What We Found
The Food and Drug Administration needs to increase monitoring of medical products manufactured overseas and improve planning for drug shortages.
Since our 2019 High-Risk Report, our assessment of efforts to address ratings for all five criteria remains unchanged. The Food and Drug Administration (FDA) continues to demonstrate leadership support for improving its oversight of medical products for both the globalization and drug availability segments. However, the agency has not fully met the remaining criteria.
In the globalization segment of this high-risk area, the capacity criterion has regressed from met to partially met. In the drug availability segment, the five criteria remain unchanged. FDA’s effective oversight will be especially important to ensuring the availability of medical products needed to fight the Coronavirus Disease 2019 (COVID-19) pandemic.
Response to Globalization
Since our 2019 High-Risk Report, ratings in this segment for four criteria remain unchanged. However, the capacity criterion regressed to partially met.
Leadership commitment: met. FDA met this criterion in 2015. The agency continues to demonstrate leadership commitment by (1) reorganizing its office dedicated to confronting the challenges of globalization in 2019, and (2) releasing a new 5-year strategic plan in March 2020.
Continued commitment from leadership will be important for FDA’s ability to respond to ongoing and evolving challenges. For example, the COVID-19 pandemic affected FDA’s ability to conduct inspections of foreign drug manufacturers, limiting a critical source of information about the quality of drugs manufactured for the U.S. market. Addressing its challenges will require sustained leadership focus.
Capacity: partially met. FDA now partially meets this criterion—regressing from met in our 2019 High-Risk Report. From fiscal years 2012 through 2016, FDA conducted an increasing number of inspections of foreign drug manufacturing establishments. However, in fiscal years 2017 and 2018, these inspections decreased.
FDA officials attributed this decrease to, in part, vacancies in the number of investigators available to conduct inspections. In June 2020, we reported that FDA had vacancies among each of the groups of investigators who conduct foreign inspections. For example, within its foreign offices in China and India, about one-third of its drug investigator positions were vacant.
Further, in March 2020, FDA announced that, due to COVID-19, it was postponing almost all inspections of foreign establishments. While FDA indicated it has other tools to ensure the safety of the U.S. drug supply, the lack of foreign inspections removes a critical source of information about these drugs. As of January 2021, FDA did not have an expected date for resuming regular foreign inspections in all countries.
Action plan: met. FDA met this criterion in 2015 and continues to take steps to meet it. In March 2020, the agency released a 5-year strategic plan to guide the activities of the office that overseas its global activities. It also partnered with European regulators to leverage their resources. By July 2019, FDA had determined that 28 European regulators were capable of conducting inspections that meet FDA’s requirements. In fiscal year 2020, during the postponement of inspections, FDA increased its reliance on inspections from these regulators in lieu of conducting its own inspections.
Monitoring: partially met. FDA has taken steps to better monitor its program for inspecting foreign establishments by improving the accuracy and completeness of information on foreign establishments subject to inspection. However, despite these steps, in June 2020, we reported that data challenges continued to make it difficult for FDA to accurately identify foreign establishments subject to inspection.
Specifically, since 2017, FDA pursued an initiative to inspect approximately 1,000 foreign establishments lacking an inspection history. FDA completed this initiative, but, in doing so, it found that a sizeable percentage of the establishments in its data system did not have to be inspected by FDA (e.g., about 40 percent of those assigned to its office in China in fiscal years 2017 and 2018). For example, some were not subject to inspection because it turned out they did not actually manufacture drugs for the U.S. market. FDA also has not fully developed measures allowing it to systematically track how its foreign office activities contribute to drug safety outcomes.
In addition, FDA has not yet completed its efforts to develop performance measures for the foreign offices and assess their effectiveness. In August 2020, FDA reported that it was revising and updating its measures and its approach to evaluating impact to align with the strategic plan.
Demonstrated progress: partially met. FDA has taken steps to respond to globalization, including (1) improving the accuracy and completeness of its information on foreign manufacturers, and (2) deciding it will no longer allow more than 5 years to elapse between inspections at a specific establishment.
However, in June 2020, we reported that FDA continued to face challenges when conducting foreign inspections that raised questions about their equivalence to domestic inspections. In particular, while domestic inspections are almost always unannounced, officials said that FDA generally preannounces foreign inspections about 12 weeks in advance, which may give manufacturers the opportunity to fix problems. These challenges are further complicated by the pause in inspections resulting from the COVID-19 pandemic. FDA must address these challenges and demonstrate that it can maintain its oversight of drugs manufactured overseas.
Since our 2019 High-Risk Report, ratings for all five criterion in this segment remain unchanged. FDA continues to meet the criteria for leadership commitment and for monitoring.
Leadership commitment: met. In the 2015 High-Risk Report, we recognized FDA demonstrated leadership commitment to drug availability by (1) issuing a strategic plan for preventing and mitigating drug shortages, and (2) including in its strategic priorities the agency’s ability to respond to drug shortages.
FDA’s commitment to addressing this public health concern continues to be strong, as evidenced by the continued meeting of its drug shortages task force that started in 2013. Additionally, FDA established an interagency task force in July 2018 to identify the root causes of drug shortages and provide solutions, which culminated in an October 2019 report that offered recommendations for FDA and others.
Capacity: partially met. As noted in the 2019 High-Risk Report, FDA improved its capacity to respond to drug shortages, but the agency alone cannot resolve these shortages. In September 2020, FDA described efforts that it was taking to promote the use of new manufacturing techniques that have the potential to shorten production times and improve the efficiency of manufacturing processes.
In addition, the October 2019 report from FDA’s Drug Shortages Task Force included recommendations for industry, such as to promote contracting practices that would help ensure a more reliable supply of medically important drugs.
