Answer Addiction

Tag: new opioids

  • FDA Rejects Petition For Moratorium On New Opioids

    FDA Rejects Petition For Moratorium On New Opioids

    The FDA explained its decision to continue accepting applications for new opioids in a written response. 

    The Food and Drug Administration has rejected a request for a moratorium on the approval of new opioid drugs.

    The petition for a moratorium was launched by the Public Citizen’s Health Research Group in April of this year. It requested that the FDA hold off on approving new opioids until the organization adopted recommendations made by the National Academies of Sciences, Engineering, and Medicine’s 2017 report, “Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use.”

    The FDA issued a written response to the request last week, denying the petition. 

    Why The FDA Denied The Request

    “While the FDA is committed to continuing its ongoing work of scrutinizing how it applies its benefit-risk framework to candidate opioids, and to exploring whether additional authority from Congress is needed, FDA must also continue to apply the existing statutory and regulatory framework to properly filed [new drug applications], including applications for new opioid drug products or opioid formulations,” the agency wrote. 

    “Furthermore, a moratorium on the approval of new opioid drug products could stifle the development and availability to patients of new opioids that could offer greater safety or other therapeutic advantages over products already on the market.”

    The FDA went on to state that even after a new drug is approved, it is still closely monitored to make sure that its benefits outweigh its risks. The FDA has taken steps to mitigate the risk of opioids, including changing labeling, the agency says. 

    Approving A New Opioid That’s Stronger Than Fentanyl

    Last year, the FDA ruffled feathers by approving a controversial new opioid that is 10 times stronger than fentanyl. The medicine, Dsuvia, is a version of sufentanil intended only for use in hospitals, the FDA said. Many people, including a member of the FDA’s own advisory committee, spoke out against the approval of the drug. 

    “It is certain that Dsuvia will worsen the opioid epidemic and kill people needlessly,” Dr. Sidney Wolfe of Public Citizen’s Health Research Group (the same group that requested the moratorium) said in a press release at the time. “It will be taken by medical personnel and others for whom it has not been prescribed. And many of those will overdose and die.”

    Raeford Brown Jr., MD, chair of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee spoke strongly against the approval of the drug, even writing an open letter in opposition: 

    “It is my observation that once the FDA approves an opioid compound, there are no safeguards as to the population that will be exposed, the post-marketing analysis of prescribing behavior, or the ongoing analysis of the risks of the drug to the general population relative to its benefit to the public health,” he wrote.

    “Briefly stated, for all of the opioids that have been marketed in the last 10 years, there has not been sufficient demonstration of safety, nor has there been post-marketing assessment of who is taking the drug, how often prescribing is inappropriate, and whether there was ever a reason to risk the health of the general population by having one more opioid on the market.”

    View the original article at thefix.com

  • 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