• With Regulatory Risks High, Companies Purchasing Higher Insurance Limits for Corporate Officers

    • 16 March 2012
    Companies concerned about their corporate officers' exposure to regulatory claims are purchasing ever-higher limits on existing insurance policies, reports The Wall Street Journal ( WSJ ). Many insurance policies do not cover the cost of legal settlements for regulatory claims, which leaves many of the top brass at companies exposed to "a highly litigious environment," according to one source interviewed by the WSJ . "The policies, generally called "D&O liability...
  • AstraZeneca Sues FDA to Halt Generic Seroquel

    Pharmaceutical manufacturer AstraZeneca filed a lawsuit on 13 March seeking an injunction against the US Food and Drug Administration (FDA) to bar it from allowing generic versions of its blockbuster antipsychotic drug Seroquel to be marketed in the US. FDA denied two Citizen Petitions from AstraZeneca on 9 March that requested FDA delay market entry for any generic products not containing the exact warnings contained on the reference listed drug (RLD). FDA said in its...
  • J&J Faces Larger Fine as DOJ Rejects $1B Risperdal Settlement

    Johnson & Johnson's tentative $1 billion settlement with the US Department of Justice over allegations of improper marketing of its schizophrenia drug Risperdal was rejected on 12 March by federal prosecutors, reports The Wall Street Journal . Sources close to the matter told  Bloomberg News  federal prosecutors are demanding an additional $800 million to resolve the civil claims in the government's lawsuit. The charges originate from a US investigation i...
  • Lawsuit Against Genzyme Seeks Damages for Fabrazyme Shortages

    • 12 March 2012
    A lawsuit filed by an Idaho woman claims negligence on the part of Genzyme, now a subsidiary of Sanofi, led to persistent drug shortages and consequently the death of her husband. Shortages of Fabrazyme, used to treat Fabry Disease, started in 2009 when viral contamination was discovered at a Genzyme manufacturing facility. Shortages were further exacerbated when additional contamination was found by the US Food and Drug Administration later in 2009, leading to a situati...
  • California Supreme Court Looks to Take Up 'Pay for Delay' Case

    The California Supreme Court is set to review a case on so-called 'pay for delay' settlements that see pharmaceutical manufacturers pay generic manufacturers to secure additional months of market exclusivity for their products. The court will review a decade-old class-action lawsuit against Bayer over its pay for delay settlement to Barr Laboratories. Barr was reportedly planning to sell a generic version of Bayer's antibiotic, Cipro (ciprofloxacin). The lawsuit alleges...
  • Inmates Sue Agency to Stop Import of Drugs

    Death row inmates incarcerated in Tennessee, Arizona and California argued on 9 February that the US Food and Drug Administration (FDA) is breaking the law by allowing the importation of sodium thiopental -an anesthetic drug commonly used in a cocktail of execution drugs-after its manufacturer halted domestic production of the drug in 2011. The inmates contend that FDA does not have the authority to allow the drug to be imported because the drug product does not have ma...
  • Lawsuit Seeks to Overturn Sebelius' Decision, Allow Wider 'Morning-After-Pill' Access

    A coalition led by the Center for Reproductive Rights (CRR) on 8 February sought to overturn a decision made by US Department of Health and Human Services (DHHS) Secretary Kathleen Sebelius. The group appeared before Judge Edward Korman of the US District Court in Brooklyn, NY, to petition the court to re-open a lawsuit that would allow those under the age of 17 to access the "morning-after-pill" levonorgestrel without a doctor's prescription. While the US Food and Dru...
  • Hamburg Discusses Plan B Decision, Lawsuit Against Agency

    • 07 February 2012
    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg gave a lengthy interview to Forum host Michael Krasney on a number of controversial topics during a 6 February interview, including a recent whistleblower lawsuit and the FDA's overruled decision regarding Plan B One-Step. Hamburg discussed the controversial Plan B One-Step decision made last month by the agency. FDA had determined that the pill, used to prevent pregnancy by preventing ovulation or f...