• 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...
  • Revised FDA Enforcement Report Stresses Clarity, Data Accessibility

    Regular readers of the US Food and Drug Administration's (FDA) weekly enforcement reports-the vehicle through which the agency publishes recalls initiated by or reported to FDA-will see a big change to the reports starting today. On 21 June, FDA announced it has completed a planned revision of the reports to make information easier to understand, quicker to read and more accessible to technology. In an announcement in early June 2012 , FDA said it planned to roll out a ...
  • FDA Maintains Compounding Exemption for KV Pharmaceuticals' Makena

    The US Food and Drug Administration (FDA) has announced the results of an investigation into compounded versions of KV Pharmaceutical's Makena (hydroxyprogesterone caproate), used to prevent pre-term births, which the company alleged were compounded to a lesser standard than allowed under the company's approved New Drug Application (NDA). The agency said in a statement it would continue to allow compounding of the drug after its investigation yielded no significant concer...
  • FDA Plans Major Overhaul of Recall Reporting

    The US Food and Drug Administration's (FDA) weekly enforcement reports, which detail product recalls and corrections taken during the week, are about to get a major overhaul according to an agency announcement. The agency last week reported in a little-noticed item within its enforcement report that it would be making changes to the way it updates its enforcement reports for pharmaceutical product recalls. The agency wrote at the time it intends to "modify the drug pro...
  • FDA Looking to Speed up Public Notification of Recalls

    An item tucked within the US Food and Drug Administration's (FDA) weekly enforcement report indicates the agency is looking to speed up the way it notifies the general public regarding pharmaceutical recalls. FDA current publishes its recalls of all products in an extensive and sprawling document known as its Enforcement Report, which it publishes every Wednesday. The Enforcement Report is organized by product type and by the severity of the recall, but it is difficult t...
  • Judge's Order Banning Enforcement Discretion Appealed by FDA

    The US Food and Drug Administration (FDA) said it has appealed a decision issued in March 2012 by US District Court Judge Richard Leon, who said the agency erred in allowing a drug commonly used in executions into the country without first testing its effectiveness, reports Bloomberg . The drug, sodium thiopental, has been at the center of numerous courtroom skirmishes between proponents and opponents of the death penalty. Opponents hope that by restricting access to th...
  • Agency Increasing Number of Supplement Inspections, Says Fabricant

    The number of inspections conducted by the US Food and Drug Administration (FDA) is increasingly rapidly as the agency moves to crack down on violators of quality regulations, the Director of FDA's supplement program said, reports Natural Products Insider . Daniel Fabricant, director of FDA's Division of Dietary Supplement Programs, said the agency is starting to use its authorities more aggressively-something Regulatory Focus took note of in April 2012 and May 2...
  • Hamburg Touts Agency's Efforts to Curb Drug Shortages

    • 04 May 2012
    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg said her agency has been remarkably successful in curbing drug shortages and working with industry to provide advanced warning when the agency is unable to prevent a shortage. In a posting on the agency's FDA Voice blog, Hamburg said she is "both amazed and delighted to see the progress that's been made." Hamburg noted advanced warning of shortages-thanks in part to an FDA rule asking manufacturers to...