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Protecting Public Health through Enhanced Oversight of Medical Products

This information appears as published in the 2015 High Risk Report.

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Millions of medical products are used daily by Americans 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 our 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, we have found that challenges remain.

Protecting Public Health through Enhanced Oversight of Medical Products

FDA has demonstrated leadership commitment toward the enhanced safety and efficacy of drugs and medical devices, most notably through organizational changes and special initiatives. For example, it has established a new office to emphasize its commitment to confronting the challenges of globalization and relocated its Drug Shortage staff to a more prominent position in the agency. FDA's initiatives focused on improved oversight of medical devices have strengthened its management of device recalls and led to progress in its reclassification of device types based on risk. However, globalization and shortages of medically necessary drugs remain pressing concerns. It is unclear whether FDA has the financial resources and staff to effectively address globalization. In addition, FDA's monitoring of drug shortages requires its continued attention.

FDA has made substantial progress in addressing the concerns we raised regarding its oversight of medical device recalls and the implementation of the Safe Medical Devices Act of 1990. In recognition of the agency's significant strides in these two areas, we have narrowed the scope of our high-risk designation. FDA has met all five criteria—demonstrating strong leadership commitment, ensuring sufficient capacity, developing both specific action plans and effective monitoring tools, and demonstrating progress—for having the high-risk designation removed for these two areas. The agency has greatly improved its oversight of medical device recalls by fully implementing all of the recommendations made in our 2011 report on this topic. It has also made considerable progress in fulfilling the requirements of the Safe Medical Devices Act of 1990, as we recommended in 2009.

Medical Device Recalls

Medical Device Recalls

Medical device recalls provide an important remedial action that can mitigate the risk of serious health consequences associated with a defective or unsafe medical device. In 2011, we reported on gaps in FDA’s oversight of these recalls and made recommendations to the agency to enhance its oversight of medical device recalls. The Food and Drug Administration Safety and Innovation Act (FDASIA) required the agency to implement these recommendations. FDA demonstrated its leadership commitment to enhanced oversight and initiated a recall improvement project. The agency developed—and has now implemented—a detailed action plan to improve the recall process.

FDA proved it had the capacity to initiate change and has fully implemented all of our recommendations. For example, as we recommended, FDA took steps to ensure the consistent application of its recall procedures by its investigatory staff and developed explicit criteria and set thresholds for determining whether recalling firms have performed effective corrections or removals of defective products. FDA also established a standardized recall termination review process that utilizes a template to document that recalls were effectively completed based on its new explicit criteria. The template also ensures that the criteria are routinely applied. FDA has demonstrated clear progress in implementing this process—it reported that it has documented the termination of every Class I, or highest-risk, recall using this template since January 1, 2013.

In addition, as we also recommended, FDA began a recall monitoring program and, in March 2014, issued a report analyzing medical device recall data that includes detailed information on recalls from fiscal year 2003 through fiscal year 2012. This report provides a systematic analysis of recall information. The report states that FDA will continue to use recall information to better inform decision making across the total product life cycle, provide guidance to industry, and target needed interventions. In addition, FDA’s report notes that review and analyses of these data will help to guide both it and industry in strategically focusing on efforts that will improve the quality of medical devices and thereby improve patient outcomes—another indicator of the agency’s commitment to enhancing its oversight of medical device safety.

Safe Medical Devices Act of 1990

Implementing Safe Medical Devices

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 lower-risk class or establishing a schedule for such devices to be reviewed through its most stringent premarket approval process. Although FDA determined that more than 100 device types were subject to this provision, we found that the agency had never established a timetable for its reclassification or rereview process. We reported that FDA’s progress was slow and, as a result, 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 entered the market through FDA’s less stringent premarket review process. In 2009, we recommended that FDA expedite its implementation of the act.

