Prescription Opioids: Patient Options for Safe and Effective Disposal of Unused Opioids

In 2017, an estimated 11.1 million Americans misused a prescription pain reliever, which included opioids. This misuse contributes to opioid abuse and death, which has quintupled from 1999 to 2017; about 17,000 people died from prescription opioid overdoses in 2017. Government agencies and stakeholders have attempted to address the potential for misuse and abuse by facilitating safe disposal of unused prescription opioids and other drugs.

The SUPPORT for Patients and Communities Act enacted in 2018 included a provision for GAO to review patient disposal of unused opioids, among other things. This report examines (1) federally recommended and other available methods patients may use to dispose of unused prescription opioids, and (2) what is known about patients' use of these methods.

To do this work, GAO examined peer-reviewed, academic literature on outcomes for prescription opioid disposal; reviewed federal agency documentation; interviewed federal agency officials, independent researchers, and stakeholder group representatives—such as those from the American Medical Association; and analyzed DEA data as of April 2019 on permanent drug collection sites. GAO also interviewed representatives of three companies that manufacture commercial in-home disposal products and reviewed publicly available documents about these products.

The Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and Environmental Protection Agency (EPA) recommend that patients dispose of unused presciption opioids by bringing them to DEA-registered collection sites or a DEA take-back event, or using mail-back programs. As of April 2019, 70 percent of the U.S. population lived less than 5 miles from permanent collection sites, which are often located at pharmacies. If collection sites, take-back events, or mail-back programs are not feasible, FDA recommends quickly and permanently removing the most dangerous prescription opioids, such as hydrocodone and fentanyl, from the home by flushing them down the toilet. For all other prescription opioids, the agencies recommend disposal in the trash after mixing them with unpalatable substances, such as cat litter. Commercial products to facilitate in-home disposal also exist, and FDA is aware that patients may opt to use these products for disposal in the trash.

Available studies suggest that many patients are unaware of federally recommended disposal methods or choose not to dispose of unused prescription opioids. For example, five studies found that between one-quarter and three-quarters of patients stored unused opioids for future use or had misplaced their unused opioids. Further, federal data indicate that 85 percent of intentional misuse occurs with the patient's knowledge—for example, when a patient sells or gives away unused prescription opioids. To educate and motivate patients to dispose of unused opioids, FDA launched a public awareness campaign called “Remove the Risk” in April 2019. Also, FDA and other stakeholders have created educational materials for patients and providers on safe opioid disposal.

The Substance Abuse and Mental Health Services Administration  (SAMHSA) estimates that in 2017, 11.1 million people aged 12 or older  used a prescription pain reliever, which includes opioids, in a way not  intended by the prescriber. Health care providers prescribe opioids to  treat chronic pain and after an acute medical event, such as a surgery, to  help patients manage pain while they heal. Because patients may not  take all of the opioids that their providers prescribe, many possess excess  opioids that could be misused by the patient or someone else. This  misuse contributes to opioid abuse and can lead to overdoses.  Overdoses involving prescription opioids—hereafter referred to as  opioids—were five times higher in 2017 than in 1999, accounting for  about 17,000 deaths in 2017.

Federal, state and local government agencies, drug manufacturers,  communities, and others have attempted to address the potential for  misuse and abuse by identifying or providing safe, secure, and  convenient methods for disposing of unused, unneeded, or expired  opioids. However, there is no federal law or regulation imposing  requirements for how patients are to dispose of unused opioids.

The SUPPORT for Patients and Communities Act (SUPPORT Act)  included a provision for us to review options for patients to dispose of  unused opioids, including products intended to facilitate in-home  disposal. In this report we describe:  1.  The federally recommended and other available methods patients  may use to dispose of unused opioids, and  2.  What is known about patients’ use of these methods to dispose of  unused opioids and examples of efforts to educate patients and  providers about opioid disposal.

