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  • Regulatory NewsRegulatory News

    Six Lawsuits Target AbbVie’s Humira and its Patent Thicket

    The city of Baltimore, the largest grocery-worker union in New York and at least four other health plans have filed lawsuits against AbbVie over the past several weeks, alleging the Chicago-based company’s blockbuster Humira (adalimumab) should already have biosimilar competition in the US. One of the lawsuits, brought on by UFCW Local 1500 Welfare Fund, the New York grocery-worker union, argues that AbbVie should be held accountable for its thicket of patents and recen...
  • Regulatory NewsRegulatory News

    US Intervenes in False Claims Suit Against Alere, Arriva Medical

    The US Department of Justice (DOJ) announced Tuesday that federal prosecutors intervened in a lawsuit under the False Claims Act whistleblower provisions against a former supplier of blood glucose monitoring supplies. The case alleges that Arriva Medical and its parent company Alere “submitted or caused false claims to the Medicare program for medically unnecessary glucometers and paid kickbacks to Medicare beneficiaries in the form of free glucometers and copayment w...
  • Regulatory NewsRegulatory News

    Sandoz Petitions Supreme Court to Rule on Biosimilars

    Novartis' Sandoz has called on the US Supreme Court to review a lower court ruling that found biosimilar makers must wait an additional six months after US Food and Drug Administration (FDA) approval before they can bring their product to market. The petition for the Supreme Court’s review deals with Sandoz’s Zarxio (filgrastim-sndz), which came to market as a biosimilar version of Amgen’s Neupogen (fligrastim). Although FDA approved Zarxio in March 2015 as the first bio...
  • Regulatory NewsRegulatory News

    Group Sues FDA, Seeking Access to Ebola Information

    A battle over regulatory documents has led a libertarian-leaning think tank, The Goldwater Institute, to sue the US Food and Drug Administration (FDA) in the hopes of compelling the agency to hand over information related to how several US citizens received drugs to treat the Ebola virus. Background In August 2014, the American public became fixated on an outbreak of Ebola in West Africa after two US missionaries, Dr. Kent Brantley and Nancy Writebol, became infected wi...
  • Regulatory NewsRegulatory News

    Generic Drug Industry Threatens FDA With Lawsuit Over Drug Labeling Proposal

    The generic pharmaceutical industry's most prominent trade body, the Generic Pharmaceutical Association (GPhA), is threatening to sue the US Food and Drug Administration (FDA) if the agency finalizes a change in its labeling regulations that would make it easier for generic drug companies to update their product's labels in response to adverse events. Background Under the Federal Food, Drug and Cosmetic Act (FD&C Act) , generic drug products must—with minor exceptions—...
  • Regulatory NewsRegulatory News

    Off-Label Use Case on Potential Path to Supreme Court, With Wide-Ranging Implications for FDA

    A debate in Arizona which in part focuses on the authority of the US Food and Drug Administration (FDA) to regulate the use of drug products may soon find its way before the Supreme Court, with major implications for a wide range of products. Background The matter in question concerns a federal court case, Planned Parenthood v. Humble , challenging a 2012 Arizona law which makes it illegal to use the drug RU-486 (mifepristone) for uses not explicitly approved by FDA....
  • Mylan Sues FDA, Seeking Earlier Approval for Generic Celebrex

    Generic pharmaceutical manufacturer Mylan says it plans to sue the US Food and Drug Administration (FDA) after regulators declined to grant 180 days of market exclusivity for its generic version of Pfizer's Celebrex (celecoxib). Background Under the 1984 Hatch-Waxman Act , companies are allowed to file for approval for a generic version of a drug once the original product's patent and market-based exclusivity provisions end. To incentivize companies to challenge the va...
  • AbbVie Withdraws Legal Challenge Against EMA Regulatory Transparency Policy

    EU regulators have announced that one of two major legal challenges to a policy that would make public the results of many clinical trials used to support approval of already-approved drug products has been withdrawn. Background In recent years, a growing number of voices have been clamoring for greater transparency of clinical trials results, especially after some companies were found to have hidden unfavorable data regarding the safety of drugs which were later recall...
  • Hawaii Sues BMS, Sanofi Over Genetic Limitations of Plavix

    The US is a large and diverse country, with more than 310 million citizens spanning more than 3.7 million square miles. But in a lawsuit filed on 19 March 2014, the attorney general of Hawaii said two major drug manufacturers failed to take that diversity into account when marketing their drug, Plavix. Background Plavix (clopidogrel bisulfate) is a blood thinner approved by the US Food and Drug Administration (FDA) in 1998 to treat patients with peripheral arterial dise...
  • Advocacy Group Pries Additional Details from FDA About Approval of AIDS Drug Truvada

    The AIDS Healthcare Foundation (AHF), a DC-based advocacy group, has won yet another legal battle against the US Food and Drug Administration (FDA), forcing it to turn over significant documents related to the approval of Gilead Science's pre-exposure prophylaxis (PrEP) drug Truvada (tenofovir/ emtricitabine). Background The legal victory for AHF is its second in the last year. In 2013, FDA announced it would expedite the review of Truvada based on its expected cl...
  • After Trio of Disastrous Inspections, Company Enters into Consent Decree with FDA, DOJ

    In February 2013, the US Department of Justice (DOJ) announced it would be making the enforcement of the US Food and Drug Administration's (FDA) current good manufacturing practices (CGMPs) one of its "top areas of focus" for 2013. And while the ultimate effects of that effort have yet to be realized, at least one pharmaceutical manufacturer is now feeling the brunt of DOJ's enforcement activities. Bad Inspections In a 26 August 2013 announcement, DOJ said it has file...
  • AIDS Group Wins Bid to Obtain 'Confidential' Data Analysis, Summaries About HIV Drug from FDA

    When it comes to patient groups interacting with the US Food and Drug Administration (FDA), some relationships are more adversarial than others. And while plenty of patient groups have their problems with FDA-its regulatory processes, its standards, its conclusions and its approvals-few do anything to escalate those gripes beyond a letter to the commissioner or a call to their congressperson. And then there's the AIDS Healthcare Foundation (AHF). Background The Washi...