Protecting Public Health through Enhanced Oversight of Medical Products
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.
In recent years, FDA has been confronted with multiple challenges, including (1) rapid changes in science and technology, (2) globalization as more products are manufactured abroad, (3) unpredictable public health crises, (4) an increasing workload, 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, challenges remain related to FDA’s ability to respond to globalization and to help ensure the availability of drugs.
Since our 2017 High-Risk Report, our assessment of efforts to address ratings for all five criteria remains unchanged. FDA continues to demonstrate top 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.
While the overall rating has not changed, FDA has now met the capacity criterion for the globalization segment, as FDA increased inspections of foreign manufacturers. However, FDA must continue to take actions to monitor foreign establishments and its foreign offices to meet the criterion for demonstrating progress.
In addition, while the overall rating has not changed, FDA now meets the monitoring criterion for the drug availability segment, as it has implemented and consistently used a new drug shortages information system and established procedures for using this system. FDA also now has a procedure to evaluate its response to drug shortages. However, FDA’s capacity and lack of an action plan to address drug availability remains a challenge, including the agency not using its drug shortage information system to also analyze trends and identify patterns to help predict future shortages.
Response to Globalization
Since our 2017 High-Risk Report, ratings for one criterion improved and four remain unchanged. FDA continues to meet the leadership commitment and action plan criteria, and has now met the criterion for capacity.
Leadership commitment: met. FDA met this criterion in 2015. The agency has demonstrated leadership commitment by (1) creating an office dedicated to expanding its regulatory presence and partnerships overseas.
Capacity: met. FDA’s recent actions have met this criterion. Since 2015, FDA has consistently conducted an increased number of inspections of foreign manufacturers and selected facilities for inspection based on risk. In addition, FDA reported in 2018 that it reduced the number of foreign drug establishments with no inspection history from approximately 1,000 to just over 100. Further, the agency has also improved the capacity of its overseas offices. Overall vacancy rates for these offices have declined in recent years, though significant gaps in staffing still remain at times, while staff complete necessary processes to be stationed overseas. FDA also signed mutual recognition agreements with many European countries that have allowed it to gain capacity by using information from inspectors from these countries.
Action plan: met. FDA met this criterion in 2015. The agency has developed an action plan for building a stronger, more secure global product safety net. It also developed a plan to partner with other foreign regulatory authorities to leverage their resources. FDA has since determined that 20 foreign regulators are capable of conducting inspections that meet FDA’s requirements, and as of November 13, 2018, had reviewed 50 inspections conducted by foreign regulators.
Monitoring: partially met. In December 2016, we reported that FDA took steps to better monitor its program for inspecting foreign and domestic establishments. Since then, FDA has taken steps to improve the accuracy and completeness of information used for that program. Starting in 2017, FDA began an effort to inspect, within 3 years, all establishments for which it had no prior history of inspection. FDA has made progress in inspecting these sites and expects to complete this task in fiscal year 2019. FDA has also made progress monitoring the contributions of its overseas offices, though it has not fully developed measures that allow it to systematically track how office activities contribute to drug safety outcomes.
Demonstrated progress: partially met. FDA has taken a variety of steps to respond to globalization, including improving the accuracy and completeness of its information on foreign manufacturers, and deciding that it will no longer allow more than 5 years to elapse between inspections at a specific establishment. However, FDA must continue to demonstrate that it can sustain its capacity to conduct more inspections.
Since our 2017 High-Risk Report, ratings for one criterion improved and four remain unchanged. FDA continues to meet the criteria of leadership commitment and has now met the criterion for monitoring.
Leadership commitment: met. In the 2015 High-Risk Report, we recognized FDA demonstrated leadership commitment by issuing a strategic plan for preventing and mitigating drug shortages, and also by including the agency’s ability to respond to drug shortages in its strategic priorities. FDA’s commitment to addressing this public health concern continues to be strong, as evidenced by its recent formation of a drug shortages task force. The task force is charged with delving more deeply into the reasons for persistent shortages and seeking solutions to address their underlying causes. FDA also held a public meeting in November 2018 to obtain advice from stakeholders on ways to avert drug shortages.
Capacity: partially met. As noted in prior years, FDA improved its capacity to respond to drug shortages by increasing the number of dedicated personnel devoted to responding to drug shortages and prioritized its review of applications to market generic drugs. However, with the median time to approve prioritized generic drug applications at over a year, this approach is not an effective short-term solution.
While FDA is taking steps to address drug shortages, it is important to recognize that FDA cannot resolve them alone. In the past 2 years, several agency actions may help support industry’s capacity to prevent or mitigate shortages related to manufacturing problems. First, using the authority it was given in 2016 through the 21st Century Cures Act, FDA has awarded research grants to several universities to study continuous manufacturing. This approach has the potential to shorten production times and improve the efficiency of manufacturing processes. Second, FDA established its Emerging Technology Program to help encourage the industry to develop new technologies that may improve manufacturing and reduce the chance of supply disruptions. Through the program, industry representatives can meet with FDA staff to discuss potential concerns related to these new technologies, such as the development of ultra-long-acting oral formulations, before seeking agency approval.
However, according to FDA officials, the agency may not have sufficient resources available to ensure the availability of drugs more broadly. Specifically, in 2017, FDA noted that its resources to conduct its over-the-counter drug responsibilities were inadequate. A lengthy regulatory process has hindered the availability of new drug ingredients to the U.S. market, such as those included in sunscreen. Consequently, the agency noted that 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.
