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  • Regulatory NewsRegulatory News

    FDA and DEA Jointly Warn Illegal Online Opioid Networks

    In a first for the US Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA), the agencies came together to warn four online networks operating 10 websites that illegally market unapproved and misbranded versions of opioids. FDA notes that the illegal online pharmacies may put people at risk because there is no guarantee that the medicines are safe and because several of these websites sell opioids online without a prescription. In the warning l...
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    FDA’s New Opioid Packaging Plan is Meant to Limit Overprescribing

    As opioid-related overdoses killed almost 50,000 Americans in 2017, the US Food and Drug Administration (FDA) on Thursday began soliciting comments on a plan to require special packaging for certain types of opioids that might be overprescribed. According to research cited by FDA, most patients use significantly fewer pills than they are prescribed after many common less-invasive surgical procedures as well as some common acute pain conditions treated in the primary car...
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    Drugmaker Petitions FDA to Revoke Sublocade Orphan Designation

    A citizen petition filed last week by law firm Goodwin Procter on behalf of Pennsylvania-based drugmaker Braeburn calls on the US Food and Drug Administration (FDA) to revoke the orphan designation granted to Indivior’s opioid use disorder treatment Sublocade (buprenorphine extended-release injection).   “Sublocade is not now, nor was it ever a bona fide orphan drug, particularly since more than two million Americans currently are afflicted by opioid addiction,” the pe...
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    FDA Takes First Steps to Modify TIRF REMS Program

    The Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) medicines is being strengthened by the US Food and Drug Administration (FDA) to better ensure the appropriate patients are receiving these opioids, the agency announced Wednesday. Following an advisory committee meeting on the REMS last August, as well a recently published study in JAMA that found that “thousands of patients receiving TIRFs were opioid-nontolerant...
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    Public Citizen, FDA Advisor Call for Moratorium on Opioid Approvals

    Nonprofit advocacy group Public Citizen on Thursday filed a citizen petition calling for the US Food and Drug Administration (FDA) to impose a moratorium on approving new or reformulated opioids until the agency implements recommendations from a 2017 report by the National Academies of Science, Engineering and Medicine.   The petition is undersigned by Raeford Brown, the chair of FDA’s Anesthetic and Analgesic Drug Products Advisory Committee who has spoken out again...
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    FDA Plots New Ways to Address Opioid Epidemic in 2019

    While acknowledging “past mistakes” related to the opioid epidemic, the US Food and Drug Administration (FDA) on Tuesday drew up new actions it will take to stem the crisis in 2019. The comments and commitments from FDA follow a report from "60 Minutes"  last Sunday questioning if FDA enabled an expansion of the opioid epidemic. But moving forward, FDA says it has new tools to help combat the crisis. For instance, passage of the Support Act last October has provided...
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    Study Evaluates How an Opioid’s REMS Did Not Work as Intended

    Research published in JAMA on Tuesday details how a US Food and Drug Administration (FDA) class-wide Risk Evaluation and Mitigation Strategy (REMS) did not prevent the inappropriate prescribing of transmucosal immediate-release fentanyls (TIRFs), which were approved solely for breakthrough cancer pain in opioid-tolerant patients. The study, conducted by researchers from the Johns Hopkins Bloomberg School of Public Health and the Center for Science in the Public Intere...
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    FDA Finalizes Buprenorphine Drug Development Guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance on developing new types of buprenorphine depot products for medication assisted treatment (MAT) for opioid use disorder amid the ongoing opioid epidemic.   Buprenorphine, along with methodone and naltrexone, are the only drugs approved by FDA to treat opioid use disorder.   Buprenorphine MAT works by reducing patients’ withdrawal symptoms and blocking the euphoric effects of other opioid drug...
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    FDA Plots Path to Expanding Access to Opioid Overdose Antidote

    An upcoming advisory committee meeting will focus two US Food and Drug Administration (FDA) committees’ attention on increasing the availability of the opioid overdose drug naloxone.   The meeting will ask external advisors from the FDA’s Anesthetic and Analgesic Drug Products and the Drug Safety and Risk Management Advisory Committees to consider various options for increasing access to naloxone.   “They will help us weigh logistical, economic and harm reduction a...
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    Opioids: GAO Calls on HHS to Assess Effectiveness of Expanding Medication-Assisted Treatment

    The Government Accountability Office on Tuesday issued a report calling on the US Department of Health and Human Services (HHS) to assess the effectiveness of efforts to expand the use of medication-assisted treatment (MAT) for opioid addiction. The report follows a House hearing last week in which FDA Commissioner Scott Gottlieb announced several steps the agency will take to promote the development and use of MAT. Background The report and Gottlieb's testim...
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    Gottlieb: Next Steps in Opioid Crisis May be 'Uncomfortable'

    In testimony before the House Energy & Commerce Committee on Wednesday, FDA Commissioner Scott Gottlieb said that the next steps in efforts to combat the ongoing opioid crisis will be difficult, but necessary given the spread of the epidemic. "We'll need to touch clinical practice in ways that may make some parties uncomfortable," Gottlieb said, pointing to restrictions on prescribing and mandatory education for physicians as possible steps. "Long ago we ran out of stra...
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    White House Commission on Opioids to Trump: Declare a National Emergency

    The White House Commission on Combating Drug Addiction and the Opioid Crisis on Monday urged President Donald Trump to declare the opioid crisis a national emergency under the either the Public Health Service Act or the Stafford Act . In an interim report released Monday afternoon, the commission, chaired by New Jersey Gov. Chris Christie (R),  laid out eight specific actions ahead of a final report to be issued sometime in the future, which will include "a f...