• Group Sues FDA, Seeking to Compel it to Withdraw Alzheimer's Drug from Market

    Consumer advocacy group Public Citizen has filed a lawsuit against the US Food and Drug Administration (FDA) seeking to compel it to remove a particular dose of the Alzheimer's drug Aricept, which the group alleges is causing dangerous and potentially fatal side effects. The lawsuit stems from a May 2011 Citizen's Petition filed by the group. The letter, addressed to FDA Commissioner Margaret Hamburg, calls for the 23 mg dose of Eisai's drug Aricept to be removed bec...
  • FDA Wants Post-Approval Studies to Address Broader Public Health Needs

    The US Food and Drug Administration (FDA) is preparing a workshop to focus on the design and appraisal of studies conducted after the approval of a product to obtain further evidence of its safety or effectiveness. The studies, otherwise known as post-approval studies (PAS), are often used when there are outstanding questions regarding a product. Many products that receive accelerated approval from US regulators, for instance, must conduct PAS because their initial app...
  • EMA Opens Consultation on Product Information Changes

    The European Medicines Agency (EMA) has opened a consultation on the information changes to the summary of product characteristics (SmPC) and package leaflets mandated by the new European pharmacovigilance law.   The legislation requires the addition of information to the SmPC, which is aimed at healthcare professionals, and to the package leaflet, which is aimed at patients and consumers. This information is to include: a statement and a black symbol for m...
  • Report: EMA to Make Public All Clinical Trials Data

    The European Medicines Agency (EMA) is set to unveil a measure to substantially increase the transparency of clinical trials data collected by the European regulator as part of its medicines approval process, reports Reuters . The new transparency measures would vault the agency ahead of its US counterpart, the US Food and Drug Administration, which currently does not require clinical trials data to be made public, though the existence of the trials themselves are poste...
  • Australia Proposes Changes to How Sponsors Amend Approved Prescription Applications

    Australia's Therapeutic Goods Administration (TGA) announced on 12 June the impending release of proposed changes to how sponsors of registered prescription medications can make "minor variations" to the medicine's entry in the Australian Register of Therapeutic Goods (ARTG). TGA said the changes typically fall under one of four categories: corrections to the entry, a safety-related changes, "self-assessable" quality-related changes or Category 3 quality-level changes. T...
  • Brazil: Meeting to Discuss New Criteria for Therapeutic Indications

    The Board of Anvisa, the national regulatory authority of Brazil, is scheduled to review new regulations governing the format of "non-print" instructions for use of health products and the criteria for a therapeutic indication at its next public meeting. The Board will also receive a report by the Chief Executive Officer of Anvisa, Dirceu Barbano, on the international meeting of national regulators held in Geneva on 18 May that was organized by the agency on the topic of...
  • France: HAS Posts Overview of HTA Public Consultations

    France's Haute Autorité de Santé (HAS) has posted an  overview of public consultations  undertaken by the agency over the last few years, as well as an international survey of similar agencies in other countries such as the UK's National Institute for Health and Clinical Excellence (NICE). The document release is a first step in the preparation of a methodological guide for public participation in the development of health technology assessments. ...
  • Group Calls for Changes to User Fee Bill After Transparency Concerns Emerge

    A group of 20 public interest organizations has written the US Congress to express their displeasure with a measure which would purportedly allow the US Food and Drug Administration (FDA) to hide health and safety inspection information from the public. The group is most concerned about Section 812 of the FDA Reform Act (FDARA) , which they say "allows the FDA to deny the public access to information relating to drugs obtained from a federal, state, local or foreign gov...
  • Public Citizen to FDA: Diabetes Drug Unsafe, Should Be Pulled

    The watchdog group Public Citizen is calling on the US Food and Drug Administration (FDA) to yank Novo Nordisk's diabetes drug Victoza (liraglutide) off the market for safety risks it says "outweigh any documented clinical benefits." After being approved, "the watchdog group says a review of the FDA adverse event database found 200 patients were diagnosed with acute pancreatitis during the first 17 months that Victoza was available, suggesting a larger number of [thyroid...
  • Public Health Service Employees Not Subject to Whistleblower Protections

    The US Food and Drug Administration (FDA) counts among its ranks hundreds of Public Health Service (PHS) employees-members of a uniformed service charged with upholding and promoting public health and advancing public health science. While these employees are easily recognizable as a result of their military service uniforms, the federal government does not recognize a basic protection for these employees: whistleblowing protections. A Washington Post report details h...
  • FDA Seeks Input on Next ICH Steering Committee Meeting

    The US Food and Drug Administration (FDA) is seeking input on the next meeting of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) meeting to be held in Fukuoka, Japan. FDA currently participates in the ICH by way of its Centers for Drug Evaluation and Research and Biologics Evaluation and Research. It is looking for public participation in the topics to be discussed at the upcoming meeti...
  • FDA Releases New Safety Communication Strategy

    The US Food and Drug Administration (FDA) released draft guidance on 8 March on how it intends to communicate with the public about drug safety issues, including important topics and emerging information. "The revised guidance describes the Center for Drug Evaluation and Research's (CDER's) single, standardized format for electronic drug safety communications about marketed drugs and provides information about the Center for Biologics Evaluation and Research's (CBER's) s...