FDA has since demonstrated commitment, capacity, and progress in implementing our recommendation. For example, FDA proved it was committed to progress in late 2009 when it established a new initiative for the 26 device types that still needed to be evaluated for reclassification as a lower-risk device or be reviewed through the most stringent premarket approval process. Additionally, in both 2011 and 2012, FDA’s Center for Devices and Radiological Health made the determination to either reclassify these devices or review them through the most stringent review process a strategic priority. FDA also began monitoring its progress and posting the status of its reviews on its website. Later, in July 2012, the enactment of FDASIA provided FDA authority to reclassify a device by administrative order rather than through notice and comment rulemaking, which FDA said would ultimately streamline the reclassification process. In August 2014, FDA reiterated its commitment to expeditious action. By that time, the agency had made considerable progress, having made reclassification determinations for 12 of the 26 device types. Although FDA still has more work to do, it has taken steps to begin work on all of the 14 remaining device types. It has also developed an action plan with a goal of fully implementing the provisions of the Safe Medical Devices Act by the second quarter of calendar year 2015.

FDA is also making progress in two areas where we have identified shortcomings in the agency’s oversight of two threats to public health—globalization and drug availability. We recognize that FDA cannot resolve the persistent problems associated with these challenges alone. Thus far, FDA has met two of the criteria for having the high-risk designation removed for these two areas—demonstrating leadership commitment and developing action plans. However, FDA needs to meet the remaining three criteria. Specifically, the agency has not shown it has sufficient capacity to address these challenges and its monitoring still warrants greater attention. FDA also needs to demonstrate sustained progress in both areas.

Response to Globalization

Response to Globalization

As the world has become more interconnected, new threats to the safety and effectiveness of our medical products have grown. The U.S. has become increasingly dependent on global markets to supply the drugs and devices used daily. According to FDA, nearly 40 percent of finished drugs and about 50 percent of all medical devices are made overseas, with products coming from more than 150 countries, including those with less sophisticated regulatory systems. FDA also reports that approximately 80 percent of the manufacturers of active pharmaceutical ingredients used in the United States are located elsewhere. Import lines from emerging markets, including Mexico, India, China, and Thailand, have increased faster between 2002 and 2009 than lines from developed markets. China has the fourth-highest volume of exports to the U.S. of medical equipment and the largest number of foreign, FDA-registered, drug manufacturing establishments, followed by India. The rapid pace and magnitude of globalization has complicated FDA’s efforts to ensure that the medical products we need are of high quality.

FDA has engaged in a variety of activities in response, but the challenges are many, the stakes are high, and progress, while steady, is far from rapid. We have had long-standing concerns with FDA’s foreign drug inspection program. In 2008, we reported that FDA inspected relatively few foreign establishments each year. We also pointed out that FDA has not utilized its risk-based process to select foreign establishments for inspection to the extent it had for selecting domestic establishments. Since then, FDA had increased the number of foreign establishments it inspects each year. In addition, FDASIA directed FDA to take a risk-based approach to inspecting both foreign and domestic drug manufacturing establishments, consistent with our 2008 recommendation. However, foreign inspections are costly and FDA cites resources as a concern. FDA has stated that it may not have the capacity to implement our recommendation, which would limit its ability to monitor medical products from overseas. It estimates that it may not be able to fully implement this provision until fiscal year 2017. The agency is also continuing to fine-tune its risk-based model for selecting establishments to inspect, but the time frame for completing this task is unclear.

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 emphasizes the agency’s leadership 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. The agency’s leadership commitment was further made evident with the release of a report in 2012 on its strategies for responding to globalization. Also, in September 2014, FDA published its strategic priorities for fiscal years 2014 through 2018, which features its desire to expand its regulatory presence and partnerships overseas to build a stronger, more secure global product safety net.

FDA’s foreign offices, overseen by the Office of International Programs, continue to play a part in the agency’s response to globalization. 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. The agency increased its presence overseas by opening new offices and now has established a permanent presence overseas in 12 foreign posts, including China, Europe, India, Latin America, the Middle East and South Africa. Among other things, these offices help FDA build partnerships with its foreign regulatory counterparts and industry by providing enhanced opportunities for cooperation and capacity building. They also perform intelligence gathering, foster information sharing with FDA headquarters, and provide a platform for inspection of foreign establishments.