Action plan: partially met. FDA implemented a new data system in 2016 to track potential and existing drug shortages and manage its workload. While it uses this system for monitoring, FDA has not made plans to use these data to analyze trends or identify patterns to help predict future shortages to assist with managing efforts. The formation of FDA’s new drug shortages task force may provide the opportunity to plan future actions strategically. According to FDA, the task force will evaluate the reimbursement policies of the Centers for Medicare & Medicaid Services and other payers that could be making it difficult for companies to manufacture certain drugs profitably. It is also exploring ways to receive more timely information about potential supply disruptions.
Nonetheless, FDA still needs to take actions to address shortcomings in its broader strategic planning efforts related to its oversight of drugs and other medical products. Also, in May 2016, we found weaknesses in the agency’s lack of measurable goals for advancing regulatory science—the science supporting its effort to assess the safety, efficacy, quality, and performance of the products it regulates.
Monitoring: met. FDA has met this criterion through its recent actions. In June 2017, we determined while following up on open recommendations that FDA was consistently using its new drug shortage information system to track potential and existing shortages. This system remains in use for monitoring purposes. In addition, the agency established formal procedures for using the system and performance measures to evaluate its ability to respond when shortages occur. Also, in June 2018, FDA issued its annual report on drug shortages. This report contained a full year’s worth of data and provided policymakers with the ability to more closely monitor shortage information and obtain a more realistic view of this public health problem.
Demonstrated progress: partially met. FDA has implemented some of our recommendations, including consistently using its drug shortage information system to improve its ability to respond to drug shortages. However, drug shortages remain a public health concern and FDA has not fully addressed the recommendations that we have made, such as periodically analyzing its shortage data to proactively identify risk factors, and better collecting, tracking, and analyzing data related to safety of drugs after they are marketed.
Response to Globalization
Over the years 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 2018, two recommendations remain open. FDA should implement our recommendations to (1) develop performance measures and (2) assess the effectiveness of the foreign offices’ contributions by systematically tracking information to measure whether the offices’ activities specifically contribute to drug safety-related outcomes, such as inspecting facilities, issuing import alerts to block potentially dangerous products, and sending warning letters to manufacturers with significant regulatory violations. In addition to our two open recommendations, FDA should complete its efforts to inspect all establishments without an inspection history and ensure all establishments continue to be inspected at an appropriate frequency.
Over the years since we added this area to our High-Risk List, we have made numerous recommendations related to drug availability, 5 of which were made since the last high-risk update in February 2017. As of December 2018, 12 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;
- develop comprehensive plans, including goals and time frames, to correct problems with its data for monitoring safety after a product is on the market, and ensure that these data can be easily used for oversight;
- plan strategically to identify challenges that cut across FDA’s multiple centers that oversee medical products, and document how the agency will achieve measurable goals and objectives in these areas; and
- develop and document measurable goals, such as targets and time frames, for FDA’s regulatory science efforts so it can consistently assess and report on the agency's progress in regulatory science efforts.
GAO-18-80: Published: Dec 14, 2017. Publicly Released: Jan 16, 2018.
Generic drugs can save consumers and the health care system billions of dollars. But it can be challenging for drug companies to prove to the Food and Drug Administration that generic versions of certain complex drugs are the same as their brand-name counterparts. To help, the agency issues guidance documents providing recommendations on how to demonstrate equivalence. However, we found that FDA...
GAO-18-61: Published: Nov 15, 2017. Publicly Released: Nov 15, 2017.
Some sunscreen active ingredients are not used in products marketed in the United States, although they have been available in other countries for more than a decade. Companies that manufacture some of these sunscreen ingredients have sought to bring them to the U.S. market by submitting applications to FDA between 2002 and 2009. We looked at the status of the applications and found that, as of A...
GAO-17-564: Published: Jul 11, 2017. Publicly Released: Jul 11, 2017.
FDA's expanded access program allows patients with serious or life threatening illnesses access to certain drugs before it has approved them. FDA also requires that manufacturers submit data about adverse reactions to these drugs. While FDA has provided some guidance to manufacturers, FDA does not fully explain the few instances when it would use these data on adverse reactions. This may influenc...
GAO-17-452: Published: May 25, 2017. Publicly Released: Jun 26, 2017.
Nearly 90% of the prescription drugs dispensed in the United States are generics. The Food and Drug Administration must approve these drugs before they are marketed. In 2012, a law allowed FDA to collect fees from drug manufacturers to support the review process. FDA committed to improving its process and meeting specific performance goals such as decreasing review times. We found that FDA's rel...
GAO-17-189: Published: Jan 31, 2017. Publicly Released: Mar 2, 2017.
Each year, over 2 million Americans get sick from bacterial infections that are resistant to antibiotics, and at least 23,000 die as a result. There has also been a steady decline in the development of new antibiotics since the 1980s—raising concerns that there may not be enough new antibiotics to replace those that have become ineffective. In response, the FDA has encouraged drug companies to...
GAO-17-143: Published: Dec 16, 2016. Publicly Released: Jan 17, 2017.
Much of the U.S. drug supply is manufactured overseas. FDA inspects drug manufacturing facilities around the world to ensure that their drugs are safe for the U.S. market. FDA uses a risk-based approach to select which manufacturing establishments to inspect—prioritizing those that make drugs which, if defective, pose the greatest public health risk. In part to help its inspection efforts, FDA...
GAO-14-194: Published: Feb 10, 2014. Publicly Released: Feb 10, 2014.
The number of drug shortages remains high. Although reports of new drug shortages declined in 2012, the total number of shortages active during a given year—including both new shortages reported and ongoing shortages that began in a prior year—has increased since 2007. Many shortages are of generic sterile injectable drugs. Provider association representatives reported that drug shortages may...