• 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...
  • US Government Looks to Re-Evaluate Incentives for States to go after Regulatory Fraud

    • 15 March 2013
    The US Department of Health and Human Services (DHHS) plans to review state laws regarding regulatory fraud against Medicaid programs, including off-label promotion of pharmaceutical products and medical devices, to determine if the programs remain eligible for enhanced incentives meant to ratchet up pressure against bad regulatory practices. Background When companies are found-or simply alleged-to have participated in off-label marketing of their products, kickbacks to...
  • Government Report Shows Endemic Deficiencies in REMS Assessments

    A new report just published by the Department of Health and Human Services (DHHS) claims that the US Food and Drug Administration (FDA) lacks sufficient data to determine whether one of its flagship postmarketing safety methods, Risk Evaluation and Mitigation Strategies (REMS), is actually effective at ensuring product safety. Background REMS plans were instituted in 2007 under the FDA Amendments Act , and were seen as a response to a number of product safety scandal...
  • 'Record-Breaking Year' for Fraud Recovery Has Roots in Regulatory Missteps

    2012 was a record year for regulatory-related pain and government gain, claims a new report out from the US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG), the office responsible for overseeing fraud prevention and recovery efforts. The report , jointly authored by OIG and the US Department of Justice (DOJ), explained that 2012 saw the highest-ever amount of fines recovered from those who had defrauded or attempted to defraud the g...
  • Senator Calls--Again--for White House to Release Sunshine Act Rules

    A prominent senator is once again calling upon federal officials to pass a long-delayed rule regarding the transparency of payments made by companies to healthcare providers, saying the delays are "unacceptable." Sen. Charles Grassley (R-IA), is the ranking Republican member of the Senate Committee on the Judiciary, and along with former Sen. Herb Kohl (D-WI) sponsored and wrote the Physician Payments Sunshine Act (Sunshine Act), which eventually became part of the 201...
  • Government Report Details FDA's Progress, Failures in Implementing Improvements

    The Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG)is many things: an investigator of programs, a finder of fraud and a recommender of program improvements. A new OIG report makes the case that another superlative might belong on that list: ignored. The agency puts out dozens of reports each year documenting what it sees as program inefficiencies, problems and weaknesses. In 2012, for instance, the agency has issued reports on the ...
  • OIG Report Details Scope of Fines Levied on Pharmaceutical Manufacturers in 2012

    • 29 November 2012
    The US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG), the office charged with investigating potential legal violations and recovering funds for taxpayers, has had a busy year. In a report submitted to Congress this week detailing the agency's actions for the second half of the fiscal year (April through September), Inspector General Daniel Levinson said his agency had recovered just shy of $7 billion for taxpayers-nearly three ti...
  • FDA Draft Guidance Seeks Clarity on IRBs' Clinical Research Oversight Responsibilities

    A new draft guidance published by the US Food and Drug Administration (FDA) aims to clarify the responsibilities of institutional review boards (IRBs) in the oversight of investigators, research sites and investigational authority of sponsors. The draft guidance, IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites and the Determination of Whether an IND/IDE is Needed , aims to clarify the roles of IRBs, which are charged ...
  • Separate OIG Reports Uncover Systemic Problems With Regulation of Supplement Industry

    Two new reports released by the US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG) call for additional oversight over the dietary supplement industry, with government investigators chiding the industry for routinely flouting federal requirements and being difficult to track . That supplement companies routinely run afoul of US Food and Drug Administration (FDA) regulation should be of no surprise to its regulators. Its officials, ...
  • Several FDA Programs to be Investigated in 2013 Under Proposed OIG Work Plan

    The US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG), an investigative body charged with overseeing program performance and integrity, plans to devote part of its time and resources to investigating several programs run by the US Food and Drug Administration (FDA) during 2013. OIG's plans were revealed on 2 October in the release of its Fiscal Year 2013 Work Plan , a 123-page document detailing the basic outline of its investigati...
  • 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...
  • DHHS Plans to Assess Need for Revisions to Human Research Protections at Upcoming Meeting

    • 21 September 2012
    The US Department of Health and Human Services (DHHS) is planning to meet in October to discuss whether current protections afforded to human research subjects are adequate, or whether new regulations and guidelines are needed. The meeting, announced in the Federal Register on 20 September , will involve DHHS' Secretary's Advisory Committee on Human Research Protections ( SACHRP ). The group, which acts as an advisory committee, is charged with providing recommendatio...