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  • Regulatory NewsRegulatory News

    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...
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    Asia Regulatory Roundup: Indian Court Rejects Abbott’s Plea to Stop Probe into Alleged Diabetes Cartel

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Posts Guidance on How to Manage and Communicate Drug Shortages   Australia’s Therapeutic Goods Administration (TGA) has posted guidance on the communication and management of drug shortages. The publication of the document comes five weeks before Australia makes the reporting of medicines shortages mandatory.   TGA proposed moving to a mandatory model in Apri...
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    More Than 100 Days After Hurricane Maria, Drug Shortages Situation Expected to Improve

    The US Food and Drug Administration (FDA) on Thursday announced that shortages of IV saline are expected to improve early this year as Baxter – a leading producer of IV saline fluids – has said all its facilities on Puerto Rico have now returned to the commercial power grid. The good news on Baxter comes as the agency said all other companies that were on an initial list of drugs considered at risk of potential shortages – because the drugs were largely or entirely...
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    FDA Allows Temporary Saline Imports to Deal With Shortages Caused by Hurricane Maria

    Baxter Healthcare said in letters to health care professionals dated Monday that it is working with the US Food and Drug Administration (FDA) to import sodium chloride and glucose intravenous infusion products from Ireland and Australia to address shortages because of Hurricane Maria. The temporary imports are manufactured at Baxter facilities in Ireland and Australia and the company notes that at this time, "No other entity except Baxter is authorized by the FDA t...
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    EMA Preps for Staff Shortages, Possible 'Major' Budget Deficit

    Although the new European Medicines Agency's (EMA) location will not be known until November, EMA on Friday said again that it's anticipating heavy staff losses which will not only challenge its operability but "could also result in a major deficit in its budget," according to highlights published Friday from a management board meeting this month. The comments follow the agency saying last week that it could lose between 19% and 94% of its staff depending on whic...
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    Study Finds FDA Action on Unapproved Drugs Led to Higher Prices, Longer Shortages

    A new study finds that the US Food and Drug Administration's (FDA) 2006 initiative to get manufacturers selling unapproved drugs to submit the drugs for approval or remove them from the market led to higher prices and longer shortages for those drugs. Background Today, drugs must be reviewed by FDA for safety and efficacy or in some cases conform to an over-the-counter (OTC) monograph before they can be marketed in the US. However, in the years between the 1938 Food, D...
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    Canada to Require Drugmakers to Publicly Disclose Drug Shortages

    Beginning on Tuesday, 14 March, amendments to Canada’s Food and Drug Regulations will come into force making it mandatory for drug authorization holders to publicly report drug shortages and discontinuations to two websites, DrugShortagesCanada.ca and PenuriesDeMedicamentsCanada.ca. “As soon as a market authorization holder knows that it will take longer than 20 days to supply a drug to meet expected patient volumes on an ongoing basis, they will report this as a...
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    GAO: FDA's Ability to Monitor Drug Shortages Remains a Concern

    The US Food and Drug Administration's (FDA) oversight of medical products remains a high-risk area for the federal government, particularly with regard to the agency's oversight of drug shortages, according to a report from the Government Accountability Office (GAO) released Wednesday. Despite commitment from FDA leadership to improve drug availability, GAO says it no longer considers FDA's action plan to be effective. As a result, GAO has downgraded its assessment of F...
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    GAO on Drug Shortages: FDA’s Prioritization of Generic Injectable ANDAs is Helping

    As the number of new drug shortages has generally decreased since 2011, the US Government Accountability Office (GAO) said that although it cannot establish a causal link, the US Food and Drug Administration’s (FDA) prioritization of reviewing hundreds of applications and supplements during the time period GAO examined helped address some of those shortages. New drug shortages peaked in 2011, with 257 reported, GAO says in a recently released report, though that number ...
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    WHO Offers New Plan to Limit Drug Shortages

    The World Health Organization (WHO) released a new report this week on ways to address global drug shortages, which are increasing in frequency, particularly for old, off-patent or difficult to formulate treatments. Difficulties in acquiring raw materials, manufacturing problems, barriers to competition, business decisions, the impact of new technologies, expensive medicines and fragmented markets were all listed as reasons for new drug shortages based on studies in seve...
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    European Regulatory Roundup: EMA Looks to Harmonize Definition of Drug Shortage (28 January 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Calls for Harmonized Definition of Medicine Shortages Following Industry Consultation The European Medicines Agency (EMA) has called for the establishment of a harmonized definition of a medicine shortage after meeting with the industry to discuss the development of proactive approaches to preventing shortages in supply. Officials at EMA left the meeting with a strong b...