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. The Food and Drug Administration (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.
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 are among the many challenges with which FDA must routinely contend. 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 the public health. While progress has been made, we have found that some challenges remain and new ones, such as drug shortages, have emerged.
In 2015, we found that FDA had made substantial progress in addressing some of the concerns we raised in this high-risk area. Specifically, we determined that FDA had significantly improved 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 narrowed the scope of our high-risk designation. FDA 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 both medical device areas. At that time we also found that FDA had action plans in place to help it respond to two remaining issues of high importance: the effect of globalization on FDA’s ability to monitor medical product manufacturing, and the availability of medically necessary drugs. In addition, we reported that the agency’s leadership was committed to and supportive of initiatives in these two remaining areas. However, the agency’s capacity to address these issues was unclear, and the effectiveness of its monitoring and lack of adequate progress was a concern. Therefore, FDA’s oversight of medical products remained as a high-risk area.
Since 2015, we have found FDA has made some progress addressing our remaining concerns about globalization and drug availability. For example, FDA has demonstrated progress in responding to globalization by increasing the number of inspections it conducts of foreign manufacturing establishments producing drugs for the U.S. market. It has also improved the accuracy and completeness of information in its catalog of drug manufacturing establishments subject to inspection (which we referred to as an “inventory” in previous reports). The availability of more reliable data should enhance FDA’s oversight and help FDA apply its risk-based model for selecting drug establishments for inspection. FDA also has the opportunity to better monitor drug shortages by fully utilizing a recently implemented tracking system.
Although these are positive steps, we continue to have concerns in both areas. The effectiveness of FDA’s foreign offices, which began opening in 2008, has not yet been meaningfully assessed. In addition, persistently high vacancy rates in these offices suggest that they may lack the capacity to robustly monitor the global arena as the agency originally envisioned. As of July 2016, 46 percent of FDA foreign offices positions were vacant. Moreover, we found that some of the challenges FDA faces in recruiting staff to work in these offices are the same as those we reported on in 2010 and 2015.
With regard to ensuring drug availability, the way FDA monitors its drug shortage information remains a concern. Although it implemented a new tracking system—the Shortage Tracker—in March 2016, this is the fourth approach to monitoring shortages that the agency has taken in 5 years. According to FDA, it routinely enters data into the system, but the agency has not yet developed standard reports to help it manage its efforts, nor has it made plans to use these data to analyze trends or identify patterns to help it predict future shortages. Similarly, we remain concerned about the reliability and availability of information that is necessary to monitor postmarket drug safety. For example, FDA has not yet fully implemented a recommendation we made in 2013 to ensure its databases collect reliable and timely data on inspections of certain establishments that compound drugs.
In our 2015 high-risk report, we acknowledged the agency’s development of an action plan to respond to drug shortages. However, the agency did not follow through on its agreement to implement a recommendation we made in 2014 to periodically analyze its drug shortage data, and its implementation of an earlier recommendation to develop an information system to systematically track data about drug shortages, including their causes, has been inconsistent. These inconsistencies may undermine FDA’s action plan and its effectiveness. In addition, in December 2015 and May 2016, we identified new concerns regarding the agency’s collection of reliable data regarding postmarket drug safety and shortcomings in its broader strategic planning efforts for drugs and other medical products. As a result, we no longer consider that FDA has met the criteria associated with having an effective action plan, and are therefore changing its rating in this area from met to partially met.
In recent years, Congress has taken actions that have facilitated FDA’s ability to address concerns we have identified, and make progress in this important high-risk area.
- In July 2013, we reported that FDA’s authority to oversee drug compounding was unclear. The Drug Quality and Security Act, enacted in November 2013, helped clarify FDA’s authority to oversee drug compounding nationally. In November 2016, we reported that since the law’s enactment, FDA has issued numerous guidance documents related to compounding and conducted more than 300 inspections of drug compounders. These inspections have resulted in actions such as FDA issuing warning letters, which are issued for violations of regulatory significance, and recalls voluntarily initiated by manufacturers of potentially contaminated drugs.
- The Food and Drug Administration Safety and Innovation Act (FDASIA), enacted in July 2012, directed FDA to take a risk-based approach to inspecting both foreign and domestic drug manufacturing establishments, consistent with our 2008 recommendation. FDA has now fully implemented this provision. The number of foreign inspections has consistently increased each year since fiscal year 2009. In fiscal year 2015, FDA conducted more foreign than domestic inspections. The agency has also enhanced its risk-based approach to prioritizing drug establishments for inspection.
FDA’s oversight of medical products has been on our High-Risk List since 2009 and has also been considered one of the top 10 management challenges identified by the Department of Health and Human Services Office of Inspector General for more than a decade. While concerns remain, FDA has made progress and, in 2015, we determined that FDA’s leadership was committed to addressing our concerns related to both globalization and drug availability. In 2015, we also determined FDA had developed meaningful action plans to address both globalization and drug availability challenges. However, FDA has not sustained this level of effort for drug availability activities in the intervening years, and we no longer consider the agency to meet the criteria for having an effective action plan.