To describe the methods that federal agencies recommend patients use  to dispose of unused opioids, we reviewed documentation and  interviewed officials from the three federal agencies that have authorities  related to the disposal of opioids—the Drug Enforcement Administration  (DEA), the Food and Drug Administration (FDA), and the Environmental  Protection Agency (EPA). We analyzed data from DEA as of April 2019  indicating the locations of permanent drug take-back collection sites in  conjunction with data from the U.S. Census Bureau’s population  estimates through 2017. We used these data to estimate the percentage  of the U.S. population living within varying distances of a permanent  collection site. For all data used in these analyses, we reviewed related  documentation and conducted electronic testing and, based on these  steps, determined that the data were sufficiently reliable for our purposes.  To describe other disposal methods, we reviewed documents and studies  from vendors of three commercial in-home disposal products that patients  can use to help them dispose of prescription and nonprescription  medication in their home trash. We identified these products and  documents through stakeholder interviews, a related study, a patent  search using Google Patents, and a review of product websites.  Additionally, we conducted interviews with other stakeholders—including  researchers, a representative from the AmerisourceBergen Foundation,  and representatives from three companies that manufacture in-home drug  disposal products. We asked these stakeholders about the effectiveness  of these other disposal methods at preventing misuse of opioids.

To describe what is known about which methods patients use to dispose  of unused opioids, we conducted interviews with stakeholders, such as  the Association for Accessible Medicines and the American Medical  Association (AMA), and reviewed results of SAMHSA’s 2017 National  Survey on Drug Use and Health. We also conducted a literature review.  Specifically, we performed a structured search of research databases— such as Scopus, ProQuest, ProQuest Dialog, and Harvard Think Tank— to identify literature published from January 1, 2009 through February  2019. In our search, we used a combination of terms such as “controlled  substance,” “disposal,” “drug,” and “prescription.” These searches  retrieved 846 results, of which 191 studies were selected by a librarian  based on general relevancy for further review. We selected 25 studies  based on the following criteria: if the study was published after January 1,  2014 and (1) presented findings that assessed the effectiveness of  certain methods for disposing of opioids and other medications, (2)  documented the quantity of unused opioids in the community, (3)  examined how patients disposed of unused opioids, or (4) evaluated  patient attitudes toward opioid disposal. The findings from each  individual study are limited by the studies’ overall lack of national  representation and small patient populations; however, taken together,  we found that the methods and conclusions were sufficient for our  purposes. To describe examples of efforts to educate patients and  providers about opioid disposal, we interviewed officials from FDA and  the AMA and reviewed relevant documentation from each.

We conducted this performance audit from December 2018 to September  2019 in accordance with generally accepted government auditing  standards. Those standards require that we plan and perform the audit to  obtain sufficient, appropriate evidence to provide a reasonable basis for  our findings and conclusions based on our audit objectives. We believe  that the evidence obtained provides a reasonable basis for our findings  and conclusions based on our audit objectives.

Opioids, such as hydrocodone and oxycodone, can be prescribed to treat  both acute and chronic pain. Opioids can pose serious risks when they  are misused. These risks include addiction, overdose, and death. As a  result, opioids are classified as controlled substances, which means that  their use and disposal are subject to additional oversight by DEA.

Some studies suggest that the majority of patients who received  prescriptions for opioids often do not use a large portion of the drugs  dispensed. A study that surveyed U.S. adults who had received opioids  found that approximately 60 percent of patients who were no longer using  the medication had unused opioids. Two studies reported that over one- half of patients did not use all of the opioids prescribed to them after  surgery; these studies found that patients reported leaving 15 to 20 pills  unused, representing 54 percent to 72 percent of the opioids they were  prescribed. Another study on patient opioid use after a cesarean section  and thoracic surgery found that most patients, 83 percent and 71 percent  respectively, used less than half of the total opioids they were  prescribed.

There is no federal law or regulation imposing requirements for how  patients are to dispose of unused opioids. However, DEA, FDA, and EPA  all have authorities and initiatives related to patient disposal of opioids.

