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  • Shortages Ongoing and Import Approach in Legal Jeopardy, FDA Turns to Expedited Approvals

    Despite the US Food and Drug Administration's (FDA) ongoing efforts, the problem of drug shortages is persisting with a stubborn tenacity, particularly in several high-need areas. But with its existing method of alleviating drug shortages in legal jeopardy, FDA now seems to be adopting a more permanent tactic to confronting some shortages: full and expedited approvals. Background Drug shortages emerged as a major issue in 2011 and 2012, with many generic sterile injecta...
  • FDA Loses Major Case Testing its Enforcement Discretion Authority

    The US Food and Drug Administration (FDA) has a complicated history with sodium thiopental, a drug notoriously used as part of a multi-drug cocktail administered to prisoners condemned to death. And complicating the history further is a new ruling by the DC Court of Appeals, which today ruled that the agency may not exercise "enforcement discretion" to allow the drug into the country. Background In recent years, death penalty opponents have been using a deep understandi...
  • Anvisa Proposes Mandatory Notice for Manufacturing Suspension

    The Board of Brazil's National Agency for Sanitary Surveillance (Anvisa) has opened a consultation on a proposal that would require companies to provide at least 180 days of advance notice to Anvisa prior to discontinuing, reducing or temporarily suspending the manufacture or importation of essential drugs.  In cases where the action is being taken due to technical reasons that could impact drug quality, safety and/or efficacy, notice would have to be provided to...
  • Cancer Drug Returns, and with it FDA's Willingness to Go After its Manufacturer

    Earlier this week, the US Food and Drug Administration (FDA) made a quiet but important announcement: Supplies of the drug Doxirubicin Liposomal Injection, a widely used cancer drug that has been experiencing massive shortages since 2011, have been resolved. But with the resolution of that shortage has come something else that has been in short supply in recent months as well: regulatory scrutiny for the drug. Background In late 2011, regulators became aware of mounting...
  • Reform Bill Takes Aim at 'Gray Market' Causes for Drug Shortages

    A prominent congressional Democrat this week announced the reintroduction of a bill that looks to ban the practice of so-called "gray market" drug sales, the practice of which has been partially blamed for causing and exacerbating endemic drug shortages within the US. Background The bill, The Gray Market Drug Reform and Transparency Act of 2013 ( PDF ), is sponsored by Rep. Elijah Cummings (D-MD), who first introduced it in the House of Representatives last year....
  • Senators to Hamburg: Ongoing Shortages of Pediatric Drugs Call for Regulatory Response

    One of the biggest regulatory news stories of 2011 revolved around the issue of drug shortages, the outcome of a multitude of unfortunate circumstances that had the effect of causing many drugs-and in particular sterile injectables, the likes of which are often used to combat cancer-to be either partially or fully unavailable to patients. But a curious thing has happened in the last few months: Media attention about drug shortages is itself in short supply. Senators: Ge...
  • FDA Seeks Industry Input on Regulatory 'Strategic Plan' to Fight Drug Shortages

    It's been more than a year since the US Food and Drug Administration (FDA) started to make a concerted, large-scale and coordinated effort to combat mounting drug shortages. But now, in response to new statutory requirements contained within the FDA Safety and Innovation Act (FDASIA) , the agency is reaching out to the public in the hopes of learning what more it might be able to do. Background The US has been grappling with a series of mounting drug shortages for the ...
  • FDA Approves Generic Doxil to Ease Drug Shortages

    The US Food and Drug Administration (FDA) has announced the approval of a generic version of a critical cancer drug that it has been allowing to be imported for almost a year under a rare exercise of its enforcement discretion intended to alleviate drug shortages. Background In late 2011, regulators became aware of mounting drug shortages they said were caused by several factors, but most notably manufacturing problems found at a number of facilities that made sterile...
  • Ben Venue, FDA Receive Approval for Consent Decree, Potentially Easing Drug Shortages

    The US Food and Drug Administration (FDA) has received approval from a federal judge for a consent decree of permanent injunction between it and Ben Venue Laboratories, a manufacturing facility long in the crosshairs of the agency's enforcement officials. Background The company, a subsidiary of Boehringer Ingelheim, suspended its manufacturing capabilities in 2011 after receiving a string of warning letters from FDA over the maintenance of its current good manufacturing...
  • EU Falsified Medicines Directive Could Result in Drug Shortages

    The European Heads of Medicines Agencies (HMA) has notified the European Commission of its "deep" concern that the implementation of the Falsified Medicines Directive (2011/62/EU) will lead to possible shortages of medicinal products with resulting risks to public health.   The Directive, which goes into effect on 2 July 2013, requires all imported active pharmaceutical ingredients (APIs) to be manufactured in compliance with the standards of good manufacturing pr...
  • Facing Shortages, Greece Bans Export of Drugs

    • 24 October 2012
    Greece is one of many countries, including the US and Canada, currently experiencing shortages of numerous drugs. But unlike other countries, Greece, which is in the midst of an economic crisis, has taken a novel and potentially controversial approach to solving the problem: it will no longer allow the export of pharmaceutical products from the country. Reuters reports the country's shortages are mainly the result of price slashing that the country has been forced ...
  • Exclusive: FDA to Continue Regulatory Exception for Doxil Substitute

    The US Food and Drug Administration (FDA) plans to continue to allow a substitute for the anti-cancer drug Doxil, manufactured by Johnson & Johnson subsidiary Ben Venue Laboratories, into the country in the near future despite Ben Venue's 17 October announcement that it has resumed production at its Bedford, Ohio facility. Ben Venue suspended the majority of manufacturing activities at its Bedford plant in November 2011 after inspectors from FDA identified a series o...