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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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    Woodcock Lays Out Top CDER Priorities for 2019

    While noting that the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has reached some important milestones in 2018, CDER Director Janet Woodcock also unveiled the center’s priorities for 2019 at the CMS/FDA Summit in Washington, D.C. on Tuesday. “We’ve generally accomplished what we set out to do” in 2018, she said, noting that in the generic drug space, “we’ve reached a steady state,” while in the new molecular entity (NME) space...
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    Opioids Compromise: What’s in it for FDA

    The US House and Senate late Tuesday reached a consensus on a conglomeration of opioids legislation that will have far-reaching effects for the US Food and Drug Administration (FDA). Among the provisions that will affect FDA include allowing the agency to require prescription opioids to be packaged in a three- or seven-day blister packs, further collaboration with the Customs and Border Protection (CBP) to stop illegal opioids at the border, new public meetings and guid...
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    FDA Plots Policy Priorities for 2018

    The US Food and Drug Administration (FDA) on Thursday announced its priorities for policy activity in 2018, which will include reducing the misuse and abuse of opioids, promoting generic drug and biosimilar competition, creating a total product lifecycle office for medical devices, advancing digital health technologies and strengthening the agency’s workforce. “Our work is taking place during an inflection point in both science and policy,” FDA Commissioner Scott Go...
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    FDA Puts Opioids, Compounding, Stem Cells at Forefront of Enforcement Efforts

    The US opioid epidemic, drug compounding and the proliferation of stem cell clinics selling unproven treatments were highlighted as some of the focal points for US Food and Drug Administration (FDA) enforcement efforts last year and next year, officials said Wednesday at the Food and Drug Law Institute’s litigation and compliance conference in Washington, D.C. Becky Wood, chief counsel for FDA, keynoted the conference and discussed the opioid crisis, and in particul...
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    Abuse-Deterrent Opioids: FDA Finalizes Guidance for Generics

    The US Food and Drug Administration (FDA) last week finalized guidance detailing its expectations for drugmakers looking to develop generic versions of abuse-deterrent opioids. The guidance, which finalizes a draft issued in March 2016 , maintains that generic versions of abuse-deterrent opioids must be "no less abuse deterrent" than the drug they are referencing for all potential routes of abuse. According to guidance, this will help "minimize the risk of shifting abu...
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    Gottlieb Discusses Efficiencies, Opioids, Pricing and More at National Press Club

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb took questions at the National Press Club in Washington, D.C. on Friday, offering perspective on what the agency is doing to be more efficient, actions related to the opioid epidemic and how FDA plays a role in the drug pricing debate. In the question and answer section of the talk, Gottlieb noted the agency will be putting forth more guidelines to drive efficiencies in the development of new therapi...
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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: Immediate Release Opioids to be Subject to REMS

    FDA Commissioner Scott Gottlieb on Thursday said that immediate-release (IR) opioids will be subject to the same risk evaluation and mitigation strategy (REMS) as extended-release and long-acting (ER/LA) opioids. The agency first required a REMS for ER/LA opioids in 2012. "This week, we issued letters notifying 74 manufacturers of IR opioid analgesics intended for use in the outpatient setting that their drugs will now be subject to a more stringent set of requirements,...
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    FDA Considers WHO Scheduling Change for 17 Drug Substances

    The US Food and Drug Administration (FDA) on Friday sought public comments to help prepare a response to the World Health Organization (WHO) regarding the abuse liability and diversion of 17 drug substances, many of which are opioids and similar to fentanyl. WHO will consider whether to recommend certain international restrictions be placed on the drugs. Background Section 201 of the Controlled Substances Act (CSA) provides that when WHO notifies the US under Art...
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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...