DEA regulations specify three take-back options that patients can opt to  use to dispose of their unused controlled substances: take-back events,  permanent collection sites, and mail-back programs. DEA hosts semi- annual events called National Prescription Drug Take-Back Days, where  temporary collection sites are set up in locations such as police stations.  Advertisements encourage community participation in the events and  educate the community on safe disposal of unused medications, including  opioids. DEA also registers collectors and provides information to the  public about the location of permanent collection sites for take-back, such  as at local retail pharmacies or hospital pharmacies, and sets  requirements for the provision of postage-paid envelopes that patients  can use to mail unused drugs to a collector for destruction.

DEA regulations establish a standard for the destruction of controlled  substances that applies to DEA registrants, which can destroy opioids on  patients’ behalf. DEA registrants include pharmaceutical companies that  manufacture controlled substances, health care providers who prescribe  them, and pharmacies that dispense them. The standard for destruction  requires that controlled substances maintained or collected by DEA  registrants be rendered non-retrievable. This means that the physical and  chemical conditions of the controlled substance must be permanently  altered, thereby rendering the controlled substance unavailable and  unusable for all practical purposes. According to DEA, as of May 2019,  the only method currently used to meet this standard is incineration, and  DEA rulemaking states that DEA will not evaluate, review, or approve  methods used to render a controlled substance non-retrievable.

FDA has broad authority under the Federal Food, Drug, and Cosmetic Act  to evaluate whether a drug is safe and effective and ensure the benefits  of drugs outweigh the risks. FDA may require manufacturers to develop a risk evaluation and mitigation strategy (REMS) for drugs with serious  safety risks, including the risk of abuse, to ensure that the benefits  outweigh the risks. Under one REMS, for example, manufacturers of  opioids intended for outpatient use must make training available to health  care providers involved in the treatment and monitoring of patients who  receive opioids. The training must contain certain elements, including how  providers should counsel patients and caregivers about the safe use and  disposal of these opioids, among other things.

In October 2018, the SUPPORT Act authorized FDA to, at its discretion,  require specific packaging or disposal systems as a part of certain drugs’  REMS. For drugs with a serious risk of overdose or abuse, FDA may  require the drug to be made available for dispensing to certain patients  with “safe disposal packaging” or a “safe disposal system” for purposes of  rendering the drug non-retrievable in accordance with DEA regulations.  Before imposing these requirements, FDA must consider the potential  burden on patient access to the drug and the health care delivery system.  As of May 2019, FDA had not imposed any REMS requirements using the  new SUPPORT Act authority.

Under the Resource Conservation and Recovery Act (RCRA), EPA has  authority to regulate the generation, transportation, treatment, storage,  and disposal of hazardous waste, including certain discarded opioids.  However, hazardous waste pharmaceuticals generated by households  are not regulated as hazardous waste even if the waste would otherwise  be considered hazardous. Opioids and other household waste  pharmaceuticals collected through a take-back option are also exempt  from most hazardous waste regulations, provided certain conditions are  met. Some states and localities have imposed additional requirements  for pharmaceutical disposal, such as requirements for drug manufacturers  to manage or fund the disposal of collected household pharmaceuticals.

Federal Agencies Recommend Take- Back Options as the Preferred Disposal Method

Federal Agencies Recommend Take-Back Options Whenever Feasible, Followed by Disposal Using the Toilet or Trash

According to DEA, FDA, and EPA, patients should use take-back options  to dispose of unused opioids, whenever feasible. Only if take-back  options are not feasible, FDA recommends flushing opioids on FDA’s  flush list down the toilet to remove them from the home as soon as  possible. For opioids not on the flush list, the agencies recommend  placing the drugs in the household trash mixed with an unpalatable  substance. (See fig. 1). Officials from FDA said that the primary goal of  these recommendations is to remove dangerous substances from the  home as soon as possible to reduce accidental poisoning, which also  may address issues related to intentional misuse. FDA officials explained  that the agency has not measured the effects of its recommendations for  disposing of opioids on opioid misuse, as of May 2019, because it is  difficult to establish a causal link between the recommendations and any  reductions in misuse.

