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  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    FDA Offers Draft Guidance on Generic Versions of Opioid Overdose Nasal Spray

    As the opioid epidemic continues to spread, the US Food and Drug Administration (FDA) is looking to alleviate some of that pain by offering new draft guidance to generic drug companies looking to develop generic versions of the nasal spray that can reverse opioid overdoses. The draft guidance is meant to help companies understand what studies need to be conducted to win approval for generics of Adapt Pharma’s Narcan nasal spray, also known as naloxone hydrochloride ...
  • Regulatory NewsRegulatory News

    FDA Calls for Boxed Warning on Two Drug Classes

    The US Food and Drug Administration (FDA) says it is requiring two classes of drugs, opioids and benzodiazepines, to bear a boxed warning over serious and sometimes fatal risks when the two drugs are used in combination. "It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together," said FDA Commissioner Robert Califf. "We implore health care professionals t...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    FDA Science Board Addresses US Opioid Epidemic

    The US Food and Drug Administration’s (FDA) Science Board met Tuesday to discuss pain management and opioid abuse, offering a number of ways to address a topic that’s caught the attention of Congress as overdose deaths mount. At the outset of the meeting, newly confirmed FDA Commissioner Rober Califf told the panel -- which is advising FDA on the role of pharmaceuticals in pain management, development of alternative medications and postmarketing surveillance activities –...
  • Regulatory NewsRegulatory News

    OTC Opioid Overdose Antidote: Why is it not FDA Approved?

    The case of the opioid overdose antidote naloxone (also known as Narcan) offers an interesting look at how states can offer a prescription drug without a prescription at local pharmacies, even though the US Food and Drug Administration (FDA) has not approved it as an over-the-counter drug. Prescription opioid overdose deaths in the US are now the leading cause of injury death – surpassing motor vehicle crashes. And between 2000 and 2014, the rate of deaths from drug over...
  • Bill Proposes National Tracking System for Drug Overdoses

    • 21 August 2012
    The Centers for Disease Control and Prevention (CDC) would be tasked with compiling, analyzing and publishing data on drug overdoses if a new piece of proposed legislation is signed into law. The bill, the Stop Overdose Stat Act (S.O.S. Act) , is more broadly intended to reduce the number of drug overdoses occurring in the US. The bill notes more than 36,000 Americans died from drug overdoses in 2008, with approximately three-in-four of these deaths resulting from a...