• 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...
  • Hamburg: User Fees Might be Solution for Funding Increasing Regulation of Compounding Industry

    Since the 1990s, the US Food and Drug Administration (FDA) has leveraged industry-paid user fees for an increasing number of product areas, starting with prescription drugs and branching off into medical devices, veterinary drugs, biological products and generic pharmaceuticals. Now, a fourth type of user fee may be on the horizon; one for compounded pharmaceutical products. Call for New Authority The call for the authority to levy user fees on compounded pharmaceutical...
  • Hamburg: Compounding, Global Regulatory Issues Top Two Upcoming Areas of Regulatory Focus

    Pharmaceutical compounding and global supply chain issues are the two largest regulatory areas of upcoming focus for the US Food and Drug Administration (FDA), Commissioner Margaret Hamburg said in a 2 March 2013 interview with Yale University's The Politic . Compounding Issues Remain In the wide-ranging interview, Hamburg talked about the issues associated with pharmaceutical compounding and a recent outbreak of meningitis several times. In response to a question re...
  • Hamburg: Quality one of FDA's 'Highest Priorities' in 2013, Agency Creating New Quality Office

    In a wide-ranging speech before the Generic Pharmaceutical Association's annual meeting in Florida, US Food and Drug Administration (FDA) Commissioner Margaret Hamburg said her regulatory agency will be placing an increased focus on quality issues in 2013, noting its integral role in recurring drug shortages and other problems. The generics industry, Hamburg said, is "playing an increasingly central and transformative role in our nation's health care system," adding that...
  • Politico: FDA, Other Domestic Agencies Unable to Freely Talk about Sequestration

    If federal agencies, including the US Food and Drug Administration (FDA), seem to be approaching the looming threat of fiscal devastation rather quietly, it's not by accident, reports Politico . That's because Cabinet-level officials, including Kathleen Sebelius, secretary of the Department of Health and Human Services and FDA Commissioner Margaret Hamburg's boss, have been under a virtual gag order from executive branch officials, said Politico . Any remarks they...
  • Legislators Threaten to Subpoena FDA over Requested Documents

    US regulators are coming under renewed scrutiny regarding their oversight of pharmaceutical compounders, with House legislators threatening to subpoena the US Food and Drug Administration for what they allege is a failure to provide relevant documents to the Energy and Commerce Committee despite repeated requests. Background In 2012, a rash of drug shortages caused an increase in the number of entities looking to utilize the services of pharmaceutical compounders, which...
  • Legislators Press FDA to Release Agency Materials Related to Meningitis Outbreak

    Republican legislators with the House's Energy and Commerce Committee, the committee charged with overseeing the US Food and Drug Administration (FDA), now say the agency has until 30 November to acquiesce to their demands for access to internal documents related to a recent outbreak of fungal meningitis. The Energy and Commerce Committee's subcommittee on health has been investigating an outbreak of fungal meningitis, now understood to have been caused by contaminated...
  • Legislators Slam Hamburg for Failing to Halt Meningitis Outbreak

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg was faced with skeptical and at times angry questioning by legislators at a hearing regarding a recent outbreak of fungal meningitis that has killed dozens and made hundreds ill. In her prepared testimony, Hamburg said the crisis had been caused by a confusing patchwork of regulation in which FDA theoretically had authority over some, but not all, compounding operations, but was consistently operating in...
  • Hamburg Calls for New Regulatory Authority in Wake of Compounding Scandal

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg has called upon Congress to grant the agency new authorities to regulate and oversee pharmaceutical compounders with the help of a new regulatory paradigm, according to testimony scheduled to be delivered before a House subcommittee. Hamburg is scheduled to appear at a 10 a.m. hearing before the House Energy and Commerce committee to discuss FDA's response to the meningitis outbreak which has resulted ...
  • Congress Calls on Hamburg, Compounding Pharmacist to Testify at Hearing

    Some people get invitations to appear before Congress; others, subpoenas. Barry Cadden, co-owner of the New England Compounding Center (NECC), is of the latter category. The House Energy and Commerce (E&C) Committee announced on 6 November that it had sent a subpoena to Cadden, whose company has been linked to an outbreak of fungal meningitis that has claimed the lives of dozens of patients and made hundreds more ill. The E&C Committee has scheduled a high-pr...
  • Ireland, FDA's Legislative Director, Transitions to new Advisory Role Within Agency

    The US Food and Drug Administration's (FDA) top legislative official, Jeanne Ireland , will leave her current post and assume a new role as senior advisor to Commissioner Margaret Hamburg, the commissioner wrote in an email to FDA staff on 1 November. Ireland served since 2009 as the head of the Office of Legislation (OL), an office charged with coordinating legislation and working with legislators to defend the agency, advocate on its behalf and advise members of Congr...
  • World's Top Regulators Tackle Ethics of Pharmaceutical Innovation

    The heads of the world's two leading drug regulatory agencies, US Food and Drug Administration (FDA) Commissioner Margaret Hamburg and European Medicines Agency (EMA) Executive Director Guido Rasi, tackled the issue of regulatory ethics on a panel they shared with Nobel Laureate Professor Elie Wiesel at the 3rd annual Galien Foundation Forum in New York on 17 October. Both Hamburg and Rasi agreed that ethics is a matter of trust. In the regulatory environment, this ...