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    European Regulatory Roundup: EMA Plans Ways to Curb Antibiotic Resistance (2 June 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Proposes Restricting Use of Colistin to Curb Rise of Antibiotic Resistance The European Medicines Agency (EMA) is proposing to restrict the use of colistin to curb the rise of antibiotic resistance. Under the plan, use of colistin in animals would be limited to last-resort cases, a constraint intended to quell concerns that an emerging resistant mutation will spread quic...
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    FDA: Generic Opioids Must be 'No Less' Abuse-Deterrent Than Brand-Name Versions

    The US Food and Drug Administration (FDA) released a new draft guidance intended to ensure that generic versions of abuse-deterrent opioids meet the same standards for abuse deterrence as their brand-name counterparts for public comment on Thursday. The new draft guidance is part of a wider effort by FDA to address the national opioid epidemic, which claimed the lives of more than 28,000 Americans in 2014 . In February, the agency detailed its opioids action plan, sa...
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    Senate Democrats Call for FDA, NIH Funding Boost as Other Bills Emerge

    Sens. Elizabeth Warren (D-MA) and Patty Murray (D-WA) on Thursday introduced a bill that would provide $5 billion per year in new funding for the Food and Drug Administration (FDA) and National Institutes of Health (NIH). The boost in funds for FDA and NIH, backed by the Health, Education, Labor & Pensions (HELP) Committee Democrats, comes almost a month after the committee, still looking to pass companion legislation to the House-passed 21st Century Cures bill , advan...
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    State Health Officials Petition FDA for New Warnings on Opioids, Benzodiazepines

    Concerns over the risks of co-prescribing benzodiazepine and opioid drugs has 41 state health officials petitioning the US Food and Drug Administration (FDA) to place a new black box warning on both classes of pharmaceuticals to warn patients and doctors of the potential risks with concomitant use. “Only a few labels and medication guides contain specific information on the dangers of concurrent use of these two classes of medications; none contain black box warnings,” t...
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    FDA Calls for New Opioid Hearings as Califf Readies for Monday’s Senate Vote

    Three new expert committee meetings on opioids were announced by the US Food and Drug Administration (FDA) this week as two Democratic senators continue to oppose Robert Califf’s nomination as the next FDA commissioner ahead of a Senate vote on Monday. Before that vote, Sens. Ed Markey (D-MA) and Joe Manchin (D-WV) said they will hold a press conference to discuss why they’re opposed to Califf’s nomination. Markey has previously taken issue with FDA’s  approval of the us...
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    Updated: Governor Takes Issue With Super Bowl Drug Ad as New House Bill Looks to Restrict DTC Pharma Advertising

    [Editor's note: This story was updated with new details on the text of the DeLauro bill to restrict DTC pharma advertising and new details on a letter from AstraZeneca to Gov. Shumlin]. Vermont Gov. Peter Shumlin (D) has sent a letter to pharmaceutical companies AstraZeneca and Daiichi Sankyo calling on them to pull their advertisement that aired during the Super Bowl. The ad promoted a drug to treat opioid-induced constipation. “Like many Americans, I was baffled by th...
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    New Law Redefines When Controlled Substances are Officially Approved

    Just before the Thanksgiving holiday weekend, President Barack Obama signed a new law that will effectively provide the pharmaceutical industry with more certainty on when controlled substances are officially approved. The new law, known as the Improving Regulatory Transparency for New Medical Therapies Act, sets new deadlines for the US Drug Enforcement Administration (DEA) to schedule controlled substances, like opioids and other drugs that have the potential to be abu...
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    Legislators Press FDA to Add Black Box Warning to Immediate-Release Opioids

    A group of nearly two dozen Democratic legislators is calling on the US Food and Drug Administration (FDA) to label immediate-release opioids with more serious warnings meant to reflect "the serious risks of abuse" associated with the drug. In a letter sent on 4 June 2015 to FDA Acting Commissioner Stephen Ostroff, the legislators said their concerns are driven by "the national public health crisis of prescription drug overdoses." Opioid-related overdoses and deaths have...
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    Tougher FDA Approval Process for Opioids Sought by Congress

    New legislation introduced by a bipartisan group of US senators would make it more difficult for new and generic opioid drugs to obtain the approval of the US Food and Drug Administration (FDA). Background The bill, the FDA Accountability for Public Safety Act (FAPSA) , is a response to FDA's regulation of opioid painkillers, and specifically one known as Zohydro. The drug was approved in October 2013 as a pure hydrocodone product lacking any physical characteristi...
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    FDA Finalizes Approach to Abuse-Deterrent Opioids

    Federal regulators have at long last finalized a policy which establishes voluntary guidelines by which manufacturers of opioid-based painkillers can prove that their products are resistant to misuse and abuse by patients. Background The abuse of opioid painkillers in the US is a major problem. There were an estimated 16,235 opioid-related overdose deaths in the US in 2013, and recent studies have found that nearly a quarter of all patients on opioids misuse the dru...
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    FDA to Publish Biosimilars Labeling, Generic Opioids Guidance Later This Year

    US pharmaceutical regulators with the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) say they plan to release two new guidance documents on, separately, the labeling of biosimilar products and how companies can evaluate abuse-deterrent properties of generic solid oral opioid drugs. News of the new guidance documents, which FDA anticipated will come out before the end of the year, came in an updated "Guidance Agenda" document the ...
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    Should FDA Pull Non-Abuse-Deterrent Generic Opioids off the Market? PhRMA, Bio Say Yes

    • 20 January 2015
    The US biopharmaceutical industry's two largest trade groups are calling on the US Food and Drug Administration (FDA) not to approve—or to revoke approval for—generic equivalents of older, non-abuse-resistant painkillers if a drug manufacturer has since made improvements to a drug to make it harder to abuse. Background FDA's regulation of opioid painkillers has a long and complicated history. In recent years, FDA's regulation of opioids had attracted a significant amoun...