• Following FDA, EMA Launches Review of Emergency Contraceptive Effectiveness

    EU regulators have announced they are initiating a review of emergency contraceptives like Teva's Plan B One-Step following reports that the drug may lose effectiveness in women who are overweight or obese. Background In November 2013, Mother Jones broke the news that HRA Pharma, manufacturer of the emergency contraceptive Norlevo, was updating its packaging to reflect new evidence that the drug begins to lose effectiveness in overweight women, and may lose all effect...
  • After Confusing Approval Process, FDA Confirms Teva's Plan B One-Step will get Exclusive Rights

    The US Food and Drug Administration (FDA) has given Teva Women's Health, the manufacturer of the controversial Plan B One-Step (levonorgestrel) drug that recently won over-the-counter status after years of contentious legal battles, three years of market exclusivity during which time no generic products may be marketed using the OTC indication, FDA has announced. Background The development, first announced by The Boston Globe , was found within FDA's Orange Book ,...
  • One-Step, Step One: FDA Finalizes Approval of Teva's Plan B One-Step for Women of All Ages

    The US Food and Drug Administration (FDA) has finally announced the approval of Teva Women's Health's Plan B One-Step (levonorgestrel) for women of all ages, over the counter (OTC) and without a prescription, bringing to a close a case that has wound through the US' legal and regulatory systems for years. Background: The Story so Far… FDA initially approved Teva's proposal to make Plan B One-Step available OTC in December 2011, but was immediately overturned on 7...
  • FDA Concedes Plan B Case, Will Make Single-Pill Version Available to All Consumers

    In an unexpected reversal, the US Department of Justice (DOJ)-acting on behalf of the US Food and Drug Administration (FDA)-has announced that it will allow Teva Women's Health's Plan B One-Step (levonorgestrel) to be marketed over the counter (OTC) without age or point-of-sale restrictions, in effect dropping its appeal of an order issued earlier this year by Judge Edward Korman. Background FDA initially approved Teva's proposal to make Plan B One-Step available OTC in...
  • False Statements on Facebook Regarding FDA-Regulated Product Lead to Jail Time for Iowa Man

    Rarely does one person influence how the US Food and Drug Administration (FDA) looks at a company, but every so often one person comes along and-for better or worse-changes the agency's perspective. This article is about the latter of those two possibilities. Background An example of the former may well be Dinesh Thakur, who blew the whistle on deficient practices at Ranbaxy, practices for which the company has now paid hundreds of millions of dollars. But if that's ...
  • Government Outlines Case on 'Plan B' Appeal, Argues Violations of Proper Process

    The US Food and Drug Administration (FDA) on Friday filed a motion to stay an earlier decision by a New York circuit court judge that would have required it to approve Teva Women's Health's Plan B One Step, an emergency contraceptive pill that has long been at the center of legal battles between the agency and women's health groups. The little-noticed appeal, made right before a holiday weekend on 24 May 2013, serves to outline the agency's case in support of a motion to...
  • Judge Demolishes FDA's Plan B Appeal, Claims Agency Actions Undermining Public Confidence

    In a scathing ruling issued on 10 May 2013, US District Court Judge Edward Korman has ordered the US Food and Drug Administration (FDA) to approve Teva Women's Health's citizen petition to approve its Plan B (levonorgestrel) product for women as young as 10, blasting the regulator for engaging in what he called a "filibuster through the appellate process." Background The court case revolves around a long-running and complicated approval decision made by FDA in December ...
  • FDA Says 'Plan B' Ruling Overstepped Judicial Authority, Endangering Regulatory Process

    Just hours after approving an application from Teva Women's Health allowing the company to market its product over-the-counter (OTC) to women as young as 15 years of age, the US Food and Drug Administration (FDA)-by way of the US Department of Justice-filed an appeal in the US District Court of New York seeking to overturn an earlier ruling that ordered the agency to approve the drugs for girls as young as 10 years of age. Background In December 2011, Kathleen Sebelius,...
  • FDA Approves Plan B for Additional Ages after Teva Provides New Data to Placate 'Political' Concerns

    In a major announcement made late Tuesday, the US Food and Drug Administration (FDA) announced that it had expanded the approved indications for Plan B One Step, a birth control medication manufactured by Teva Women's Health and the subject of ongoing, complex and contentious litigation. Background Teva submitted an application to FDA in 2012 to allow it to market Plan One-Step (levonorgestrel) for use without a prescription to women 15 years of age and older-the same a...
  • UK's NICE Releases Draft Guidance on Diagnosis and Treatment of Hepatitis B

    The UK's cost containment agency, the National Institute for Health and Clinical Excellence (NICE), has issued a draft guideline on the  diagnosis and management of chronic hepatitis B in children, young people and adults , explaining that only pegylated interferon and nucleoside or nucleotide analogues have been cleared for use by the National Health Service (NHS). The guideline, released for consultation on 17 January 2013, also noted that although substantial pr...
  • EMA Releases Draft Guideline on Hepatitis B Vaccines

    The European Medicines Agency (EMA) has released a new guideline to instruct sponsors of clinical trials on best practices for assessing antibody-based products used to prevent the hepatitis B virus. The 2 December 2012 draft guideline, On the Clinical Investigation of Hepatitis B Immunoglobulins , is specifically aimed at vaccines, which EMA explains are an effective method for protecting uninfected, healthy individuals against infection by the hepatitis B virus. T...
  • Final Guidance for Blood Product Testing Released by FDA

    The US Food and Drug Administration (FDA) has released a final guidance regarding the use of nucleic acid tests (NATs) to reduce the transmission of hepatitis B, part of a strategy the agency says it hopes will assist in the screening of blood and plasma donors for the virus. The final guidance comes nearly a year after the agency first released the draft version of the guidance . FDA said it considers Hepatitis B (HBV) NATs to be "necessary to reduce adequately and a...