The Learning Portal will be under maintenance Friday, 28 January from 10PM to 12AM. Portal functionality may be unavailable intermittently during this window.
We apologize for any inconvenience caused during this time.

  • Chronic Regulatory Compliance Issues Causing Shortages, Safety Problems

    • 18 October 2012
    Chronic regulatory lapses at manufacturing facilities are exacerbating drug shortages and patient safety issues, claims a new report published in The New York Times . The report chronicles the huge number of issues-some of them particularly egregious-that have occurred in recent years at facilities responsible for manufacturing pharmaceutical products. The problem is especially prominent at facilities that manufacture sterile injectable drugs, which have experienced...
  • WSJ: Johnson & Johnson Looks to Ease Drug Shortages through Shared Manufacturing Plan

    • 09 October 2012
    A long-running drug shortage involving Johnson & Johnson's anti-cancer drug Doxil (doxorubicin) may be on the verge of easing after the company applied to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approval of a new, shared manufacturing method. The root of Doxil's shortages is a " voluntary shutdown " of an Ohio facility run by Ben Venue Laboratories, a contract manufacturer working for J&J, after a November 2011 i...
  • Report: Drug Shortages Abating Thanks to FDA Efforts

    In at least one respect, 2011 was not a banner year for the US Food and Drug Administration (FDA): drug shortages. While the agency managed to approve 35 new drugs, 267 were in short supply at one point during 2011, according to information released by the University of Utah Drug Information Service (DIS). But that trend may be changing for the better, reports NBC News . Compared to the same time in 2011, there have been approximately a third fewer drug shortages ...
  • Brazil: Strike May Prompt Drug Shortages

    [Editor's note: the majority of Brazilian regulatory authorities ended their strike on Monday, 3 September 2012 according to Reuters . Approximately 10% of workers remain on strike.] The Brazilian press is claiming that the ongoing strike of employees at the country's National Health Surveillance Agency, Anvisa, is threatening to create drug shortages throughout the country.   "In the hospitals, concerns have grown over shortages of essential medicines an...
  • Medical Journal Calls for National Approach to Canadian Drug Shortage Crisis

    Pharmacists and patients in Canada are experiencing frequent drug shortages as the result of numerous and complex factors, leading the Canadian Medical Association Journal (CMAJ) to call for a national approach to managing the crisis . Writing in the 20 August edition of CMAJ , Dr. Matthew Stanbrook, deputy editor of CMAJ and Rosemary Killeen, editor-in-chief of the Canadian Pharmacists Journal , explained the shortages are increasing in severity and scope, result...
  • Industry Program Aimed at Preventing Drug Shortages Obtains FTC Approval

    The Federal Trade Commission (FTC) has announced its approval of a proposed plan by the generic pharmaceutical industry to alleviate and hopefully prevent future drug shortages, saying safeguards built into the plan, "Make it unlikely to harm competition." Unlike the US Food and Drug Administration (FDA), FTC is only concerned about the plan's effect on trade-not the quality or safety of a pharmaceutical product. FTC said it was responding to a letter from the Generic...
  • Legislators: Abusive Practices Leading to Drug Shortages, Massive Markups

    • 26 July 2012
    A new investigative report out by a trio of democratic legislators show abusive practices to be rampant in pharmaceutical wholesaling, with re-selling of some drugs contributing heavily to the amount of drug shortages. " Shining Light on the 'Gray Market' ," written by Sen John Rockefeller (D-WV), Sen. Tom Harkin (D-IA) and Rep. Elijiah Cummings (D-MD), comes after hospitals and other healthcare providers had raised concerns about their inability to procure injectable ca...
  • FDA Fires Back at Legislative Critics, Blames Manufacturers for Drug Shortages

    The US Food and Drug Administration (FDA) is seeking to distance itself from a June 2012 report by the House Oversight Committee claiming the regulatory agency is the root cause of drug shortages currently plaguing dozens of pharmaceutical products. The original report, FDA's Contribution to the Drug Shortage Crisis , claimed FDA had "largely sparked" shortages through its increased reliance on facility inspections and monitoring of regulatory compliance activities....
  • UPDATED: Obama Signs FDA User Fee Bill Into Law

    US President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law on 9 July 2012-12 days after the Senate approved the bill and 17 days after the House of Representatives passed the bill. The bill now carries the force of law, though its provisions largely do not come into effect until 1 October 2012. In a statement released by Press Secretary Jay Carney, the White House stated the President had "signed into law" FDASIA , a...
  • DEA to Increase Supply of ADHD, Opioid Ingredients in Light of Shortages

    • 06 July 2012
    The US agency in charge of setting drug production quotas for substances regulated under the Controlled Substances Act (CSA) is proposing a mid-year adjustment in its production quotas for the active pharmaceutical ingredients contained within many attention deficit hyperactive disorder (ADHD) drugs and painkillers in response to growing drug shortages. In a 5 July 2012 Federal Register posting, the US Drug Enforcement Administration (DEA) announced it is looking to ...
  • Government Report Blames Drug Shortages on FDA, Calls for Change in Warning Letter Policy

    • 18 June 2012
    A new report released by the Chair of the House Oversight Committee, Representative Darrell Issa (R-CA), blames the US Food and Drug Administration (FDA) for an "unprecedented" series of dug shortages which has had a particularly pronounced effect on cancer patients. In the report, FDA's Contribution to the Drug Shortage Crisis , Issa claims that while others have attributed the causes of the shortages to a "myriad of factors"-raw materials shortages, market concentrati...
  • Legislators: To Help Alleviate Drug Shortages, Establish Track and Trace Provisions

    • 13 June 2012
    Two Democratic legislators this week sent a letter to members of the Senate's and House of Representatives' healthcare oversight committees detailing the findings of the legislators' investigation into the effects of the so-called "gray market" on prescription drug shortages. In their 11 June letter, Senator Jay Rockefeller (D-WV) and Representative Elijah Cummings (D-MD) said their investigation had "identified significant risks in the US pharmaceutical distribution cha...