• 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...
  • Republicans, CEOs Blast FDA's Medical Device Review Process

    Republican members of the House Energy and Commerce Committee (E&C) recently took aim at the US Food and Drug Administration's (FDA) medical device approval policies, calling for the agency to get products to market more quickly after hearing concerns raised by a number of executives. At a meeting with a handful of medical device CEOs entitled, " Jobs and Innovation Forum on Medical Devices ," the congressmen took aim at FDA, and in particular its medical device regu...
  • House Meets to Discuss PDUFA, MDUFA User Fees

    • 18 April 2012
    The House Energy and Commerce Committee is meeting 18 April starting at 10:15 AM to discuss various proposed user fee agreements, including the Prescription Drug User Fee Act (PDUFA)  and the  Medical Device User Fee Act (MDUFA)  reauthorization bills on 18 April. The hearing, entitled "US Food and Drug Administration User Fees 2012: How Innovation Helps Patients and Jobs," will be taking place at room 2123 of the Rayburn House Office Building. A webcast...
  • What You Need To Know About The Supreme Court Hearing on the Affordable Care Act: Day Three

    • 28 March 2012
    The Supreme Court of the United States (SCOTUS) is scheduled to hear arguments today on the Patient Protection and Affordable Care Act's (PPACA) Medicaid expansion provisions and whether the 'individual mandate' is severable from the PPACA . In preparation for those arguments-and the rest of the case- Regulatory Focus has assembled a list of what you need to know about the case, the court, the hearings, the arguments and more. Medicaid: NPR - Supreme Court's Med...
  • What You Need To Know About The Supreme Court Hearing on the Affordable Care Act

    • 27 March 2012
    The Supreme Court of the United States (SCOTUS) is scheduled to hear arguments today on the Patient Protection and Affordable Care Act's (PPACA) 'individual mandate' provisions. In preparation for those arguments-and the rest of the case- Regulatory Focus has assembled a list of the essentials of what you need to know about the case, the court, the hearings and more. The Individual Mandate: Reuters - Supreme Court moves to heart of healthcare case The New York...
  • Cosmetic Regulation Under Review in Congress

    The House Energy and Commerce Committee is slated to review the safety and regulation of cosmetics in a hearing scheduled for 27 March. The hearing intends to explore the possibility of establishing national standards for cosmetic ingredients, which the Committee writes "would serve to further public health by ensuring these decisions are made using sound science and ensure that the interstate flow of cosmetic products is not disrupted by differing State standards." "U...
  • What You Need To Know About Today's Supreme Court Hearing on the Affordable Care Act

    • 26 March 2012
    The Supreme Court of the United States (SCOTUS) is scheduled to hear three days of arguments on the Patient Protection and Affordable Care Act (PPACA) starting Monday, 26 March. In preparation for those arguments, Regulatory Focus has assembled a list of everything you need to know about the case, the court, the hearings and more. Case Summary: Washington Post Wonkblog - SCOTUS 101: A Wonkblog guide to health care oral arguments Kaiser Health News - The Health...
  • Senate Schedules PDUFA Hearing

    The first hearing in the US Senate for the Prescription Drug User Fee Act ( PDUFA ) reauthorization has been scheduled for next week. The Senate Committee on Health, Education, Labor and Pensions' (HELP Committee) will meet on 29 March 2012 at 10:00 AM EST to discuss the act, which is requires renewal by the end of the year. Witnesses for the hearing have not yet been announced. The user fee legislation is on a fairly tight deadline, as Regulatory Focus reported...
  • Hearings to Explore Budget, Prescription Drug Issues

    A trio of Congressional hearings the week of 27 February will explore the proposed budget of the US Food and Drug Administration (FDA), the proposed budget of the US Department of Health and Human Services (DHHS) and prescription drug diversion. On 29 February 2012, FDA Commissioner Margaret Hamburg will appear before the US House Committee on Appropriations . Hamburg will be joined by FDA Assistant Commissioner for Budget Patrick McGarey and Deputy Assistant Secretary ...
  • MDUFA Hearing Tomorrow, FDA's Shuren to Testify

    The House Energy and Commerce Committee is scheduled to hold a hearing on 15 February on the Medical Device User Fee Act (MDUFA) reauthorization. Testimony will be heard from Jeffery Shuren , the director of the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), and several other prominent industry and patient representatives. FDA and industry representatives came to a deal "in principle" on the MDUFA legislation on 1 February ...
  • PDUFA Hearings Highlight Support and Concerns About Legislation

    The US House Committee on Energy and Commerce (E&C) held a hearing on 1 February 2012 on the Prescription Drug User Fee Act (PDUFA) , the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research and Equity Act (PREA) . The hearing highlighted the broad support that all three pieces of legislation have in Congress. The hearings also hinted at certain issues that may come to dominate the debate over the coming months, including conflict of interest ...
  • PDUFA Witness List Revealed, Hearing Set for Wednesday

    The US House Energy and Commerce Committee's Subcommittee on Health is set to hold a hearing on Wednesday, 1 February on the reauthorization of the Prescription Drug User Fee Act IV (PDUFA) , which is set to expire later this year. The hearing, entitled " Reauthorization of PDUFA : What It Means for Jobs, Innovation, and Patients ", will feature: Commissioner of the US Food and Drug Administration (FDA) Margaret A. Hamburg, MD President of Pfizer's Specialty Care a...