DEA, FDA, and EPA recommend using a take-back option as the  preferred method for patients to dispose of unused prescription opioids.  Under this method, patients can bring unused opioids to DEA’s semi- annual take-back events or to DEA-registered permanent collection sites,  or use mail-back to deliver opioids to a DEA-registered collector for  destruction. When patients use these take-back options, the drugs they  dispose of are ultimately incinerated, which is the only method that DEA  officials said is known to render the drugs non-retrievable, that is,  permanently and irreversibly destroyed.

Our analysis of DEA and U.S. Census Bureau data shows that as of April  2019, 71 percent of the country’s population lived less than 5 miles from a  permanent collection site, and in 42 states, at least half of the population  lived within 5 miles of a site. (See fig. 2). This number has increased  since our April 2017 report, when we found that about half of the country’s  population lived less than 5 miles away from a site. Our analysis also  shows that 90 percent of the population lived within 15 miles of a site,  though in rural areas only 57 percent lived within 15 miles. In addition,  two studies found that patients were willing to bring unused opioids to a  take-back location as long as it was located within 5 to 8 miles of their  home address.

If take-back options are not feasible, FDA recommends flushing the  opioids on its flush list down the toilet, because a single dose can be fatal  to a child or a pet. Flushing is a permanent way to remove opioids from  the home. FDA confirmed that as of June 2019, 11 of 14 drugs on the  flush list are opioids, which represents about three-quarters of the  approved opioid active ingredients intended for outpatient use (see  sidebar). Some portion of drugs that are flushed down the toilet ultimately  enter surface and wastewater streams. However, a 2017 FDA study on  the environmental impact of drugs listed on the flush list concluded that  flushing these opioids has negligible effects on the environment and  human health, particularly relative to the amount of opioids that are  excreted after taking them as prescribed, because not all of the drug is  metabolized. (See text box for a summary of the effects of disposal  options on the environment.)

Environmental Effects of Disposal Options  The environmental impact of opioid disposal depends on the method used—take-back  options, flushing, or trash. According to Environmental Protection Agency (EPA) and  Drug Enforcement Agency (DEA) officials, disposal of drugs through take-back options  results in disposal by permitted incineration, which fully destroys the active form of the  drugs. EPA officials told us that flushing or placing opioids in the trash can introduce  active opioids into wastewater streams, groundwater, and surface waters.   Incineration of Drugs from Take-Back Options. Opioids disposed of using take-back  options are destroyed by incineration, which, according to DEA officials, is the only  method currently used to meet its non-retrievable standard for destruction. EPA officials  told us that based on data from DEA, the amount of household pharmaceutical waste  gathered and incinerated during DEA’s semi-annual take-back events is small compared  to the total amount of waste one incinerator burns on an average day.  EPA officials  recommended take-back options as the preferred method of opioid disposal.  Flushing. Opioids enter the water supply when excreted by patients who take opioids as  prescribed and when patients intentionally flush unused opioids down the toilet. EPA  officials told us that most wastewater treatment facilities are not designed to eliminate  opioids from wastewater streams. Further, measureable concentrations of opioids have  been reported in surface and ground water sources around the world.  Trash. Disposal of unused opioids in the trash often introduces opioids into landfills.  Studies in scientific literature show that pharmaceutical ingredients have been observed  in the water that passes through landfills, called leachate. Similar to opioids that are  flushed, opioids in landfill leachate can end up in wastewater streams and other water  sources, according to EPA officials.

If an opioid is not on the FDA flush list and a take-back option is not  feasible, the agencies direct patients to take a series of steps to dispose  of their opioids in household trash by:  (1)  mixing the drugs in an unpalatable substance such as dirt, cat  litter, or used coffee grounds,  (2)  placing the mixture in a sealed container or plastic bag, and  (3)  throwing the container in the trash.

An EPA official said that mixing the drugs with an unpalatable substance  is meant to deter misusers from searching through the trash to retrieve  the drugs. Disposal of opioids in the trash—either with an unpalatable  substance or in-home disposal product—removes them from the home,  but this option may not be permanent and the drugs still may be available  for misuse. Drugs that are disposed in the trash ultimately are introduced  to landfills, where they can escape landfill containment and enter  wastewater streams or ground water sources.

