• Wyeth Agrees to Pay $491 Million to Resolve Federal Off-Label Marketing Charges

    The US Department of Justice (DOJ) has announced that Wyeth Pharmaceuticals, now a subsidiary of Pfizer, has agreed to pay $491 million to settle allegations that it had unlawfully marketed the drug Rapamune, a kidney transplant drug, for unapproved uses in other organ transplant populations. Under the Federal Food, Drug and Cosmetic Act (FD&C Act) , companies are only permitted to market a drug product for which they have received approval, and then are only permit...
  • In Major Reversal, EMA Ordered by EU Court to Halt Clinical Trials Transparency Initiative

    Plans by the European Medicines Agency (EMA) to make clinical and non-clinical data available to the public have been dramatically put on hold after the General Court of the EU today issued an interim order that the agency is not to publish the documents until a final order is passed down. EMA has been moving toward a policy of transparency since at least November 2010, when it first announced its intent to eventually publish all research data provided to it in support o...
  • Pharmaceutical Company's Regulatory Missteps Tempt Shareholder Legal Action

    • 18 March 2013
    Generics pharmaceutical manufacturer Impax Laboratories hasn't had an easy last two weeks. On 4 March 2013, it announced that the US Food and Drug Administration (FDA) had, after conducting an inspection at its California Facility, determined that the facility had 12 deficiencies, and issued it a Form 483 . Those deficiencies sent the firm's shares plunging . Then, on 15 March 2013, FDA announced it would withdraw approval for the company's generic equivalent of bupro...
  • Court Rules that Consent Decree Overrules Company's Claims of FDA Inspector Malfeasance

    The Sixth Circuit Court of Appeals has ruled against a company attempting to sue a compliance officer of the US Food and Drug Administration (FDA), saying the supplement manufacturer has forfeited the right to sue as the result of a consent decree it entered into with the agency in 2009. The court's decision, authored by Judge Jeffery Sutton, at times adopts a tongue-in-cheek style to explain the facts of the case. LG Sciences had promised that its product would prod...
  • 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 ...
  • J&J Settles Court Cases In Advance of Testimony by Former FDA Commissioner

    • 05 October 2012
    Even after stepping down from his position as head of the US Food and Drug Administration (FDA), former Commissioner David Kessler seems to be having a strong impact on the fortunes of some pharmaceutical companies. Kessler had been called on to testify on behalf of litigants in a series of trials set to be heard in a Pennsylvania court room the week of 8 October regarding Johnson & Johnson's marketing of its antipsychotic drug Risperdal (risperidone). Litigants have...
  • FTC Seeks Supreme Court's Intervention in 'Pay-for-Delay' Cases

    The US Federal Trade Commission (FTC) is calling on the US Supreme Court to review a so-called "pay-for-delay" case concerning generic and branded versions of AndroGel , a topical testosterone treatment, a new escalation in the agency's long-standing efforts to curb the practice. Pay-for-delay cases involve the manufacturer of a patented, innovative medicine paying its potential competitors not to manufacture generic versions of that medicine. FTC has consistently attac...
  • Department of Justice Seeks Dismissal of Whistleblowers' Case Against FDA

    The Department of Justice (DOJ) has filed a motion to dismiss a lawsuit brought against the US Food and Drug Administration (FDA) by several current and former agency employees after FDA allegedly spied on their whistleblowing activities to members of Congress and other oversight agencies. DOJ's motion, filed on 1 October-almost exactly a year after the case was first filed-seeks dismissal based on a "lack of jurisdiction." Bloomberg explains DOJ argues that an...
  • In Ruling Against KV Pharmaceuticals, FDA's Enforcement Discretion Upheld

    A lawsuit filed by KV Pharmaceuticals against the US Food and Drug Administration (FDA) was thrown out of court on 6 September 2012 after a judge ruled the company could not challenge activities falling under FDA's enforcement discretion. KV filed its suit against FDA in July 2012 over FDA's allowance of compounded versions of its anti-premature pregnancy drug Makena (17P / hydroxyprogesterone caproate injection) to remain on the market. A Long-Running Saga The long...
  • J&J to Pay Millions in Marketing Lawsuit

    • 31 August 2012
    Johnson and Johnson will pay $181 million to settle a lawsuit about how it marketed an antipsychotic drug, but the company denies any wrongdoing, according to a PMLive report. The suit claims the drug, Risperdal, was promoted for uses not approved by the U.S. Food and Drug Administration and also made false claims about its effects. The payment will be distributed to 36 states and the District of Columbia, the report said. This is the latest round of problems J&J ha...
  • Blaming FDA's Enforcement Discretion, Company Files for Bankruptcy

    Missouri-based KV Pharmaceutical , the manufacturer of pre-term birth prevention compound Makena (hydroprogesterone caproate injection), has filed for bankruptcy in federal court citing the US Food and Drug Administration's (FDA) "lack of enforcement" of the company's marketing exclusivity rights, reports Bloomberg . The filing could mark a final chapter in a long-running and often controversial saga between KV and FDA. The entire matter stems FDA's 2011 approva...
  • FDA: Challenge to Enforcement Discretion Without Standing, Merit

    Are the US Food and Drug Administration's (FDA) discretionary enforcement actions beyond industry reproach? In a recent court filing, lawyers for the US regulators argue they are, especially as discretionary actions-and statements of intended actions-relate to a specific court case filed by Minneapolis-based KV Pharmaceutical. In a July filing before the US District Court in DC , KV argued FDA had used enforcement discretion to "unlawfully" promote competition to its dr...