• Regulatory NewsRegulatory News

    US sues Teva over Copaxone co-pay assistance scheme

    The US Department of Justice (DOJ) on Tuesday announced it has filed a False Claims Act complaint against Teva Pharmaceuticals USA and Teva Neuroscience, alleging the company violated anti-kickback rules by coordinating with two patient assistance charities and a specialty pharmacy to cover Medicare co-pays for its multiple sclerosis drug Copaxone (glatiramer acetate).   “The government’s complaint today alleges that Teva used ostensibly independent charitable founda...
  • Regulatory NewsRegulatory News

    FDA Warns Korean OTC Drugmaker Using Noncompliant Contract Manufacturer

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Seoul, South Korea-based over-the-counter (OTC) drug manufacturer Seindni Co. for current good manufacturing practice (CGMP) violations and labeling concerns. The warning letter notes that the firm "lacks an adequate quality unit" and uses contract manufacturers for its OTC drugs distributed to the US, but during FDA’s inspection, Seindni "confirmed that your contract manufactur...
  • Feature ArticlesFeature Articles

    Evolution of Advertising and Promotion Review Systems

    This article addresses the evolution of review systems used for advertising and promotion materials. Promotional review and approval, at its root, is designed to ensure all marketing and sales materials for pharmaceuticals are compliant with established legal, regulatory and medical standards, as well as company policies and procedures. Pharmaceutical companies employ cross-functional teams applying standard principles of education and training and good judgment to eva...
  • Regulatory NewsRegulatory News

    UK's MHRA Puts New Restrictions on Popular Painkiller

    A widely used over-the-counter painkiller has been reclassified as a prescription-only medicine (POM) by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). In a press release on 14 January 2015, MHRA announced that patients will now need a prescription to purchase diclofenac oral tablets. The agency cited concerns over “increased risk of serious cardiac side effects in some patients,” which is worsened by long-term or high-dose use. The decision to re...
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    US Government Immunizes Future Manufacturers of Ebola Vaccines from Legal Liability

    The US Department of Health and Human Services (DHHS) is providing a gift to manufacturers of prospective vaccines meant to protect patients against the Ebola virus: Protection from legal liability. In an announcement in the 9 December 2014 edition of the Federal Register , DHHS said it was issuing a new declaration that would "provide liability protection for activities related to Ebola virus disease vaccines consistent with the terms of the declaration." Protection f...
  • 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...
  • In Notable Shift, DOJ to Treat Manufacturing Regulations as 'Top Area of Focus' in 2013

    In a notable shift, the US Department of Justice (DOJ) is has announced that current good manufacturing practices (CGMPs) will be one of the agency's "top areas of focus" in the coming year, opening up new areas of uncertainty for those involved in compliance and regulatory activities for the pharmaceutical industry. In remarks made at the Pharmaceutical Compliance Congress (PCC) on 29 January 2012, Maame Ewusi-Mensah Frimpong, deputy assistant attorney general for DOJ...
  • FDA Scores Legal Victory Against Whistleblowing Case as Lawsuit Continues

    US medical device regulators scored a minor legal victory on 9 November 2012, prevailing at least temporarily against the National Whistleblower Center (NWC), which is representing several current and former employees of the US Food and Drug Administration (FDA) in a lawsuit alleging the agency violated their rights to privacy by engaging in surreptitious surveillance against them. NWC has been fighting FDA in the court system to obtain documents about the case, and ...
  • Feature ArticlesFeature Articles

    Orange Book Listings Lesson: An overly broad use code may lead to legal challenges

    The US court system has been busy recently with issues affecting the pharmaceutical industry, including a number of cases involving the Hatch-Waxman Act. On 17 April 2012, the Supreme Court issued a unanimous decision in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S marking the first Abbreviated New Drug Application (ANDA) case decided by the high court since the passage of the act in 1984. The Supreme Court has a long history of overturning Federal C...
  • Report: As Pharma Goes Global, So Do Charges of Corruption

    • 29 February 2012
    A report by Reuters has found that increasingly global pharmaceutical companies are running up against many of the same charges of influence peddling and corruption abroad that they once faced at home. The charges could affect more than just the companies' reputations. "In recent years, Big Pharma has forked out billions of dollars to settle scandals involving improper promotion of medicines in the United States.  Now bribes paid to foreign doctors and other st...
  • Obama Administration, Plaintiffs File PPACA Briefs

    The US Department of Justice (DOJ) and a group of 26 states ("state petitioners") both filed briefs with the Supreme Court of the United States (SCOTUS) on Friday, 6 January outlining their respective arguments regarding the Patient Protection and Affordable Care Act's (PPACA) constitutionality and the severability of certain components of the law. The DOJ brief focuses on the question of whether or not "the minimum coverage provision is a valid exercise of Congress...