• Regulatory NewsRegulatory News

    FDA seeks comment on device shortage reporting guidance

    The US Food and Drug Administration (FDA) on Monday released draft guidance on the new notification requirements for reporting medical device discontinuances and manufacturing interruptions created under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).   The CARES Act was signed into law in the early months of the COVID-19 pandemic and, for the first time, established requirements for medical device makers to notify FDA of permanent discontinuances...
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    EC report details EU medicine shortages, offers potential solutions

    A commission ordered by the EC Directorate-General for Health and Food Safety (DG SANTE) to conduct a study on medicine shortages in the EU and European Economic Area (EEA) has released a final report outlining the problem and its recommendations for stakeholders.   Documenting the scope of human medicine shortages in EU/EEA countries between 2004 and 2020, the study conducted by Technopolis Group, Milieu Law & Policy Consulting and Ecorys analyzed data from 22 differe...
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    FDA focuses on efforts made to avert drug shortages in 2020

    New drug shortages in the US decreased in 2020, in part because of the US Food and Drug Administration’s (FDA’s) use of enforcement discretion to ensure an uninterrupted supply of critical medical products during the COVID-19 public health crisis.   Yet, the agency’s new drug shortages report to Congress said that while these actions helped avert shortages in the short-term, more work is needed to improve supply chain resiliency.   This report summarizes the agency...
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    Updated: FDA delays collection of drug manufacturing volume data

    The US Food and Drug Administration (FDA) on Monday announced it will not begin collecting drug manufacturing volume data next month as required by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).   Section 3112 of the CARES Act establishes new reporting requirements for drug manufacturers intended to improve the response to drug shortages, including expanding shortage reporting requirements for life-saving drugs to include drugs that are “critical...
  • Feature ArticlesFeature Articles

    Risk management, drug shortages and the EU portal for clinical trials

    Feature articles during May focused on risk management and mitigation in dealing with contractors and vendors and included articles on best practices in good vendor management, use of risk management to support outsourcing activities, testing in-house versus outsourcing, and outsourcing in regulatory operations. Also included were in-depth examinations of challenges and opportunities in “bespoke” therapies, a critical appraisal of drug shortages in Germany and an update on...
  • Feature ArticlesFeature Articles

    Drug shortages in Germany ‒ A critical appraisal

    This article discusses drug shortages in Germany, the root causes of production problems with active pharmaceutical ingredients, and drug product manufacturers. The authors offer analysis from the perspective of a medium-sized generic drug manufacturer. They outline a range of reasons for the shortages, all of which point to a “broken marketplace.” The authors conclude with a discussion of mitigation activities and address the current COVID-19 pandemic. They warn that drug...
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    FDA Floats Idea of a Rating System for Drug Manufacturers

    The US Food and Drug Administration’s (FDA) Task Force on Drug Shortages supports the idea of creating a new rating system to help drug purchasers, including consumers, better understand the quality management of drug manufacturing facilities. “This idea envisions that pharmaceutical companies could, at their discretion, disclose the rating of the facilities where their drugs are manufactured,” Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, w...
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    UK Updates on Drug Shortage Plans Ahead of Looming Brexit Deadline

    Although the UK has prepared for drug supply issues ahead of a no-deal Brexit on 31 October, Matt Hancock, UK secretary of state for health and social care, explained recently what still needs to be done. Chief among the issues that need to be dealt with is industry readiness for the new customs procedures under a no-deal Brexit and ensuring that industry registers to access new freight capacity. “The Government is establishing a dedicated trader readiness ‘Support U...
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    FDA: US Heparin Supply Not Impacted by African Swine Fever in China

    With shortage concerns looming, the US Food and Drug Administration (FDA) on Monday said that the US heparin supply is not being impacted by the African swine fever in China. “The majority of manufacturers reported no such issues related to African swine fever,” FDA said after reaching out to heparin suppliers. “FDA continues to be in regular contact with US heparin suppliers and manufacturers as this situation evolves.” The update from FDA follows a letter sent in ...
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    With Drug Shortages in Mind, UK Looks to Block Some Parallel Exports

    As part of efforts to prevent drug shortages ahead of a possible no-deal Brexit, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday published a list of 24 medicines that cannot be parallel exported from the UK. The list includes drugs like the hormone therapies estradiol and levonorgestrel, the antiviral oseltamivir, adrenaline, the blood thinner rivaroxaban and the high blood pressure medicine prazosin, among others. The reason why the UK...
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    Michigan Senator Raises Concerns With FDA Over High Numbers of Drug Shortages

    As drug shortages continue to increase in the US, Sen. Gary Peters (D-MI) on Wednesday sent a letter to Acting US Food and Drug Administration (FDA) Commissioner Ned Sharpless seeking more information on what FDA will do. Peters, ranking member of the Committee on Homeland Security and Governmental Affairs, called FDA’s current efforts to combat shortages “not sufficient, given the current state of rising drug shortages in our nation.” He also wrote that he’s “increasin...
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    EMA on Brexit: Risk for Drug Shortages Decreases

    As the UK and EU agreed to extend the Brexit deadline, the European Medicines Agency’s (EMA) Management Board said following its first meeting in Amsterdam that the prospect for centrally authorized products to be at risk of shortage “continues to decrease.”   The board said the risk has gone down because more companies have taken the necessary steps to ensure that their medicines can remain on the market. EMA last September said the number of centrally authorized me...