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Millions of medical products are used by Americans on a daily basis at home, in the hospital, and in other health care settings. The Food and Drug Administration (FDA) has the vital mission of protecting the public health by overseeing the safety and effectiveness of these products—drugs, biologics, and medical devices—marketed in the United States. The agency’s responsibilities begin long before a product is brought to market and continue after a product’s approval, regardless of whether it is manufactured here or abroad. The importance of FDA’s role in ensuring our citizens’ well-being cannot be overstated. In recent years, FDA has been confronted with multiple challenges. Rapid changes in science and technology, globalization, unpredictable public health crises, an increasing workload, and the continuing need to monitor the safety of thousands of marketed medical products have strained the agency’s resources. The oversight of medical products was added to GAO’s High Risk List in 2009 because FDA was facing a variety of difficulties that threatened to compromise its ability to protect the public health. While progress has been made, GAO has found considerable challenges remain.

In recent years, GAO has identified a variety of weaknesses in FDA’s oversight of medical products. It is important to note that FDA has made positive strides in certain areas. Also, the Food and Drug Administration Safety and Innovation Act, enacted in July 2012, contains provisions that should further help the agency protect public health. However, GAO continues to believe that FDA needs to enhance its oversight of medical products. FDA needs to address persistent and previously identified shortcomings as well as problematic issues that have more recently emerged. Key issues that GAO has focused attention on include:

• Drug availability. In recent years, hospitals and health care professionals have increasingly reported nationwide shortages of drugs, including those that are life-saving and life-sustaining. These shortages directly threaten public health by preventing patients from accessing essential medications. During shortages, physicians may have to ration their supplies, delay treatments, or use alternative medications that may be less effective or pose unwanted side effects. The number of drug shortages has grown substantially and increased each year from 2006 through 2010, with a record number reported in 2010. GAO found that FDA's ability to respond to drug shortages is constrained by a variety of management challenges. For example, FDA does not systematically maintain and track data on drug shortages, and therefore cannot monitor trends. It also lacks a set of results-oriented performance metrics and has not identified drug shortages as an area of strategic importance for the agency. As a result, FDA cannot ensure that it coordinates efficiently with officials across the agency as well as manufacturers regarding prevention or mitigation strategies.
  
  While drug shortages remain a public health concern, positive steps have been taken. GAO recognized that FDA has increasingly prevented potential drug shortages from occurring when informed of a potential shortage in advance. However, GAO also noted that the agency's approach to managing shortages has been predominately reactive as it lacked authority to require manufacturers to take certain actions to prevent, alleviate, or resolve shortages, such as notifying the agency of an impending or potential shortage. In 2011, GAO suggested that Congress consider establishing a requirement for manufacturers to report to FDA any changes that could affect the supply of their drugs. The recently enacted Food and Drug Administration Safety and Innovation Act requires manufacturers of drugs that are life-supporting, life-sustaining, or used to prevent or treat debilitating diseases or conditions to notify FDA at least 6 months in advance if they either plan to discontinue manufacturing the drug or anticipate an interruption in manufacturing that is likely to lead to a meaningful disruption in the drug’s supply. In addition, FDA has begun to devote more staff and resources to its Drug Shortage Program.
• Medical device recalls. Millions of medical devices are used daily to diagnose, treat, or prevent illness. These devices range from simple tools like bandages and surgical clamps to more complicated devices such as pacemakers and artificial heart valves. If one proves to be defective or unsafe once it is in widespread use, the ramifications can be severe, potentially resulting in permanent injuries or death to patients or providers using the device. From 2005 through 2009, firms initiated 3,510 medical device recalls, an average of just over 700 per year. Just over 40 percent of the recalls involved cardiovascular, radiological, or orthopedic devices. Recalls are an important tool to mitigate the risk of serious health consequences associated with defective or unsafe medical devices. Typically, a recall is voluntarily initiated by the firm that manufactured the device and FDA oversees implementation of the recall. However, FDA has not routinely analyzed recall data to determine whether there are systemic problems underlying trends in device recalls, thus missing an opportunity to proactively identify and address the risks presented by unsafe devices.
  
