• Pressure Mounts on DHHS to Overturn FDA Decision on Zohydro

    A senator has become the second legislator in two weeks to call on the secretary of the Department of Health and Human Services (DHHS) to exercise an authority-one used only once in the agency's history-to overturn a recent regulatory decision by the US Food and Drug Administration (FDA). Background: Zohydro That regulatory decision was with regard to Zohydro ER (hydrocodone bitartrate), a pure hydrocodone pill approved by FDA on 25 October 2013. The approval decision w...
  • Health Officials' Plan B Debacle Comes Back to Haunt Regulatory Process Once Again

    Under normal regulatory procedures in the US, when a new drug is approved by the US Food and Drug Administration (FDA), its approval decision is the last word. But now in the wake of the agency's approval of a painkiller that critics say is dangerous, one senator is calling for US health officials to exercise a rarely used authority to overturn the decision. Background: Plan B Until December 2011, FDA had never before seen one of its decisions overturned. But shortly af...
  • BREAKING: Federal Judge Orders FDA to Make 'Plan B' Available Over the Counter to All Ages

    In a stunning reversal of a 2011 order by US Department of Health and Human Services Secretary Kathleen Sebelius, a federal judge has ordered the US Food and Drug Administration (FDA) approve an application by Teva Pharmaceuticals that would permit their Plan B (levonorgestrel) morning after pill to be made available as an over-the-counter product instead of by prescription, saying Sebelius likely lacked the authority to make such a decision, and that regardless of her au...
  • Sebelius Writes to Congress, Reminding Them of Sequester's Impact on User Fees

    US Department of Health and Human Services (DHHS) Secretary Kathleen Sebelius has quietly confirmed what many in the industry have long known: User fees paid to the US Food and Drug Administration (FDA) under various legislative vehicles and agency programs are at risk under the sequester. Background On 1 March 2013, without intervention from Congress, all federal agencies (with the exception of the Department of Defense) will be subjected to an annualized 8% reduction ...
  • FDA Declines to Take Action Against Unusual 'Plan B' Distribution Scheme

    • 30 January 2013
    In the waning days of 2011, US Department of Health and Human Services (DHHS) Secretary Kathleen Sebelius conducted an unprecedented action when she ordered the US Food and Drug Administration (FDA) to overturn its finding that Plan B (levonorgestrel) would be safe and effective for over-the-counter use for those under the age of 17. But now FDA has signed off on an agreement that could soon see the pill being dispensed at an unusual location: vending machines. That d...
  • US Health Secretary to Remain in Second Obama Term

    • 10 January 2013
    In a widely expected move, US Department of Health and Human Services Secretary (DHHS) Kathleen Sebelius, an Obama Administration official who was appointed to the position in early 2009, will stay on in her position into at least the early parts of President Barack Obama's second term, The Hill reports . Sebelius would be among just a small handful of Cabinet officials who would be staying on through the second term. Both she and her department are in the midst of ...
  • FDA Given New Authority to Oversee Clinical Trials Data Reporting

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg is receiving some new authority by way of the Department of Health and Human Services (DHHS), both agencies said in a Federal Register statement . Under section 801 of the Public Health Service Act (PHSA) , as amended by the FDA Amendments Act of 2007, DHHS is directed to establish a clinical trial registry data bank, which now exists as www.ClinicalTrials.gov run by the National Institut...
  • Lawmakers: Reform 'Indefensible' Blood Donation Policy

    A group of 62 US lawmakers sent US Department of Health and Human Services (DHHS) Secretary Kathleen Sebelius a letter on 11 June expressing their collective support for a draft policy announced in March 2012 that would examine the feasibility of relaxing rules currently prohibiting gay men from donating blood or plasma. In DHHS's Request for Information on Design of a Pilot Operational Study to Assess Alternative Blood Donor Deferral Criteria for Men Who have Had Sex ...
  • US, Mexico Announce Plan to Strengthen Regulatory Cooperation

    US Health and Human Services Secretary Kathleen Sebelius and Mexico's Secretary of Health Salomón Chertorivski jointly announced the launch of a new program aimed at increasing regulatory cooperation at a meeting in Geneva, Switzerland on 22 May. Sebelius and Chertorivski were at the 65 th World Health Assembly, where both acknowledged their mutual goals in promoting public health. "It is important to strengthen the programs of regulation and surveillance of med...
  • Report: Clashes Between White House, FDA Frequent

    A report in The New York Times indicates the US Food and Drug Administration (FDA) and the Obama Administration are frequently at odds-partially the result of poor communication and partially the result of poor political optics-which has caused significant amounts of tension between the two government bodies. The report notes numerous instances where the Administration and FDA have clashed, including the banning of Primatene asthma inhalers, Health and Human Services S...
  • Union of Concerned Scientists Decries Corporate Interference in FDA Decision Making

    Scientific agencies like the US Food and Drug Administration (FDA) are under increasing pressure from "corporate abuse" of the political and legal processes, claims a new report from the Union of Concerned Scientists (UCS). The report, Heads They Win, Tails We Lose , illustrates a number of case studies in which companies sought to influence-often successfully-FDA decision making by exerting pressure through political and legal channels. Of note: "New Jersey company...
  • Sebelius: Manufacturers, Market To Blame For Drug Shortages

    US Department of Health and Human Services (DHHS) Secretary Kathleen Sebelius told a public health meeting that manufacturers and market pressures are primarily to blame for drug shortages, reports the Philadelphia Inquirer . Sebelius spoke on 16 February to a health coverage forum in Philadelphia, which covered a wide range of topics including the issue of drug shortages. Sebelius said that "there is a gap between demand and manufacturing capacity" that DHHS is una...