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  • Regulatory NewsRegulatory News

    FDA Finalizes Six-Month Drug Shortage Notice Regulation

    A regulation proposed by the US Food and Drug Administration (FDA) in 2013 will take effect on 8 September, requiring drug and biologics manufacturers to notify the agency in advance of impending drug shortages. Background In 2011, after several years of worsening drug shortages, the Obama Administration issued Executive Order 13588 – Regarding Prescription Drug Shortages calling for measures to improve the response to drug shortages through stronger notification re...
  • Regulatory NewsRegulatory News

    Government Report Slams DEA for Oversight of Drug Production Quota System

    Shortages of some pharmaceutical products could be alleviated if the Drug Enforcement Administration (DEA) coordinated its efforts to control the supply of some drugs more closely with the US Food and Drug Administration (FDA), a new government report has found. Background In the US, drug products are primarily overseen by two federal agencies: FDA and DEA. The former regulates drugs in accordance with their efficacy, safety and quality. For example, FDA might approve a...
  • Regulatory NewsRegulatory News

    FDA Takes its Fight Against Drug Shortages to the App Store

    Drug shortages have been something of an endemic problem in the US for the last several years. For healthcare providers, it can be difficult to tell when a drug is in stock or experiencing a short- or long-term shortage. Now a new mobile application developed by the US Food and Drug Administration (FDA) is hoping to change that. Background FDA's struggles with drug shortages first emerged in 2011 and 2012, when many generic sterile injectable drugs began to experience s...
  • Regulatory NewsRegulatory News

    Mirroring International Efforts, Canada Escalates Fight Against Drug Shortages

    The Canadian Government will soon release new regulations on drug shortage reporting, it has announced . The regulations will require companies to report drug shortages on a new, independently run website. Background Drug shortages occur when there is not enough of a product to meet the needs of patients. Due to the complexity of the supply chain for drugs, shortages can occur for a variety of reasons, including manufacturing and distribution issues or unforeseen spike...
  • Regulatory NewsRegulatory News

    European Industry Group Calls for Drug Shortage Reporting Standards

    A group of four pharmaceutical industry associations in Europe is proposing a set of guidelines meant to help European National Competent Authorities (NCAs) and the European Medicines Agency (EMA) alleviate drug shortages through better communication. In its report, the group recommends a set of harmonized standards for how drug shortages caused by quality or manufacturing issues are communicated to relevant authorities. Background Currently, marketing authorization ...
  • Facing Dire Shortage of IV Saline, FDA Again Turns to Enforcement Discretion Approach

    In the face of mounting concerns about a shortage of intravenous saline solutions, the US Food and Drug Administration (FDA) announced it is once again utilizing an uncommon regulatory mechanism to ease the shortage-a mechanism no longer on the strongest of legal footings. Background Drug shortages have been an ongoing problem in the US since at least 2011, and have been blamed on a number of causes, including quality problems at manufacturing facilities, overly aggr...
  • Brazil to Require Notice One Year Prior to Drug Withdrawal

    Drug manufacturers must now provide a year's notice to Brazil's national regulator, Anvisa, prior to withdrawing a drug from the market if that withdrawal might lead to a shortage of the drug.  The objective of the new mandate, approved on 25 March 2014, is to reduce the potential impact of any drug shortage on the patient population for which the drug is indicated. The 12-month notice mandate also covers situations where the intent is merely to reduce the level...
  • GAO Says FDA Doing (Almost) All It Can to Alleviate Drug Shortages

    The US Government Accountability Office (GAO) has released a follow-up report on the national problem of drug shortages, lauding the US Food and Drug Administration (FDA) for making efforts to alleviate drug shortages. Background "The number of drug shortages remains high," begins the report, released on 10 February 2014. While GAO noted significant progress in confronting new drug shortages in 2013 compared to 2012, its data portrayed the stubbornness with which some o...
  • BIO Argues Changes Needed to FDA's Drug Shortage Rule to Account for Vaccines

    Should vaccines be considered under the US Food and Drug Administration's (FDA) recent drug shortages rule? No, argues the Biotechnology Industry Organization (BIO), which explained in a recent letter to FDA that the Centers for Disease Control and Prevention (CDC) has been able to adequately handle shortages of vaccines on its own for at least the last decade. Background Drug shortages emerged as a major issue in 2011 and 2012, with many generic sterile injectable drug...
  • Could FDA's New Drug Shortage Rule Make Shortages Worse? Generic Drug Industry Says 'Yes'

    The US' generic pharmaceutical manufacturing industry is taking issue with one of the core components of a new drug shortage strategy laid out by the US Food and Drug Administration (FDA), calling it well-intentioned but infeasible and even harmful in some cases. Background Drug shortages emerged as a major issue in 2011 and 2012, with many generic sterile injectable drugs experiencing supply shortages. Investigations into the matter brought to light a number of reasons...
  • Reasons for Shortage Unclear, House Members Ask FDA to Consider Importing Alternatives

    The US Food and Drug Administration (FDA) may have recently unveiled a new rule intended to facilitate more coherent responses to ongoing drug shortages, but some legislators are now hunting for answers about one shortage of a drug used to treat childhood cancer patients, saying neither the agency nor the drug's manufacturer have been able to provide answers thus far. Background As regular readers of Focus well know, drug shortages have been an endemic problem in the ...
  • EMA Launches Drug Shortage Registry as Part of 'Short Term' Action Plan

    Even outside of the United States, drug shortages are proving to be a stubborn problem, and for reasons similar to those causing chronic shortages of essential medications in the US. Background In the US, regulators and analysts say no one problem is to blame for ongoing drug shortages, which have hit sterile injectable drugs particularly hard in recent years. Instead, they say, five problems share portions of blame. Among them: Some gray market pharmacies  have...