  In addition, FDA's procedures for overseeing recalls are unclear. As a result, FDA officials examining similar situations sometimes reached opposite conclusions on whether recalls were conducted and completed effectively. FDA had also not established criteria, based on the nature or type of devices, for assessing whether firms corrected or removed a sufficient number of recalled devices. This is particularly important because, for many high-risk recalls—that is those FDA classified as having a reasonable probability of causing serious adverse health consequences or death—recalling firms faced challenges locating specific devices or users, and thus could not correct or remove all devices. Additionally, FDA's decisions to terminate completed recalls—that is, assess whether firms had taken sufficient actions to prevent a recurrence of the problems that led to the recalls—were frequently not made within its prescribed time frames. Finally, FDA did not document its justification for terminating recalls. Without such documentation, GAO was unable to assess the extent to which FDA’s termination process appropriately evaluated recalling firms’ corrective actions. FDA agreed with GAO’s recommendations to address its findings and the Food and Drug Administration Safety and Innovation Act, enacted in 2012, requires the agency to take action consistent with them.
• The Safe Medical Devices Act of 1990. Of considerable importance is FDA’s progress in implementing the Safe Medical Devices Act of 1990. The act requires FDA to determine the appropriate process for reviewing certain high-risk devices—either reclassifying certain high-risk medical device types to a less-risky class or establishing a schedule for such devices to be reviewed through its most stringent premarket approval process. While FDA determined that more than 100 device types were subject to this provision, the agency never established a timetable for its reclassification or re-review process. Although more than 20 years have elapsed, a significant number of high-risk devices—including device types that FDA has identified as implantable; life sustaining; or posing a significant risk to the health, safety, or welfare of a patient—still enter the market through FDA’s less stringent premarket review process. FDA has agreed that implementing this act is important and has taken the step of requiring the submission of safety and effectiveness data for the remaining 26 device types. However, progress has been slow and the agency still must issue final rules for 19 of the 26 device types and develop a realistic timetable for completing the implementation of the act.
• Globalization. Globalization has fundamentally altered the medical product manufacturing landscape. It has significantly increased reliance on medical products manufactured overseas, thus complicating FDA’s efforts to ensure that these products are of high quality. The sheer volume of medical products manufactured overseas poses significant challenges for FDA. There are thousands of foreign drug and medical device establishments registered to market their products in the United States. According to FDA, 80 percent of the active pharmaceutical ingredients in our medications come from other countries, as do 40 percent of finished dosage drugs. Imports of pharmaceutical and biological products have more than doubled since 2002 and half of all medical devices are also manufactured elsewhere. Globalization has also resulted in an increase in supply chain complexity—networks of handlers, suppliers, and middlemen—making it difficult to trace an ingredient back to its source. Although FDA inspects foreign manufacturing establishments and has increased the number of foreign establishments it inspects in recent years, it still conducts relatively few foreign establishment inspections, compared to those conducted domestically. Moreover, some foreign establishments may have never received an FDA inspection. In addition to more routine quality problems, there is growing concern with the deliberate substitution or addition of harmful ingredients to our medical products. This practice, known as economic adulteration, may be done to either increase the apparent value of products or to reduce their production costs. FDA recognizes that imported products may be particularly vulnerable to economic adulteration and has engaged many FDA offices and centers in the agency’s efforts to address this problem. However, these components have not always communicated or coordinated effectively to combat adulteration. FDA has not issued specific written guidance on how its components should approach or address their various economic adulteration efforts.
  
