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    Report Calls on FDA to Adopt New Standard for Reviewing Opioids

    The National Academies of Sciences, Engineering and Medicine (NASEM) issued a report Thursday calling on the US Food and Drug Administration (FDA) to change its approach to reviewing opioids in light of the ongoing opioid epidemic. The report, which FDA requested in March 2016 as part of its Opioids Action Plan, argues there is a "scientific and epidemiological basis for special treatment of opioids by the FDA that would involve greater integration of public health consi...
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    Endo Pulls Opioid From US Market at FDA's Request

    Endo International announced Thursday that it will comply with the US Food and Drug Administration’s (FDA) request to remove its opioid Opana ER (oxymorphone hydrochloride extended release) from the US market. FDA made the request 9 June “based on its concern that the benefits of the drug may no longer outweigh its risks” after "a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation.” As a res...
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    FDA to Take Closer Look at Abuse-Deterrent Opioids

    The US Food and Drug Administration (FDA) on Tuesday announced its next move in addressing the ongoing opioid abuse epidemic will be to take a closer look at the data supporting abuse-deterrent labeling for opioids. At a two-day public workshop in July, FDA will meet with experts to look at how the agency can better evaluate the impact that abuse-deterrent opioids have on the growing epidemic. "We recognize that there is a gap in our understanding of whether these pro...
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    Gottlieb Establishes FDA Committee to Confront Opioid Crisis

    Newly-confirmed US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Tuesday began to address what he deems to be his "highest initial priority," which is to "reduce the scope of the epidemic of opioid addiction." As a first step, Gottlieb announced the establishment of an Opioid Policy Steering Committee to bring together some of the agency’s senior career leaders to explore and develop tools or strategies to confront the crisis. The initial quest...
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    Gottlieb to FDA Staff: Immediate Challenge is Opioid Abuse

    Scott Gottlieb, the US Food and Drug Administration’s (FDA) new commissioner, addressed agency staff for the first time late Monday, telling them that "unquestionably, our greatest immediate challenge is the problem of opioid abuse." "This is a public health crisis of staggering human and economic proportion. The epidemic of opioid addiction is not a problem that FDA can solve alone. But we have an important role to play in reducing the rate of new abuse, and in g...
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    10 Hot-Button Issues FDA’s New Commissioner Will Face

    Like his predecessors, Scott Gottlieb, the newly sworn-in commissioner of the US Food and Drug Administration (FDA), will have a full plate to tackle as he takes the reins of the short-staffed agency. Opioid Epidemic At the forefront of the agenda is what Gottlieb called his "highest immediate priority" in the confirmation hearing: the opioid crisis. While acknowledging that FDA’s past actions may have been too incremental, Gottlieb will now have to deal with ...
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    FDA Blueprint for Opioid Education Shifts Focus to Pain Patients

    As the US Food and Drug Administration (FDA) weighs its options for improving healthcare provider training and education on prescribing opioids, the agency is proposing changes to its blueprint for opioid prescriber education. In 2012, FDA instituted a risk evaluation and mitigation strategy (REMS) for extended-release and long-acting (ER/LA) opioids that required companies marketing ER/LA opioids to provide a medication guide and make training available to prescribers. ...
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    Sen. Wyden to HHS: Upcoming FDA Opioid Meeting Full of Conflicts of Interest

    Sen. Ron Wyden (D-OR) is requesting that the US Food and Drug Administration (FDA) delay a workshop on opioids because of the financial conflicts between opioid manufacturers and those participating in the event, according to a letter sent Friday to HHS Secretary Tom Price. The workshop , set for Tuesday and Wednesday, is intended to obtain input on the issues and challenges associated with federal efforts to support training on pain management and the safe prescr...
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    When Does CDER Consult With Controlled Substance Staff? Revised MAPP Explains

    The US Food and Drug Administration (FDA) on Monday released a manual of policies and procedures (MAPP) outlining how its Center for Drug Evaluation and Research (CDER) staff consult with Controlled Substance Staff (CSS) on abuse potential and dependence liability. Since 2000, CDER and CSS, which fulfills a unique role within FDA under the authority of the Controlled Substances Act (CSA) of 1970, have collaborated to evaluate all new drug applications (NDAs), abbrevia...
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    HHS Looks at New Ways to Track Adverse Events Linked to Anticoagulants, Diabetes Drugs and Opioids

    The US Department of Health and Human Services (HHS) on Wednesday proposed six new inpatient and outpatient measures to track as part of efforts to reduce adverse drug events (ADEs) from anticoagulants, diabetes agents and opioid analgesics. Based on input from the Federal Interagency Workgroups for Adverse Drug Events, the six national measures and targets for the reduction of ADEs are being proposed in line with the ADE Action Plan from 2014. The primary ADE...
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    FDA Issues Untitled Letter for Website Promotion of an Opioid 10 Days Before PDUFA Date

    The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) is calling on Durect and Pain Therapeutics to pull promotional materials on their websites for their unapproved Remoxy (oxycodone) extended-release capsules as the sites incorrectly suggest that the investigational new drug is safe and effective. The letter, dated 9 September for Cupertino, CA-based Durect and Austin-based Pain Therapeutics, comes a little more than two weeks b...
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    Senators Question Pfizer, Mylan and Three Other Companies Over Opioid Overdose Treatment Price Hikes

    Sens. Susan Collins (R-ME) and Claire McCaskill (D-MO) sent five identical letters late last week to opioid overdose antidote manufacturers Pfizer, Amphastar Pharmaceuticals, Mylan, Kaléo Pharma and Adapt Pharmaceuticals with new questions on the companies’ price hikes of the life-saving drug naloxone, which has been marketed in the US for decades. The letters, which did not cite any official figures on price increases or make any specific demands of the manufacturers, c...