In addition to redoubling its efforts to develop—and sustain—an effective action plan for both globalization and drug availability, FDA needs to demonstrate that it has the capacity to address multiple challenges we have identified, along with effective monitoring strategies. For example, it needs to fully execute its plan to inspect the many foreign drug establishments making drugs for the U.S. market, for which it has no inspectional history, over the next 3 years.
Furthermore, FDA should implement our prior recommendations to resolve new and previously identified concerns, including the following:
- FDA should 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 inspections, import alerts, and warning letters.
- FDA should establish goals to achieve the appropriate staffing level for its foreign offices.
- FDA should routinely use its new Shortage Tracker and conduct periodic analyses to systematically assess drug shortage information to proactively identify risk factors for potential drug shortages.
- FDA should develop comprehensive plans, including goals and time frames, to correct problems with its postmarket safety data and ensure that these data can be easily used for oversight.
- FDA should consistently collect reliable and timely information in FDA’s databases on inspections and enforcement actions associated with compounded drugs.
GAO-17-143: Published: Dec 16, 2016. Publicly Released: Jan 17, 2017.
The Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), has increased its foreign drug inspections and enhanced its ability to prioritize drug establishments for inspection. The number of foreign inspections has consistently increased each year since fiscal year 2009. Beginning in fiscal year 2015, FDA conducted more foreign than domestic inspect...
GAO-17-64: Published: Nov 17, 2016. Publicly Released: Nov 17, 2016.
GAO's survey of state pharmacy regulatory bodies found that drugs are compounded in a variety of health care settings, and some data are collected on the number of entities that compound drugs (drug compounders), but not the volume of compounded drugs. In addition to pharmacies, drug compounding settings include physicians' offices and outsourcing facilities—a new type of facility established by...
GAO-16-595: Published: Jul 7, 2016. Publicly Released: Jul 7, 2016.
When available supplies of prescription drugs are insufficient, patient care may be adversely affected. The number of new shortages has generally decreased since 2011, while the number of ongoing shortages remained high.Number of Drug Shortages from January 2010 through December 2015 To help address shortages, the Food and Drug Administration (FDA) prioritized the review of—more quickly reviewed...
GAO-16-432: Published: May 16, 2016. Publicly Released: Jun 15, 2016.
The Food and Drug Administration (FDA) lacks measurable goals to assess its progress in advancing regulatory science—the science supporting its effort to assess the products it regulates. The agency issued strategic planning documents in 2011 and 2013 to guide its regulatory science efforts and identify priority areas for conducting work, but these documents do not specify the targets and time f...
GAO-16-500: Published: May 16, 2016. Publicly Released: Jun 15, 2016.
The Food and Drug Administration (FDA) developed a strategic integrated management plan (SIMP) for its three centers that oversee medical products (biologics, drugs, and medical devices); however, GAO found that the plan does not incorporate leading practices for strategic planning or document a comprehensive strategy for the centers. FDA officials explained that circumstances at the time of the S...
GAO-16-192: Published: Dec 15, 2015. Publicly Released: Jan 14, 2016.
From October 1, 2006, to December 31, 2014, the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) received about 1,000 requests for fast track designation and breakthrough therapy designation—two of the agency's four expedited programs to facilitate and expedite the development and review of new drugs. Drug sponsors are required to submit formal requests to use...
GAO-15-202: Published: Feb 2, 2015. Publicly Released: Mar 4, 2015.
Shortages of prescription drugs containing controlled substances have increased sharply in recent years; of the 168 shortages reported from January 2001 through June 2013, nearly 70 percent began after 2007. Such shortages lasted for nearly a year, on average. Additionally, many shortages involved generic pain relievers and drugs where there was only one manufacturer.The Food and Drug Administrati...
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...
GAO-13-702: Published: Jul 31, 2013. Publicly Released: Jul 31, 2013.
The authority of the Food and Drug Administration (FDA), an agency within the Department of Health and Human Services (HHS), to oversee drug compounding is unclear. Two federal circuit court decisions have resulted in differing FDA authority in different parts of the country. According to FDA officials, these inconsistent decisions and the agency's limited inspection authority over pharmacies have...
GAO-12-116: Published: Nov 21, 2011. Publicly Released: Dec 15, 2011.
The number of drug shortages has grown substantially since 2006. In total, 1,190 shortages were reported from January 1, 2001, through June 20, 2011, according to UUDIS data. From 2006 through 2010, the number of drug shortages increased each year. A record number of shortages were reported in 2010, and 2011 is on pace to surpass 2010's record. Sixty-five percent of shortages involved drugs that w...