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  • FDA Issues New Opioid Guidelines, But Critics Say They’re Not Enough

    FDA Issues New Opioid Guidelines, But Critics Say They’re Not Enough

    The new guidelines say that the FDA should consider whether or not a new opioid works better than existing pain relief options.

    The Food and Drug Administration has issued new guidelines about how it should consider applications for approval of new opioids, but some critics are questioning whether the new plan does enough to restrict the harm of potentially deadly medications. 

    The FDA issues the new guidelines on June 20. The guidelines are meant to give a risk-benefit analysis over how new opioids will help patients who use them correctly, but also how they may affect people using opioids illegally. This is a departure for the agency, which usually only considers a drug’s safety when it is taken as prescribed. 

    “Opioids present unique challenges: they have benefits when used as prescribed yet have very serious risks and can cause enormous harm when misused and abused,” the agency said in a statement released at the same time. 

    Still, some people don’t think that the guidelines are enough to prevent the FDA from approving drugs that could worsen the opioid epidemic. One consumer advocacy group, Public Citizen, has demanded that the FDA halt approval of all new opioids until stricter guidelines are in place. 

    Sidney Wolfe, a former member of an FDA advisory committee and a policy expert for Public Citizen, told Pacific Standard that she was not satisfied with the new guidelines. 

    “If this is their view of what should go into a opioid framework, that is not acceptable,” she said. 

    The new guidelines say that the FDA should consider whether or not a new opioid works better than existing pain relief options. However, the guidelines don’t require that the agency reject approval for medications that do not work better than existing options, Wolfe said.

    In addition, the guidelines say that the agency will consider how opioids could be misused, but it does not require companies to provide information on potential misuse before they are given FDA approval. The guidelines are not legally binding. 

    Despite the shortcomings, some people who are in favor of stricter oversight over opioids are happy to see the guidelines issues. 

    “What I can say is that we are pleased that the agency has taken this first step in implementing our recommendations,” said University of Virginia professor Richard Bonnie, chair of a National Academies panel that called on the FDA to develop a special process for approving new opioids. 

    The FDA has come under fire for its role in the opioid epidemic. 

    “The opioid crisis is one of the largest and most complex public health tragedies that our nation has ever faced,” a spokesperson for the agency told Vanity Fair for a recent article. “Sadly, the scope of the epidemic reflects many past mistakes and many parties who missed opportunities to stem the crisis, including the FDA.” 

    View the original article at thefix.com

  • FDA Considers Limiting Outpatient Opioid Prescriptions

    FDA Considers Limiting Outpatient Opioid Prescriptions

    The FDA is taking feedback from the public as it weighs the decision to reduce high-dose prescription painkillers delivered in outpatient settings. 

    Advisors for the Food and Drug Administration (FDA) met last week to discuss a possible cap on high-dose opioids delivered in an outpatient setting, a move that is intended to reduce the risk of addiction and dependency. 

    According to MedPage Today, the meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesia Drug Products Advisory Committee included presentations by doctors, and discussions by policymakers. 

    In a memorandum released ahead of the meeting, advisors for the FDA said that the conference aims to address dual concerns. 

    “When considering regulatory strategies relating to opioid analgesics, FDA always considers two fundamental public health goals: 1. We want to reduce opioid misuse, abuse, addiction, overdoses and deaths. 2. We want to ensure that products are available to meet the medical needs of people living with debilitating pain,” the memo read. 

    “We are also interested in discussing the magnitude and frequency of harms associated with higher doses of opioid analgesics relative to lower doses, as well as optimal strategies for managing these risks while ensuring access to appropriate pain management for patients,” Judy Staffa, associate director for the Public Health Initiatives Office of Surveillance and Epidemiology at the Center for Drug Evaluation and Research (CDER), wrote in the memorandum that was sent to conference attendees. 

    Restricting highly addictive high-dose opioids while also meeting the needs of patients with chronic pain has been a delicate balancing act that many people feel has not been addressed well by federal regulators. The meeting last week was an attempt to continue discussions about how best to serve both needs. 

    “There is a strong need to bring together the community of stakeholders to consider the collective scientific understanding of the issues relating to higher daily doses and higher dosage strength opioid analgesic products and potential strategies to reduce risks to patient and public health,” Staffa wrote. 

    Dr. Ning Hu, medical officer of the CDER’s Division of Anesthesia, Analgesia, and Addiction Products, said that high-dose opioids are dangerous, but so is uncontrolled pain, which—in the most severe cases—can cause people to consider suicide.

    Many prescribers followed the CDC’s 2016 guidelines for prescribing opioids, but those were interpreted too drastically, Hu wrote. 

    “The guidelines were misinterpreted and misapplied, contributing to substantial harms to patients, particularly patients with chronic pain who were forced to taper their previously stable opioid doses to lower doses, or who were forced to discontinue their opioids through forced tapers or patient abandonment,” Hu wrote. 

    In addition to the discussions happening at the conference, the FDA has opened public comment on the issue of high-dose opioids. Public comment will remain open through June 30, and is available here. 

    View the original article at thefix.com