• ReconRecon

    Recon: Abbvie and Calico craft $1B deal; Purdue creditors sign deal to shield Sacklers

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US How Biogen found a believer: At the FDA, a hard-nosed regulator was won over on controversial Alzheimer’s drug ( STAT ) AbbVie hits go on $1B re-upped Calico deal as the Google life science spin-out continues I-O, neuro push ( Fierce ) Biden wants to bolster the pharma supply chain. A major generic plant closing may make that harder ( STAT ) CDC to reverse ind...
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    FDA seeks comments on regulation of kratom, 6 other drugs

    Kratom, a popular but unregulated psychotropic herbal extract, is one of seven currently unscheduled psychotropic drugs that will be reviewed by the World Health Organization (WHO) under the provisions of the international psychotropic convention to which the US is a party.   WHO notified the US and other international parties to the 1971 convention that the seven new psychotropic drugs may be added to its list of scheduled drugs. By law, that notification triggers a r...
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    FDA withdraws 5 opioid ANDAs for no REMS or reports

    Five generic opioid drugs are being withdrawn from the market by the US Food and Drug Administration (FDA), according to a Federal Register announcement.   The action comes after the holders of the abbreviated new drug applications (ANDAs) “have repeatedly failed to file required annual reports for those ANDAs and have failed to satisfy the requirement to have an approved risk evaluation and mitigation strategy (REMS),” wrote FDA in announcing the withdrawal.   T...
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    FDA seeks comment on plan to increase REMS transparency

    The US Food and Drug Administration (FDA) is seeking to be more transparent about its Risk Evaluation and Mitigation Strategy (REMS) program.   The agency is seeking public comment on its plan to publish its evaluations of how individual drug and biologics sponsors are doing on the implementation of REMS programs.   REMS is a long-standing drug safety program that allows the FDA to require manufacturers to implement specific safety measures that go beyond drug labe...
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    Consider a variety of endpoints for OUD treatments: FDA guidance

    Consider a variety of endpoints for OUD treatments: FDA guidance   A new final guidance document from the US Food and Drug Administration (FDA) gives drugmakers considerations for choosing endpoints for new medications to treat opioid use disorder (OUD).   “We recognize that there’s great interest in developing new treatment options that result in meaningful outcomes, said FDA Commissioner Stephen Hahn, MD, in announcing the final guidance, which has only minor c...
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    Wide swath of online opioid sellers warned by FDA

    Seventeen website operators recently received warning letters from the US Food and Drug Administration (FDA) for selling unapproved and misbranded opioids. The letters were issued on 31 August 2020 to operators of websites based in China, Iceland, India, New Zealand, Pakistan and the United States.   Operators of the websites, which carry names such as “www.buydrugsmedsonline.com” and “www.beststeroidstore.net,” were warned for offering opioids such as oxycodone and tr...
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    FDA seeks input on genotyping for pediatric codeine use

    The US Food and Drug Administration (FDA) is seeking public consultation on whether children under the age of 12 years should be permitted to receive analgesics containing codeine, if they have been cleared from having a genetic tendency to metabolize the drug at potentially toxic levels.   Currently, the use of products containing codeine is contraindicated in children under the age of 12. Codeine, an opioid indicated for relief of mild to moderate pain under some cir...
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    FDA takes aim at online opioid sellers with new pilot

    The National Telecommunications and Information Administration (NTIA) will partner with the US Food and Drug Administration (FDA) in a pilot aimed at reducing the online sale of illicit opioids.   During the 120-day pilot, FDA will notify participating internet registries when a website operator does not respond adequately, or within the required time frame, to a warning letter. An agency of the US Department of Commerce in the Executive Branch, NTIA oversees telecom...
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    Interview: FDA’s Cohen on OTC naloxone labeling study

    An over-the-counter formulation (OTC) of naloxone could expand the availability of a life-saving tool in addressing the opioid crisis, since the medication can rapidly and safely reverse opioid overdose. The US Food and Drug Administration (FDA) has developed a model consumer label for OTC naloxone and conducted a consumer behavior study; these results were published this week in the New England Journal of Medicine .   RELATED: FDA labeling study helps clear path...
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    FDA labeling study helps clear path for OTC naloxone

    Consumers reading a model drug facts label for naloxone could understand labeling sufficiently to use the opioid antagonist safely and effectively without the support of a healthcare provider, according to a label-comprehension study conducted by the US Food and Drug Administration (FDA).   The unusual move by the FDA could help clear a hurdle to approval of over-the-counter injectable and intranasal naloxone; many public health experts concerned about the impact of th...
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    FDA Lays Out Plan for Comparing New Opioids to Previously Approved Ones

    The US Food and Drug Administration (FDA) on Thursday released new draft guidance on its benefit-risk assessment framework for opioids, outlining how the agency plans to compare the effectiveness and safety of new opioids with already approved opioids. The idea for a comparative approval standard, discussed by former FDA Commissioner Scott Gottlieb in March before a Senate committee, hinges on the fact that “FDA believes that there should be a premarket demonstration ...
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    CDER Develops New Method to Evaluate an Opioid’s Safety Risk

    As fentanyl analogs present a major risk to public health, and as these analogs can evade prosecution, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has developed a new computational approach to understand these often-unidentified chemicals better and to assist with drug scheduling. The new approach, called Public Health Assessment via Structural Evaluation (PHASE), can evaluate the similarity of a newly identified drug of ab...