However, while FDA’s Office of International Programs has advanced its strategic planning process, it has yet to develop a set of performance goals and measures that can be used to monitor the long-term contributions of the overseas offices and demonstrate progress in improving the regulation and oversight of imported medical products, as we recommended in 2010. In addition, the agency continues to face capacity constraints, as it struggles to find officials to staff its overseas offices. Further, our 2010 recommendation that it develop a strategic workforce plan to ensure the agency is able to recruit and retain staff with necessary experience remains to be addressed.

Finally, collaboration with FDA’s foreign counterparts is a key component of its response to globalization. FDA is working to harmonize standards, leverage resources, and conduct joint inspections of foreign manufacturing establishments. FDASIA increased FDA’s ability to partner with foreign regulatory authorities to leverage resources through increased information sharing and recognition of foreign inspections. FDA is exploring using this new ability to build and strengthen its regulatory capacity. The agency reports it now has more than 60 agreements with foreign counterparts to share certain information in inspection reports and other nonpublic information that can help it make better decisions about the safety of foreign products. In addition, according to FDA, it has worked with Canada, India, and the European Union to inspect facilities in countries that supply active pharmaceutical ingredients and finished drugs. This could help improve the agency’s monitoring and enhance its capacity to oversee medical product safety around the world.

Drug Availability

Drug Availability

Over the last decade, an increasing number of prescription drugs—including life-saving and life-sustaining drugs—has been in short supply, preventing health care providers and patients from accessing medications that are essential for treatment. In 2011 we reported on drug shortages and recommended that FDA take several steps to enhance its ability to respond to such shortages. For example, we recommended that, to improve its capacity, FDA assess the allocation of its resources to improve the agency’s ability to respond to drug shortages. FDA has implemented this recommendation and increased the number of personnel devoted to shortages. FDA also elevated the office of its drug shortage staff to a more prominent position in the agency, demonstrating its commitment to this issue. It also has assigned drug shortage coordinators in each of its 20 district offices. These coordinators have helped increase capacity by bringing drug shortage-related concerns to light earlier, such as inspections citing violations of good manufacturing practices at establishments producing a large volume of drugs. FDA has also expanded its ability to respond with additional experts from throughout the agency. In addition to the drug shortage staff, FDA estimates that an average of 25 additional staff members work on any given shortage, including staff from the clinical review divisions, chemistry groups, compliance staff, and others as required based on the expertise needed to address the shortage. We issued a second report in 2014 and found that, while shortages have persisted, FDA had prevented more potential shortages in the prior 2 years by improving its responsiveness by, for example, working with manufacturers to increase production.

In addition, FDASIA further strengthened the agency’s ability to respond to shortages. We suggested in 2011 that Congress consider establishing a requirement for manufacturers to report to FDA any changes that could affect the supply of their drugs. FDASIA contains a provision requiring 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. FDA reported that there was a sizeable increase in notifications from manufacturers following the law’s enactment in 2012. FDA also noted that this provision has allowed the agency to take action sooner and has helped the agency become more proactive and successful in its efforts. We found that FDA was able to prevent more shortages as a result. Additionally, in accordance with another provision in FDASIA, FDA has developed a Drug Shortages Task Force representing multiple disciplines, centers, and offices with the agency, which has enhanced the agency’s capacity in multiple ways. For example, the task force has helped the agency revise internal policies and procedures and facilitate coordination across the agency on issues related to drug shortages.

In 2011, we reported that, despite the recent increase in drug shortages, FDA had not substantially changed the priority it places on its response to drug shortages. We recommended that FDA’s strategic plan articulate goals and priorities for maintaining the availability of all medically necessary drugs. FDASIA also required FDA to issue a strategic plan to enhance the agency’s ability to prevent and mitigate shortages. FDA issued this strategic plan in October 2013. This action plan focuses on two goals. First, it emphasizes strengthening FDA’s ability to respond to notices of a disruption in supply, including improving mitigation tools. Second, it stresses developing long-term prevention strategies to address the underlying causes of supply disruptions and prevent drug shortages. The plan outlines the actions FDA is taking—or plans to take—to strengthen and expand its efforts and identifies potential actions for other stakeholders to consider. FDA reported that the actions outlined in its Strategic Plan will improve the agency’s ability to address drug shortages. In addition, in September 2014, FDA published its strategic priorities for fiscal years 2014 through 2018, which emphasizes the agency’s continued commitment to preventing and responding to drug shortages.

