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  (3)GAO’s reports and testimonies give Congress, federal agencies, and the public timely, fact-based, non-partisan information that can improve government operations and save taxpayers billions of dollars.Jump To:
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                    Most Recent Reports**1 - 20 of 580 Reports**
	
	

	
	  **Released on   Mar 25, 2024**
          Clinical Research: FDA Should Evaluate Its Efforts to Recruit and Retain Its Inspection Workforce
    GAO-24-106383
      Published:   Feb 22, 2024
. 
        Publicly Released:   Mar 25, 2024
.
    The FDA oversees clinical trials and other research involving human subjects, mostly for drugs trying to get FDA approval. This includes conducting inspections in hospitals and other healthcare settings in the U.S. and abroad. Recruiting and retaining investigators for these inspections has been a challenge—partly due to low compensation and heavy travel. This has resulted in fewer inspections and a less experienced workforce. FDA has...
          Science & Tech Spotlight: At-Home Tools to Diagnose Alzheimer's, Parkinson's, and Related Diseases
    GAO-24-107306
      Published:   Mar 25, 2024
. 
        Publicly Released:   Mar 25, 2024
.
    Neurodegenerative diseases affect about 7 million people in the U.S., with cases expected to increase. This Spotlight covers cognitive assessment apps and wearable sensors designed for home use. They can collect data on patients' cognitive and motor abilities and help detect symptoms of Alzheimer's and other neurodegenerative diseases. Doctors can use data from these tools to diagnose diseases earlier and more accurately, and these tools...
      **Released on   Feb 29, 2024**
          Biomedical Research: Actions Needed to Adopt Collaboration Practices to Address Research Duplication
    GAO-24-106757
      Published:   Feb 29, 2024
. 
        Publicly Released:   Feb 29, 2024
.
    The federal government has long invested in biomedical research through different Department of Health and Human Services agencies. This report, the first in a series, looks at potential duplication of research efforts across four such agencies. The agencies have practices in place to avoid unnecessary research duplication. For example, agency staff regularly meet to share priorities and identify duplicative work. In addition, the newest health...
      **Released on   Feb 5, 2024**
          Drug Safety: FDA Has Faced Persistent Challenges Overseeing Foreign Drug Manufacturing
    GAO-24-107359
      Published:   Feb 6, 2024
. 
        Publicly Released:   Feb 5, 2024
.
    This testimony discusses our long-standing concerns about the Food and Drug Administration's oversight of the global pharmaceutical supply chain—an issue on our High Risk List since 2009. More than 50% of drug manufacturers supplying the U.S. market are overseas. FDA inspections of manufacturers are critical for drug safety and effectiveness. But pandemic disruptions and staff shortages led to a backlog of foreign manufacturers needing inspection...
      **Released on   Jan 25, 2024**
          Federal Regulation: Selected Emerging Technologies Highlight the Need for Legislative Analysis and Enhanced Coordination
    GAO-24-106122
      Published:   Jan 25, 2024
. 
        Publicly Released:   Jan 25, 2024
.
    Agencies face challenges regulating drones, medical devices with artificial intelligence, and other emerging technologies in a timely manner. We asked agencies that regulate some of these complex, rapidly evolving technologies about their strategies. They told us that they: Use varied approaches—including strategic foresight tools like "scenario planning"—to anticipate regulatory issues Coordinate with other federal agencies and foreign governments to share information and achieve shared goals...
      **Released on   Jan 18, 2024**
          Food Safety: FDA Should Finalize Plans to Implement Its Rule to Help Trace Source of Outbreaks
    GAO-24-106563
      Published:   Jan 18, 2024
. 
        Publicly Released:   Jan 18, 2024
.
    Although the U.S. food supply is generally considered safe, foodborne illness is a common public health problem. Certain foods—like fresh produce and seafood—have often been linked to foodborne illness outbreaks. The Food and Drug Administration has a new rule requiring detailed records on certain foods as they move through the supply chain, which can help trace the sources of outbreaks. FDA has taken some steps—such...
      **Released on   Jan 11, 2024**
          Prenatal Supplements: Amounts of Some Key Nutrients Differed from Product Labels
    GAO-24-106689
      Published:   Dec 12, 2023
. 
