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  • Regulatory NewsRegulatory News

    Facing Enterovirus Outbreak, HHS Gives FDA Power to Authorize Use of Experimental Diagnostics

    The US Department of Health and Human Services (DHHS) has declared that a strain of enterovirus now sweeping across the US has a high potential to cause a "public health emergency," thereby allowing the US Food and Drug Administration (FDA) to clear the use of drugs and diagnostic devices under special "emergency use" regulatory pathways. According to the US Centers for Disease Control and Prevention (CDC), the virus, known as enterovirus D68, is one of more than 100 n...
  • Regulatory NewsRegulatory News

    US Government Immunizes Future Manufacturers of Ebola Vaccines from Legal Liability

    The US Department of Health and Human Services (DHHS) is providing a gift to manufacturers of prospective vaccines meant to protect patients against the Ebola virus: Protection from legal liability. In an announcement in the 9 December 2014 edition of the Federal Register , DHHS said it was issuing a new declaration that would "provide liability protection for activities related to Ebola virus disease vaccines consistent with the terms of the declaration." Protection f...
  • Regulatory NewsRegulatory News

    FDA's Regulation of Generic Manufacturers, Clinical Trials Comes Under Scrutiny

    Federal oversight officials are once again poised to take a close look at actions being taken by the US Food and Drug Administration (FDA) to protect consumers. In a new Work Plan posted by the US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG)—the division in charge of auditing DHHS agencies—federal auditors say they plan to hone in on five separate areas of FDA regulation. Generic Drugs OIG says it's interested in determining "...
  • Regulatory NewsRegulatory News

    Federal Audit Finds FDA Website, Internal Network Vulnerable to Hackers

    A government audit of the US Food and Drug Administration (FDA), ordered last year after one of the agency's databases was compromised, has found the agency is vulnerable to hacking attempts which could lead to the loss of sensitive information. Background In November 2013 FDA quietly reported that several databases maintained by its Center for Biologics Evaluation and Research (CBER) had been hacked into. Information on at least 14,000 accounts had been improperly ac...
  • Regulatory NewsRegulatory News

    Hamburg, FDA Get a New Boss in New HHS Chief Sylvia Burwell

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg—and the agency she runs—will soon have a new boss. On Thursday, 5 June 2014 the full US Senate voted 78-17 to confirm Sylvia Matthews Burwell, former director of the Office of Management and Budget (OMB), to the position of secretary of the Department of Health and Human Services (DHHS). Burwell, once sworn in next week, will replace outgoing Secretary Kathleen Sebelius. While much of Burwell's fo...
  • DHHS Signs Over (a Little Bit of) Compounding Oversight Authority to FDA

    The US Food and Drug Administration (FDA) is getting some new, though not unexpected, authority this week by way of its parent organization, the US Department of Health and Human Services (DHHS). The new authority pertains to a new law passed in 2013 known as the Drug Quality and Security Act (DQSA) , which was passed in the wake of a deadly scandal involving pharmaceutical products compounded using deficient practices. Part of the law permitted FDA to more tightly r...
  • Pressure Mounts on DHHS to Overturn FDA Decision on Zohydro

    A senator has become the second legislator in two weeks to call on the secretary of the Department of Health and Human Services (DHHS) to exercise an authority-one used only once in the agency's history-to overturn a recent regulatory decision by the US Food and Drug Administration (FDA). Background: Zohydro That regulatory decision was with regard to Zohydro ER (hydrocodone bitartrate), a pure hydrocodone pill approved by FDA on 25 October 2013. The approval decision w...
  • Health Officials' Plan B Debacle Comes Back to Haunt Regulatory Process Once Again

    Under normal regulatory procedures in the US, when a new drug is approved by the US Food and Drug Administration (FDA), its approval decision is the last word. But now in the wake of the agency's approval of a painkiller that critics say is dangerous, one senator is calling for US health officials to exercise a rarely used authority to overturn the decision. Background: Plan B Until December 2011, FDA had never before seen one of its decisions overturned. But shortly af...
  • Federal Health Auditors Gear up for Investigation of FDA's Generic Drug Inspections

    The Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG) plans to investigate the US Food and Drug Administration's (FDA) track record of inspecting generic pharmaceutical manufacturers in the coming year, the group said. Background OIG is DHHS' investigative body, and serves to audit agency programs and make recommendations as to how they can improve. Often times their reports are also used by members of Congress to push for changes. O...
  • Proposed DHHS Rule on Hemapoitic Stem Cells Show Why Regulatory Definitions Matter

    As anyone working in the healthcare products sector can attest to, definitions are vitally important in the regulation of products. Definitions are the difference between a manufactured pharmaceutical product being overseen by US Food and Drug Administration (FDA) regulators and a compounded pharmaceutical product being overseen by state boards of pharmacy; the difference between an in vitro diagnostic test regulated by FDA and a lab-developed test by the Clinical Labor...
  • FDA Again Leverages Emergency Use Authority, Seeking to Stay Ahead of Deadly Mystery Virus

    For the second time in as many months, US regulators have leveraged new authority granted to them under recently-passed anti-bioterrorism legislation that allows them to approve products based on an understanding that an emerging virus could become a threat to public health. This time, however, the emerging virus is far different than the typical strains of influenza public health officials usually grapple with. Background In March 2013, the US Food and Drug Administrat...
  • Are Medical Countermeasures Meeting the Potential Needs of Children?

    Is the US government doing enough to protect children from the threat of a medical emergency caused by a chemical, biological, radiological or nuclear accident? Not as much as it could be, concludes a new report just published by the Government Accountability Office (GAO), an intra-government watchdog that regularly assesses programs for deficiencies. Background Since the events of September 2011, federal agencies, and particularly the US Food and Drug Administration (F...