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  • Regulatory NewsRegulatory News

    GAO details ongoing problems with FDA's lab safety oversight

    The US Government Accounting Office (GAO) found that many elements of an effort to improve laboratory safety at the Food and Drug Administration (FDA) have not been met, over three years after establishing an Office of Laboratory Safety. For example, the safety oversight office still cannot perform unannounced laboratory inspections, according to the report .   Prompted by the 2014 discovery of boxes of smallpox virus that were improperly stored in a laboratory cold r...
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    GAO highlights continued PPE shortages in COVID-19 report

    The United States continues to struggle with shortages of personal protective equipment (PPE) and testing supplies due to high global demand and the fact that most supplies are made outside of the US, according to new findings from the US Government Accountability Office (GAO).   In a wide-ranging report on the US federal response to COVID-19, the GAO issued 16 new recommendations for federal agencies spanning the medical supply chain, vaccines and therapeutics, COVI...
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    GAO Raises Questions on FDA’s Orphan Drug Designation Process

    The Government Accountability Office (GAO) announced Friday that it has found that the US Food and Drug Administration (FDA) does not always ensure that all information is consistently recorded and evaluated when making orphan drug designation determinations. The missing of these critical steps by the agency in some cases means that FDA reviewers do not fully understand the context of a drug’s intended use for the rare disease, GAO said. “The Commissioner of FDA shou...
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    GAO Calls on FDA to Evaluate its Efforts on Least Burdensome Approach for Devices

    The Government Accountability Office (GAO) has told the US Food and Drug Administration (FDA) to develop metrics to evaluate its performance in implementing its least burdensome approach to regulating medical devices, according to a report released on Tuesday. Congress first required FDA to implement a least burdensome approach for reviewing 510(k) and premarket application (PMA) submissions in the 1997 Food and Drug Administration Modernization Act (FDAMA) . Since then...
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    GAO to FDA: Publish Plans to Issue or Revise Guidance on Complex Generic Drugs

    The US Government Accountability Office (GAO) on Tuesday called on the US Food and Drug Administration (FDA) to announce plans to issue or revise guidance for complex generic drugs and FDA said it agrees with the recommendation and is working to do just that. The 50-page GAO report comes as FDA has sought to improve the way it reviews and approves these complex generic drugs, which can have a complex formulation, active ingredient, route of delivery, dosage form or ...
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    GAO: Retail Drug Price Expenditures Have Nearly Doubled Since 1990s

    The US Government Accountability Office (GAO) on Tuesday released a new report on the pharmaceutical industry's sales and expenses related to research and development (R&D), noting that the amount of money people spend on prescription drugs has nearly doubled since the 1990s, mostly because of brand-name drugs. Retail prescription drug expenditures were estimated to account for about 12% of total personal health care service spending in the US in 2015, up from abou...
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    FDA Seeks Tweaks to Right-to-Try Bill in House E&C Hearing

    The House Energy & Commerce Committee on Tuesday held a hearing to discuss a "Right-to-Try" bill passed in the Senate that the US Food and Drug Administration (FDA) is seeking to change. The hearing discussed a bill that would seek to undercut FDA’s oversight of a program, known as expanded access, whereby terminally ill patients and their doctors can request access to an investigational drug outside of a clinical trial. Right-to-Try laws have now passed in 37 states...
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    GAO: FDA Improved Expanded Access but More Clarity Necessary

    With the rise of Right-to-Try legislation across states in the US, it might seem like patients with serious or life-threatening ailments and no other comparable medical options might have difficulties in obtaining access to investigational drugs outside of a clinical trial because of the US Food and Drug Administration (FDA). But a new Government Accountability Office report released Tuesday lends credence to many who have voiced concerns with the Right-to-Try laws,...
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    GAO: FDA Needs a Plan for GDUFA Carryover Fees

    As Congress looks to reauthorize the US Food and Drug Administration's (FDA) user fee programs, the Government Accountability Office (GAO) on Monday released a report saying that FDA should develop a plan for managing unspent fees collected from generic drugmakers. "Such a documented plan could aid Congress in determining the appropriate amount of user fees to be collected by the agency during the annual appropriations process and when considering a reauthorization of th...
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    GAO Survey of State Regulation of Drug Compounding Offers Mixed Results

    Among the local drug compounding regulators for 50 states, Washington, DC, Guam, Puerto and the US Virgin Islands, many say they are working with and appreciate the help of the US Food and Drug Administration (FDA), but only seven out of 50 respondents could differentiate all data on drug compounding for human use versus animal use. Building on a 2016 report , the new survey  results released by the US Government Accountability Office on Friday on the state regulatio...
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    GAO: Drugmakers Want More Clarity on Antibiotic Incentives

    Despite some improvements, drugmakers say the US Food and Drug Administration (FDA) has not fully clarified its expectations for developing new antibiotic drugs or detailed how to access new incentives, according to a new report by the Government Accountability Office (GAO). Specifically, GAO says that FDA has issued 14 updated or new guidances focused on antibiotics since the Generating Antibiotic Incentives Now (GAIN) Act was passed as part of the Food and Drug Admi...
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    GAO: FDA's Ability to Monitor Drug Shortages Remains a Concern

    The US Food and Drug Administration's (FDA) oversight of medical products remains a high-risk area for the federal government, particularly with regard to the agency's oversight of drug shortages, according to a report from the Government Accountability Office (GAO) released Wednesday. Despite commitment from FDA leadership to improve drug availability, GAO says it no longer considers FDA's action plan to be effective. As a result, GAO has downgraded its assessment of F...