Yet, drug shortages continue to remain a serious public health concern and we recognize that FDA cannot resolve this concern alone. FDA has demonstrated progress in addressing and preventing shortages, including through its use of new authorities granted by FDASIA. However, it can do more, including implementing recommendations we made in 2011. We continue to believe that FDA needs results oriented outcome performance measures to assess and quantify its goals and response to drug shortages. In addition, we remain concerned with shortcomings in FDA’s management of its drug shortage data. In our 2014 report, we noted that FDA has not created policies or procedures governing the management of the data and does not perform routine quality checks. Such shortcomings could ultimately hinder FDA’s efforts to understand the causes of specific shortages as well as undermine its efforts to prevent them from occurring. In addition, FDA has not conducted routine analyses of the data to proactively identify and evaluate the risks of drug shortages. We believe that, to enhance its monitoring, FDA needs to do more to ensure the reliability of the information it gathers and periodically assess these data to proactively identify drug shortage risks and take preventive measures as quickly as possible. We will continue to assess FDA’s progress in this area in our ongoing work examining drug shortages.

Congressional Action

In addition to FDA’s efforts, action taken by Congress since our last High-Risk Series report was issued should help the agency better protect public health. Specifically, the Drug Quality and Security Act (DQSA), enacted in November 2013, contains provisions to address drug safety concerns that we reported on in 2013—the safety and security of the pharmaceutical supply chain and the regulation of compounded drugs.

The pharmaceutical supply chain has grown increasingly complex. Networks of handlers, suppliers, and middlemen have made it difficult to trace an ingredient back to its source. At every step in global supply chain networks—from raw materials and other ingredients, to manufacture, storage, sale, and distribution—there are opportunities for a product to be improperly formulated or packaged, contaminated, diverted, counterfeited, or adulterated. The breakdown of the supply chain has led to public health crises involving contaminated heparin, a common blood-thinner, in 2008 and the distribution of counterfeit Avastin, a cancer treatment, in 2012 and 2013. In July 2013 we reported on the hazard of one component of the supply chain—Internet pharmacies, many of which are fraudulent enterprises. Although the exact number of these “rogue” Internet pharmacies is unknown, most operate from abroad. They may sell drugs that are expired; improperly labeled, stored, or shipped; or are counterfeits—unauthorized versions—of other drugs. These drugs may be manufactured under conditions that do not meet FDA standards, including unsanitary and unsterile conditions and have been found to contain dangerous contaminants, such as rat poison. The threat they pose becomes all the more worrisome in light of an FDA survey which found that nearly 1 in 4 adult U.S. Internet consumers have purchased prescription drugs online.

To improve the safety of drugs, Congress enacted DQSA, which contains a variety of provisions designed to make it more difficult for unscrupulous members of the pharmaceutical supply chain to operate. The new law requires the Secretary of Health and Human Services to facilitate the establishment over the next ten years of an electronic, interoperable system to trace prescription drug products through the pharmaceutical supply chain. In the shorter term, the law requires members of the supply chain—drug manufacturers, wholesalers, repackagers, and dispensers—to comply with new requirements to facilitate the tracking and tracing of drugs through the supply chain. Specifically, manufacturers and repackagers must place standardized product identifiers on certain prescription drug products. Manufacturers, wholesale distributors, repackagers, and dispensers, are also required to implement a system to help ensure products are not counterfeit or otherwise unfit for distribution. The law also prohibits them from purchasing from or selling drugs to entities that do not meet certain requirements. FDA is taking steps to implement the provisions of this law.