  It is important to recognize that FDA is taking action on a variety of fronts to meet the challenge of globalization. In 2011, FDA formed a new office—the Office of Global Regulatory Operations and Policy—comprised of its Office of Regulatory Affairs and its Office of International Programs. This reorganization was executed to emphasize the agency’s commitment to confronting the challenges of globalization and to help prepare the agency to move from being a regulator of domestic products to one overseeing a worldwide market. FDA has also expanded its presence overseas and now has offices in Africa, Asia, Europe, Latin America, and the Middle East. FDA completed a formal strategic plan to guide the activities of its foreign offices in March 2011. Through its overseas offices, FDA is working to increase its knowledge base about the standards used by foreign regulators in countries that produce medical products destined for the U.S. market. It is also providing assistance to help certain countries improve their regulatory capacities. Among other things, FDA is enhancing collaboration with its regulatory counterparts around the world to harmonize standards, leverage resources, and conduct joint inspections of foreign manufacturing establishments. FDA also implemented GAO’s 2011 recommendation to adopt a working definition of economic adulteration. Finally, recently enacted legislation should also help enhance FDA’s ability to oversee the growing number of drugs coming into the U.S. market from overseas. The Food and Drug Administration Safety and Innovation Act, enacted in 2012, directed FDA to take a risk-based approach to inspecting both foreign and domestic drug manufacturing establishments, consistent with a 2008 GAO recommendation.
• Timeliness of medical products application reviews. Reviewing applications to market new medical products in the United States is one of FDA’s major premarket responsibilities. FDA’s evaluation is needed to ensure that new products are safe and effective. To help ensure that making such products available to patients in a timely manner is a priority, FDA has established performance goals that include time frames for reviewing and acting on these applications. Although FDA is meeting most of its goals, reviews of medical device applications are taking longer. Industry and consumer groups have also raised issues related to the review process, citing matters such as insufficient communication between FDA and stakeholders, a perceived lack of predictability and consistency in reviews, and inadequate assurances regarding the safety and effectiveness of new products. FDA is engaged in activities to address many of these issues and improve the review process for both drugs and devices. It is important for FDA to continue monitoring these efforts in order to increase the efficiency and effectiveness of the review process and thereby help ensure that safe and effective products are reaching the market in a timely manner.
• Tracking medical products applications for children. The physiological differences between adults and children, challenges with recruiting pediatric participants for clinical trials, and limited economic incentives make the development of medical products for the pediatric population challenging. It is therefore imperative that FDA’s reviews of applications to market such products are closely tracked. Without available pediatric products, children may not receive treatment or may be exposed to incorrect dosing and ineffective or harmful care. Despite this, applications to market new products for children are not tracked by the agency. For example, GAO found that FDA lacks an important internal control process to ensure that the requirements contained in the Pediatric Research Equity Act are met. FDA does not track and aggregate data about applications for drugs or biologics subject to this law until near the end of the application review process. Because the law’s requirements and FDA’s goals focus on timely review and because some of the products studied may already be on the market for adult use, it is imperative that FDA have this information available to it not just at the end, but throughout the review process. FDA’s inability to track how long it has had an application or whether an application contains pediatric study results until late in the process could delay the dissemination of important information. Similarly, GAO found that FDA lacks reliable and timely information regarding devices that have been approved for use in pediatric patients. FDA therefore cannot provide policymakers, innovators, and physicians with an understanding of the extent to which medical devices are available for children and the need for future development.

The oversight of medical products remains on GAO’s High Risk List because more needs to be done to resolve both previously identified and new concerns. GAO believes that while FDA leaders are committed to addressing these weaknesses, the agency must effectively implement the necessary improvements before the high-risk designation can be removed. Specifically, FDA needs to:

• strengthen its Drug Shortage Program by assessing program resources, systematically tracking data on shortages, considering the availability of medically necessary drugs as a strategic priority, and developing relevant results-oriented performance metrics to gauge the agency’s response to shortages;
• improve oversight of medical device recalls by routinely assessing information on device recalls, clarifying procedures for conducting recalls, developing criteria for evaluating the effectiveness of recalls, and documenting the agency’s basis for terminating individual recalls;
• implement the Safe Medical Devices Act of 1990;
• conduct more inspections of foreign establishments manufacturing medical products for the U.S. market and utilize new authority to take a risk-based approach in selecting foreign drug establishments to ensure that they are inspected at a frequency comparable to domestic establishments with similar characteristics;
• emphasize the importance of timely medical product reviews, particularly for medical devices; and
• track applications to market medical products for children.

Prescription Drugs

Medical Devices

Pediatric Medical Devices

Drug Shortages

Food and Drug Administration

Drug Safety

Medical Devices

Pediatric Research

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