• 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...
  • Human Protections Oversight Body Seeks New Members

    • 06 September 2012
    Officials at the US Department of Health and Human Services (DHHS) are looking for two new members to serve on the Secretary's Advisory Committee on Human Research Protections (SACHRP), the agency announced in a Federal Register posting . SACHRP is a part of DHHS's Office of Human Research Protections, which, along with the US Food and Drug Administration (FDA), is responsible for overseeing the rights and welfare of participants enrolled in clinical trials conducte...
  • FDA Looks to Regulatory to Plan for Potential Mass Casualty Event

    Are US regulators prepared to deal with a mass casualty incident involving burns caused by a radiological, nuclear or chemical device? The question is the focus of an upcoming meeting sponsored by the US Food and Drug Administration (FDA), which said it is looking to assess how to promote burn treatment products to fill "gaps in the product landscape," and determine which regulatory pathways and testing methods best fill those gaps. The meeting is a part of a program ...
  • FDA, Data Standard Groups Promote Adoption of EHRs

    The US Food and Drug Administration (FDA), the US Department of Health and Human Services' (DHHS) Office of the National Coordinator for Health Technology (ONC) and the Clinical Data Interchange Standards Consortium (CDISC) have together issued a call for greater use of electronic health records (EHR) in clinical research. In a 6 August statement, CDISC, a nonprofit devoted to clinical regulatory standards, said the agencies' challenge involved the, "Use at least two d...
  • GSK Settles Charges, Agrees to Record-Setting Fine

    British pharmaceutical manufacturing giant GlaxoSmithKline has agreed to pay a record-setting $3 billion fine to settle criminal and civil liabilities related to marketing and general practices used to promote three of its best-selling drugs. In a statement released 2 July , US Department of Justice (DOJ) officials said GSK plead guilty to three counts of criminal conduct, including respective counts of misbranding antidepressants Paxil (paroxetine) and Wellbutrin (bupr...
  • Agency Looks to Overhaul Voluntary Fraud Reporting Program

    • 18 June 2012
    It happens to the best of us. Sometimes companies find they have managed to accidently defraud the federal government for several million dollars. For life sciences companies, this can often involve running afoul of federal regulations against the improper marketing of pharmaceutical products and medical devices, both of which have caused billions in fines to the industry in recent years. What happens next, explains the US Department of Health and Human Services' Office ...
  • Government Looks to Regulatory Science to Reduce Dependence on Animals in Preclinical Testing

    • 13 June 2012
    The US Department of Health and Human Services (DHHS) is looking ahead to assess the needs of its toxicology program, which it says is a key driver in the adoption of regulatory science-based technologies. In a report released for public comment in May 2012, DHHS, working with more than a dozen other federal agencies known as the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), said better methods are needed to assess the benefits and...
  • 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 ...
  • Federal Agencies Team Up to Issue Draft Guidance on IRB Transfers

    The US Food and Drug Administration (FDA) has released a draft guidance intending to instruct sponsors, clinical investigators (CIs) and Institutional Review Boards (IRBs) on best practices for transferring clinical trial oversight to a new IRB. The proposed guidance harmonizes regulatory interpretations between FDA and the US Department of Health and Human Services' Office for Human Research Protections (OHRP). The agencies said in a Federal Register statement they pl...
  • DHHS Looks to Social Media for Warning Signals

    • 22 March 2012
    A new US Department of Health and Human Services (DHHS) initiative is looking to use social media tools-specifically the micro-blogging website Twitter-to provide the agency with advanced signals to help identify public health emergencies. In a 20 March press release, DHHS said it is looking for developers to create tools that look at real-time data on public health issues, with a particular focus on illnesses. The agency hopes to develop a tool that will be "useful as ...
  • 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...
  • FDA Gets High Marks for FOIA Request Transparency

    A report by the House Oversight Committee has found many federal agencies to be deficient when it comes to tracking basic information regarding Freedom of Information Act (FOIA) requests, including the US Department of Health and Human Services (DHHS). The report "found that many federal agencies failed or struggled to transparently demonstrate an ability to track basic information about the processing" of FOIA requests. While DHHS-the parent organization of the ...