DQSA also includes provisions aimed at ensuring the safety of compounded drugs. Traditionally, a drug is compounded through the process of mixing, combining, or altering ingredients to create a customized drug tailored to the medical needs of an individual patient upon receipt of a prescription. For example, a pharmacist may tailor a drug for a patient who is allergic to an ingredient in a manufactured drug. Compounding is an integral part of the pharmacy profession and is practiced in a variety of settings, including hospital, community, and chain drug store pharmacies. However, compounded drugs—especially compounded sterile drugs—pose special risks of contamination if made improperly. An outbreak of fungal meningitis in 2012 linked to contaminated compounded drugs resulted in more than 60 deaths and hundreds of people becoming ill. Following this outbreak, concerns were raised that some pharmacies were producing large quantities of compounded drugs without prescriptions for individual patients, and without meeting safety and other requirements with which manufacturers must comply, and selling those drugs to facilities in multiple states. This outbreak also raised concerns about state and federal oversight of drug compounding. While FDA is responsible for overseeing drug manufacturers, compounding performed in pharmacies is traditionally regulated by state pharmacy regulatory bodies.

In July 2013, we reported that FDA’s authority to oversee drug compounding was unclear as a result of conflicting federal court decisions regarding the applicability of the drug compounding provisions in the Food, Drug, and Cosmetic Act (FDCA). FDCA exempts compounded drugs meeting certain criteria from drug approval, certain labeling, and good manufacturing practice requirements. We recommended that Congress consider clarifying FDA’s authority to regulate entities that compound drugs. DQSA clarifies that the FDCA’s drug compounding provisions apply to drug compounding throughout the country. The law also established a new category of entities, known as “outsourcing facilities.” Outsourcing facilities that register with FDA and provide information to the agency about the products they compound are exempt from FDA drug approval and certain labeling requirements. However, they are required to comply with current good manufacturing practices, report semiannually on the drugs they are compounding, submit adverse event reports to the agency as appropriate, and clearly label the compounded drugs they manufacture as such. FDA has taken steps to implement these provisions. For example, FDA has issued draft guidance on registration and information reporting for entities that intend to register as outsourcing facilities. Since the 2012 outbreak, FDA has also increased inspections of compounding pharmacies in response to reports of serious adverse events and quality problems. In addition, it has inspected other pharmacies with deficient sterile compounding practices that the agency has proactively identified.

While DQSA should improve oversight of drug compounding, we remain concerned about FDA’s oversight in this area. We reported in 2013 that FDA lacks timely and reliable information to oversee the entities that compound drugs. Specifically, FDA’s inspection database cannot identify all of the agency’s inspections of compounding pharmacies or the final classification of inspection results for all of the inspections. In addition, we found that there were high-risk compounding pharmacies that may have registered with FDA to market themselves as “FDA registered.” This may lead some purchasers to assume that FDA has inspected or approved their compounded drugs which, according to FDA officials, is generally not the case. We will continue to monitor FDA’s efforts to improve its data collection and regulation of compounding.

FDA has made considerable progress in the last 2 years, particularly in ensuring the safety and effectiveness of medical devices. FDA has developed meaningful action plans and has already shown—and must sustain—strong leadership in addressing management challenges. While these action plans and strong leadership are two of the five criteria an agency must meet for the high-risk designation to be removed, the oversight of medical products remains on our High Risk List because more needs to be done before the remaining three criteria can be met in the areas of globalization and drug availability. FDA needs to demonstrate that it has the capacity to address the challenges we have identified, along with effective monitoring strategies. In addition, FDA must demonstrate clear and sustained progress in implementing these measures. Finally, FDA should implement our prior recommendations to resolve new and previously identified concerns. Specifically, FDA needs to:

  • conduct more inspections of foreign establishments manufacturing medical products for the U.S. market and utilize its 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;
  • establish a set of performance goals and measures that can be used to demonstrate contributions of its overseas offices to long-term outcomes related to the regulation of imported products and develop a strategic workforce plan to ensure the agency is able to recruit and retain staff with necessary experience;
  • strengthen its ability to prevent, mitigate, and resolve drug shortages by systematically tracking data on shortages; ensure the accuracy of the data it collects; conduct periodic analyses of the data to proactively identify trends, clarify causes, and resolve problems before drugs go into short supply; and develop relevant results-oriented performance metrics to gauge the agency’s response to shortages; and
  • take steps to consistently collect reliable and timely information on inspections and enforcement actions associated with compounded drugs, and collect information that clearly differentiates manufacturers of FDA-approved drugs that are inspected for compliance with good manufacturing practices from those entities that are compounding drugs that are neither FDA approved nor routinely inspected.
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