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  • Regulatory NewsRegulatory News

    OIG Report on FDA’s Postmarket Surveillance of Devices Coming in 2020

    The US Department of Health and Human Services’ Office of Inspector General (OIG) will issue a report next year on the US Food and Drug Administration’s (FDA) postmarket surveillance of medical devices, which has come under fire in recent months. OIG says it will assess and describe how FDA's “established passive postmarket surveillance system” identifies and tracks safety concerns and responds to them. “We will also describe how elements of FDA's newer surveillance ...
  • Regulatory NewsRegulatory News

    HHS OIG to CMS: Avoid Paying Twice for the Same Drugs

    The US Department of Health and Human Services (HHS) Office of Inspector General (OIG) on Tuesday issued a report calling on the Centers for Medicare & Medicaid Services (CMS) to “do more to avoid paying twice for the same drugs.” The OIG found that Medicare Part D paid for drugs during 2016 that hospices should have paid for under the Medicare Part A hospice benefit. “On the basis of our sample results, we estimated that the Part D total cost was $160.8 million for dru...
  • Regulatory NewsRegulatory News

    HHS' OIG to PhRMA: Free Pharmaceuticals Needed in 2018

    With a nonprofit that paid almost $100 million in 2015 financial grants to patients now saying that it will not offer such payments in 2018, Gregory Demske, chief counsel to the Department of Health and Human Services' Office of the Inspector General (OIG), sent a letter on Thursday seeking help from the pharmaceutical industry group PhRMA in providing free drugs.  The situation arises as OIG found that the nonprofit, known as the Caring Voice Coalition (CVC), may h...
  • Regulatory NewsRegulatory News

    HHS Inspector General Finds FDA Spends User Fees Appropriately

    The US Department of Health and Human Services’ (HHS) Office of Inspector General on Thursday released a report finding that the Food and Drug Administration (FDA) generally spent prescription drug user fees appropriately. Background FDA is authorized to collect user fees from pharmaceutical and biotechnology companies seeking approval of certain human drug and biological products to expedite the review of applications. Congress reauthorizes the user fee agreem...
  • Regulatory NewsRegulatory News

    HHS Inspector General to Look Into Six FDA Programs in FY2016

    Over the next year, HHS’ Office of the Inspector General (OIG) plans to investigate the US Food and Drug Administration’s (FDA) requirements for post-marketing studies for new drugs, the exchange of information between drug supply chain partners and FDA’s oversight of networked medical devices in hospitals, as well as three other programs linked to the regulation of food and tobacco. Although the majority of OIG’s work is tied to the oversight of Medicare and Medicaid fu...
  • Feature ArticlesFeature Articles

    Correlation Between OPDP Untitled or Warning Letters and OIG Settlements or Corporate Integrity Agreements with Sponsors

    This article discusses the existence of a correlation between OPDP enforcement letters and OIG settlements or corporate integrity agreements with pharmaceutical companies. Pharmaceutical companies promote their prescription drug products for a number of reasons, including to increase consumer awareness and the number of physicians prescribing the drugs and ultimately, to drive sales. Since these prescription products may carry serious risks, their promotion is r...
  • Feature ArticlesFeature Articles

    Evolution of Board Responsibility for Compliance Program Oversight

    Will the Pfizer Class Action be the Missing Link? This article examines how OIG's expectations of the role played by a company's Board of Directors in overseeing corporate compliance programs have changed over time in a manner corresponding to Audit Committee requirements of Sarbanes-Oxley. In March 2015, a US district court tentatively approved the settlement of a class action lawsuit filed against Pfizer Inc., in connection with the off-label promotion of a number...
  • Regulatory NewsRegulatory News

    FDA Substantially Increasing its Inspections of Foreign Generic Drug Companies

    The US Food and Drug Administration (FDA) has made substantial improvements to its inspections of foreign generic pharmaceutical manufacturers, a new report by the Department of Health and Human Services' (HHS) Office of the Inspector General (OIG) claims. Background OIG's report, issued on 4 May 2015, was prompted by congressional concerns that FDA lacked sufficient resources to inspect generic pharmaceutical manufacturers, which now make up nearly 80% of the prescript...
  • 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...
  • Legislators Call for Government Investigation Into Industry Influence on FDA Approval of Painkiller

    As pressure continues to mount on the US Food and Drug Administration (FDA) over its October 2013 decision to approve a controversial pure hydrocodone painkiller known as Zohydro ER (hydrocodone bitartrate), several legislators are trying to convince the government itself to launch an investigation into the matter. Background: What is Zohydro? FDA approved Zohydro in October 2013. The approval decision was seen by many as surprising, as it followed an FDA advisory commi...
  • 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...