• J&J Petition Claims FDA Decision Meant to Ease Drug Shortages Puts Some Future Patients at Risk

    Drug shortages have been a recurring problem in the US thanks to a combination of market factors, regulatory decisions made by the US Food and Drug Administration (FDA) and manufacturing problems experienced by companies. So in 2012, when Johnson & Johnson's oncology drug Doxil (doxorubicin hydrochloride liposome injection, NDA # 050718 ) started experiencing shortages, FDA unveiled an unusual plan . It would allow a similar drug, Lipodox (ANDA # 203263 ), made by ...
  • 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...
  • 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...
  • 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...
  • 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...
  • Nebraska Raises Stakes in Battle With FDA, Won't Surrender Supply of Controversial Drug

    The state of Nebraska, engaged in an ongoing battle with the US Food and Drug Administration (FDA) over its supply of an controversial anesthetic drug used in executions, confirmed it will defy an FDA order to hand over remaining supplies of sodium thiopental, reports The Associated Press. In a statement released 20 April, Nebraska's state attorney general's office said they believed a court order, issued by Federal District Court Judge Richard Leon, was incorrect. Leon...
  • Court Bars FDA from Importing Drug Used in Death Penalty

    A US District Court judge this week barred the US Food and Drug Administration (FDA) from importing an anesthetic drug used in executions, saying FDA's use of enforcement discretion was "callous" and "disappointing," reports Reuters . "The FDA appears to be simply wrapping itself in the flag of law enforcement discretion to justify its authority and masquerade an otherwise seemingly callous indifference to the health consequences of those imminently facing the execution...
  • FDA Fights Cancer Drug Shortages

    • 22 February 2012
    The US Food and Drug Administration (FDA) is taking steps to increase the supply of two important cancer drugs: methotrexate and doxil. CNN's The Chart  blog reported that Doxil will be replaced by Lipodox, a drug that is currently manufactured overseas and has not been approved by FDA. It has been evaluated to ensure that it does not pose any risks to patients. FDA is boosting the supply of methotrexate with the approval of a new manufacturer and the release of...
  • US FDA Importing Unapproved Drugs to Ease Shortages

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg announced at a press conference on 21 February that the agency is working with manufacturers to resolve drug supply shortages of the cancer drugs Doxil (doxorubicin) and methotrexate. Hamburg said the agency is working with domestic and foreign manufacturers to bring supply levels of both drugs back to non-shortage levels, adding that the agency has allowed the import of an unapproved replacement of Dox...