Beyond drug shortages, FDA has also faced oversight challenges that could affect the availability of drugs. For example, FDA has reported that (1) it has not had sufficient resources to adequately regulate over-the-counter drugs (e.g., cough and cold medications); and (2) a lengthy regulatory process has hindered the availability of new drug ingredients to the U.S. market. Consequently, the agency noted it has not allowed the marketing of many new over-the-counter drugs or made timely changes to existing over-the-counter drugs based on emerging safety issues or evolving science.
In March 2020, FDA received additional statutory authorities, including the authority to collect user fees from manufacturers of over-the-counter drugs, that officials said could allow FDA to address identified safety risks in a more timely and efficient manner. However, FDA officials said it will take time before FDA is able to fully realize any benefits that might result from these changes. For example, according to FDA, it generally takes 2 years for any newly hired FDA staff to complete training and be fully effective in reviewing scientific information related to the regulation of over-the-counter drugs.
Action plan: partially met. In October 2019, FDA’s Drug Shortages Task Force examined the root causes of drug shortages and made recommendations for FDA and others. However, FDA still has not used the drug shortages data it collects to analyze trends or identify patterns to help predict future shortages to assist with managing efforts. In August 2020, FDA reported it had begun modeling efforts to explore the feasibility of predicting future drug shortages and would identify next steps after it completes these initial efforts.
We also reported on other opportunities FDA has to increase drug availability. Specifically, in August 2019, we reported that in its review of generic versions of brand name drugs, FDA needed to (1) address inconsistencies in written comments provided by FDA reviewers that could lead to longer reviews, and (2) assess the extent to which actions by brand-name drug companies affect the approval of generic versions. In December 2020, FDA indicated it was taking steps to address both issues.
In addition, FDA still needs to take actions to address shortcomings in its broader strategic planning efforts. For example, FDA needs to engage in a strategic planning process to identify challenges that cut across each of its centers responsible for overseeing medical products and document how it will achieve measurable goals and objectives in these areas.
Monitoring: met. In the 2019 High-Risk Report, we recognized that FDA met this criterion through the consistent use of its drug shortage information system to track potential and existing shortages. The agency established formal procedures for using the system and performance measures to evaluate its ability to respond when shortages occur.
FDA has continued to issue annual reports on drug shortages data, most recently in April 2020. At the beginning of the COVID-19 pandemic, FDA asked more than 180 drug manufacturers to evaluate their supply chain for elements manufactured in China; FDA then monitored these companies for drug shortage risks.
Demonstrated progress: partially met. FDA has demonstrated progress to improve its ability to respond to drug shortages. However, FDA has not implemented all of our recommendations, such as periodically analyzing its shortage data to proactively identify risk factors.
Additionally, drug shortages remain a public health concern, and one that has been further complicated by the COVID-19 pandemic. For example, FDA temporarily authorized the emergency use of chloroquine and hydroxychloroquine to treat COVID-19. However, the products then went into shortage and were unavailable to treat other conditions (e.g., lupus and rheumatoid arthritis), for which the drug was already approved.
Millions of medical products—drugs, biologics, and medical devices—are used daily by Americans at home, in the hospital, and in other health care settings. FDA has the vital mission of protecting the public health by overseeing the safety and effectiveness of these products marketed in the United States. The agency’s responsibilities begin long before a product is brought to market and continue after FDA approves a product, regardless of whether it is manufactured in the United States or abroad.
FDA has been confronted with multiple challenges, including (1) rapid changes in science and technology, (2) globalization as many products are manufactured abroad, (3) unpredictable public health crises, (4) an increasing workload to ensure medical product availability, and (5) the continuing need to monitor the safety of thousands of marketed medical products. The oversight of medical products was added to our High-Risk List in 2009 because these obstacles threatened to compromise FDA’s ability to protect public health. While progress has been made, FDA continues to face these challenges as well as the additional challenge of the COVID-19 pandemic.
Response to Globalization
Since we added this area to our High-Risk List, we have made numerous recommendations related to the agency’s response to globalization.
- As of December 2020, two recommendations remain open related to the development of performance measures and assessing the effectiveness of the foreign offices.
- FDA should also ensure all establishments are inspected at an appropriate frequency and take steps to address the staffing and other challenges associated with inspecting foreign establishments. The COVID-19 pandemic has exacerbated some of these challenges, making continued commitment from leadership especially important.
Since we added this area to our High-Risk List, we have made numerous recommendations related to drug availability, three of which were made since the last High-Risk Report in March 2019. As of December 2020, nine recommendations remain open. Although FDA alone cannot guarantee drug availability, the agency can take important steps to help ensure that safe and effective drugs are accessible to patients. FDA should implement our recommendations, including to
- conduct periodic analyses to assess drug shortage information to proactively identify risk factors for potential drug shortages;
- take additional steps to address inconsistency in its written comments to generic drug application sponsors that can lead to longer reviews; and
- plan strategically to identify challenges that cut across FDA’s multiple centers overseeing medical products, and document how the agency will achieve measurable goals and objectives in these areas.
COVID-19: Federal Efforts Accelerate Vaccine and Therapeutic Development, but More Transparency Needed on Emergency Use Authorizations
Over-The-Counter Drugs: Information on FDA's Regulation of Most OTC Drugs
Drug Safety: COVID-19 Complicates Already Challenged FDA Foreign Inspection Program
Generic Drug Applications: FDA Should Take Additional Steps to Address Factors That May Affect Approval Rates in the First Review Cycle
Drug Safety: FDA Has Improved Its Foreign Drug Inspection Program, but Needs to Assess the Effectiveness and Staffing of Its Foreign Offices