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  • Regulatory NewsRegulatory News

    Hiring Freeze at FDA: Upton and DeGette Say it Puts Priorities at Risk

    Hampering the US Food and Drug Administration’s (FDA) ability to hire puts bipartisan priorities at risk, Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) wrote in a letter sent Tuesday to the acting director of the Office of Management and Budget (OMB). The letter comes as President Donald Trump in late January ordered a freeze on all government hiring, which has some exemptions for public health, though it’s unknown how the freeze impacts FDA or user fee funding to h...
  • Regulatory NewsRegulatory News

    House Committee Raises 'Grave Concerns' Over Patient Impact of NIH Closure of Drug Production Unit

    The House Energy and Commerce Committee is asking the National Institutes of Health (NIH) for more information on how the temporary closure of its drug manufacturing facility has impacted patients in NIH clinical trials. Background The US Food and Drug Administration (FDA) earlier this summer uncovered a series of deficiencies at NIH's Pharmaceutical Development Section (PDS), which acts as a specialty compounding pharmacy managing investigational drugs for clinical tri...
  • House Committee Unveils Intent to Overhaul FDA Regulatory Framework

    A bipartisan group of legislators on the House Energy and Commerce Committee has launched a new initiative its members are calling the "21 st Century Cures Initiative," aimed at accelerating "the pace of cures and medical breakthroughs in the US." In a statement released on 30 April 2014, E&C committee members Fred Upton (R-MI) and Diana DeGette (D-CO) said they're looking to "broadly collaborate" with federal agencies, patients, scientists, academics and members of...
  • Congressional Investigators Ramp up Pressure on FDA over Meningitis Outbreak

    What did the US Food and Drug Administration (FDA) know, and when did it know it? That's the question being asked of agency officials this week as legislators with the House Energy and Commerce (E&C) Committee sent FDA a letter asking for all details regarding its oversight of a compounding pharmacy. The E&C Committee is in the midst of investigating the New England Compounding Center, which has been linked to a massive outbreak of meningitis that has thus fa...
  • Legislators Slam DHHS, FDA for Special Hiring Practices

    The US Food and Drug Administration (FDA) has increased its use of special hiring authorities more than 50% in recent years to bring on staff members who can be paid more than the normal limit for federal employees, and some legislators are none too pleased at the trend. In a 14 September 2012 hearing, the Government Accountability Office (GAO), which earlier released a report on the topic , testified that the Department of Health and Human Services' (DHHS) use of speci...
  • House Committee to Vote on User Fee Bill, Aiming for Passage in July

    The US House of Representatives' Energy and Commerce Committee is set to hold a vote on Thursday, 10 May on a collection of user fee legislation being dubbed the Food and Drug Administration (FDA) Reform Act of 2012 . The bill would reauthorize the Prescription Drug User Fee Act and the Medical Device User Fee Act , authorize the Generic Drug User Fee Act and the Biosimilars and Interchangeable Products User Fee Act , and make a number of reforms to FDA's review...