• 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...
  • 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...
  • Pharmaceutical Manufacturer Sues FDA Over Use of Enforcement Discretion

    Minneapolis-based K-V Pharmaceutical has a problem: its flagship product, Makena, isn't maturing into the cash-generating product the company hoped it would become, leaving the company to face likely financial ruin if its cash-flow situation doesn't improve dramatically within the next few months. The company's hopes for dramatic change may rest squarely on the success of a lawsuit it filed on 5 June. Reuters reports the company has filed suit against the US Food and...