking to ...
  • 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 ...