        Publicly Released:   Jan 11, 2024
.
    Unlike medications, dietary supplements—including those for prenatal care—don't have to be evaluated for safety or effectiveness by the Food and Drug Administration before reaching stores. This Q&A report assesses whether labels for over-the-counter prenatal supplements reflect actual amounts of vitamins and minerals in them. Our testing showed that 11 of 12 prenatal supplements had at least one nutrient above or below the levels noted on...
      **Released on   Dec 6, 2023**
          Cosmetic Safety: Better Planning Would Enhance FDA Efforts to Implement New Law
    GAO-24-105542
      Published:   Dec 6, 2023
. 
        Publicly Released:   Dec 6, 2023
.
    Cosmetics include makeup, shampoo, toothpaste, and more—and many people use multiple cosmetics in their daily or weekly routines. Research has shown that cosmetics may contain harmful substances that can be present intentionally, e.g., as preservatives, or unintentionally, e.g., as natural impurities in ingredients. In late 2022, a law expanded the Food and Drug Administration's authority to oversee cosmetic safety. While FDA has taken steps to...
      **Released on   Sep 8, 2023**
          Medical Advertising: Federal Oversight of Devices
    GAO-23-106197
      Published:   Sep 8, 2023
. 
        Publicly Released:   Sep 8, 2023
.
    There are many TV, print, and online ads for medical devices, such as blood pressure monitors or contact lenses. Direct-to-consumer ads can educate people about devices that may help them. But some of the ads can raise concerns for consumers, doctors, and patients, such as: False advertising Ads that create high demand for a product, which can lead to higher costs Ads that target vulnerable...
      **Released on   Sep 5, 2023**
          Medicare Part D: CMS Should Monitor Effects of Rebates on Plan Formularies and Beneficiary Spending
    GAO-23-105270
      Published:   Sep 5, 2023
. 
        Publicly Released:   Sep 5, 2023
.
    Medicare beneficiaries can have prescription drugs covered via private insurance plans participating in the Medicare Part D program. Premiums and drug costs vary by plan, as do plans' lists of covered drugs—known as "formularies." Drug makers may give plans rebates in exchange for preferred placement over competitors on formularies. The rebates may lower plan premiums, but they don't reduce beneficiaries' payments for the drugs. We...
      **Released on   Aug 24, 2023**
          Nuclear Power: NRC Needs to Take Additional Actions to Prepare to License Advanced Reactors
    GAO-23-105997
      Published:   Jul 27, 2023
. 
        Publicly Released:   Aug 24, 2023
.
    The Nuclear Regulatory Commission licenses nuclear reactors. In the coming years, the agency expects an increase in licensing applications for advanced nuclear reactors that may provide benefits like faster and cheaper electricity production. NRC has begun updating its regulations and processes to include these reactors—but has had difficulty hiring and retaining the staff needed to license them. Although NRC has offered recruitment and retention incentives...
      **Released on   Jul 28, 2023**
          Over-the-Counter Drugs: Status of FDA's Implementation of Exclusivity Provisions in the CARES Act
    GAO-23-106570
      Published:   Jul 28, 2023
. 
        Publicly Released:   Jul 28, 2023
.
    In July 2020, we reported that the CARES Act gave the Food and Drug Administration new tools to regulate over-the-counter drugs like sunscreen and cold medicine. It included a provision offering 18 months of exclusive marketing rights for drugs with new uses or innovative active ingredients. As of May 2023, however, no companies had requested approval for over-the-counter drug innovations. FDA is still preparing to...
      **Released on   Jul 13, 2023**
          Regenerative Medicine: Therapeutic Applications, Challenges, and Policy Options
    GAO-23-105430
      Published:   Jul 13, 2023
. 
        Publicly Released:   Jul 13, 2023
.
    Regenerative medicine restores or replaces human cells, tissues, or organs affected by disease. This may eventually help cure many conditions that are currently considered difficult to treat. For example, a patient's own cells could be used to create a personalized organ, which could eliminate the possibility that a patient's body will reject a donated organ. However, there are challenges with developing regenerative medicine technologies. We...
      **Released on   May 22, 2023**
          Priority Open Recommendations: Department of Agriculture
    GAO-23-106456
      Published:   May 12, 2023
. 
        Publicly Released:   May 22, 2023
.
    Each year, we make more than 1,000 recommendations to help the federal government save money, address issues on our High Risk List , and significantly improve government operations. This letter to the U.S. Department of Agriculture outlines 12 open recommendations that it should prioritize. For example, one recommendation was for USDA to analyze different options to help farmers and ranchers prepare for the impacts of...
      **Released on   Mar 15, 2023**
          Generic Drugs: Stakeholder Views on Improving FDA's Information on Patents
    GAO-23-105477
      Published:   Mar 15, 2023
. 
        Publicly Released:   Mar 15, 2023
.
    The Orange Book is a list of FDA-approved drugs. It helps generic drug companies identify when patents for brand name drugs will expire so they can market generic equivalents. For makers of brand name drugs, listing patents gives them time to resolve patent disputes before a generic can be offered for sale. Views varied, but some stakeholders had concerns that certain patent listing practices can...
      **Released on   Mar 10, 2023**
          Drug Manufacturing: FDA Should Fully Assess Its Efforts to Encourage Innovation
    GAO-23-105650
      Published:   Mar 10, 2023
. 
        Publicly Released:   Mar 10, 2023
.
    The Food and Drug Administration has promoted advanced manufacturing—i.e., innovative technologies—as a way to address drug shortages. For example, it approved 2 drugs made using advanced manufacturing to treat a COVID-19 complication. But we found that few drugs are manufactured using this technology, and the FDA doesn't know if all of its efforts to increase the technology's use are working. The agency hasn't formalized performance...
      **Released on   Feb 16, 2023**
          Institutional Review Boards: Actions Needed to Improve Federal Oversight and Examine Effectiveness
    GAO-23-104721
      Published:   Jan 17, 2023
. 
        Publicly Released:   Feb 16, 2023
.
    Institutional Review Boards (IRBs) assess the ethics and safety of research studies involving human subjects, such as behavioral studies or clinical trials for new drugs or medical devices. Health and Human Services oversees about 2,300 U.S.-based IRBs through routine or for-cause inspections to assess if they are following federal laws when reviewing research. But few IRBs are inspected. For example, one HHS agency aims to...
      **Released on   Jan 31, 2023**
          Pediatric Cancer Studies: Early Results of the Research to Accelerate Cures and Equity for Children Act
    GAO-23-105947
      Published:   Jan 31, 2023
. 
        Publicly Released:   Jan 31, 2023
.
    In the U.S., pediatric cancer is among the most deadly childhood diseases—but relatively few drugs are approved to treat it. To facilitate the development of safe new drugs to treat children, the RACE Act requires developers of certain adult cancer drugs to submit plans to also study their use in pediatric patients. This has increased the number of planned pediatric cancer studies, but it's too...
      **Released on   Dec 15, 2022**
          CARES Act: Structural Characteristics That Can Help Insulate HHS Agencies against Potential Political Interference
    GAO-23-105415
      Published:   Dec 15, 2022
. 
        Publicly Released:   Dec 15, 2022
.
    Four HHS agencies had key roles in the federal COVID-19 response. Our prior reports noted shortcomings to that response, including possible political interference. Some characteristics of an agency's structure may affect how insulated it is from potential political interference, including How many political appointees it has Whether it has active advisory committees with experts to guide decisions If agency officials have fixed terms These characteristics...
      **Released on   Nov 8, 2022**
          Food Safety: FDA Oversight of Substances Used in Manufacturing, Packaging, and Transporting Food Could Be Strengthened
    GAO-23-104434
      Published:   Nov 8, 2022
. 
        Publicly Released:   Nov 8, 2022
.
    Food processing and packaging can introduce non-food substances, such as those used to greaseproof paper takeout containers, into food. Some of these substances may pose health risks. FDA reviews information on the safety of such substances before their first use. As new information becomes available that suggests a substance may pose a health risk, FDA will occasionally reevaluate it based on the new information. But...
    
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