FDA Has Not Evaluated Commercial Disposal Methods

FDA’s website notes the availability of commercial products for disposing  of unused opioids and other drugs in the home. FDA officials stated  that, as of May 2019, the agency had not evaluated the effectiveness of  these products or made any recommendations related to their use, but  they are aware that patients may opt to use these products. These  products, known as in-home disposal products, are proprietary  substances that patients can mix with their unused drugs, including  opioids, before disposing of them in the trash. In-home disposal product  vendors told us they sell or donate their products to pharmacies, local law  enforcement, and community groups, which then distribute them to  patients. A representative from a group that distributes these products,  the AmerisourceBergen Foundation, noted that in-home disposal  products may be a convenient option for patients for whom take-back  options are not feasible, and marketing materials from a product vendor  instruct patients to use their product if a take-back option is not available.  Vendors indicate that their products can prevent misuse of opioids by  rendering drugs non-retrievable at home and by motivating patients to  dispose of unused opioids. According to DEA officials, rendering opioids  non-retrievable by using an in-home disposal product is challenging,  because the drugs have a variety of chemical and physical properties and  potencies. Furthermore, according to DEA officials, a lethal dose of  fentanyl can be as low as 250 micrograms in adults—and lower in  children—underscoring the importance of effective disposal.

Some vendors have presented evaluations of their commercial products.  A recent comprehensive review of eight in-home disposal products raised  concerns about the credibility of vendors’ evaluations and concluded that  additional independent laboratory analysis is needed to fully examine  product performance and assess how well these products achieve stated  goals. Our review of evaluations from three vendors found that the  studies contained some inconsistencies and gaps in the evaluation  methods used, raising questions about the studies’ conclusions that the  products are effective for disposing of opioids.

In some cases, studies included detailed, but inconsistent, methods.  For example, in four studies about one product, the researchers  concluded that the product deactivated most of an opioid dissolved in  water. However, one of the earlier studies reported that whole pills did  not dissolve in water, which could impact the results, but later studies  did not include similar data.

In other cases, companies’ evaluations were summaries of results  that did not provide enough information to independently verify or  assess whether the products deactivate opioids and prevent misuse.  For example, one company’s research documents presented images  of a mixture as evidence that the drugs had degraded, rather than  results of a test measuring if drugs were still detectable.

In addition, the studies included little information about the products’  effectiveness at treating mixtures of multiple drugs at the same time, a  scenario that stakeholders have referred to as “real world” use testing.

Few Patients Use Federally Recommended Opioid Disposal Methods; FDA and Others Have Taken Steps to Educate the Public

Few Patients Use Federally Recommended Methods to Dispose of Unused Opioids

Disposal methods—when patients use them promptly—remove unused  opioids from the home and therefore can be effective at reducing opioid  misuse. FDA officials said that the federally recommended methods for  disposing unused opioids are intended to remove these substances from  the home as soon as possible, and stated that as long as individuals  dispose of opioids promptly rather than storing them, then FDA has  achieved its goal.

However, the studies we reviewed suggest that most patients do not  dispose of unused opioids using a federally recommended method.  Specifically, three studies examined how patients disposed of unused  opioids and found that between 12 percent and 41 percent of patients  disposed of them using a federally recommended method. For example,  one of the studies found that of 570 survey respondents who had unused  opioids, 12 percent of respondents reported using a take-back option, 14  percent reported that they flushed them down the toilet, and 6 percent  reported that they threw them in the trash after mixing with an unpalatable  substance.

Other studies we reviewed show that take-back options are often used to  dispose of drugs other than opioids. Two studies found that less than 10  percent of the catalogued drugs brought to DEA take-back days were  controlled substances, which included opioids, while another study  weighed drugs brought to take-back events and permanent collection  sites and reported less than 3 percent were controlled substances,  including opioids. The same study found that annually, controlled  substances disposed of at take-back events and permanent collection  sites accounted for about 0.3 percent of those dispensed in the area, and  concluded that take-back events may have a minimal impact on reducing  the availability of unused opioids for misuse.

Studies indicate that patients who receive an in-home disposal product  may be more likely to dispose of unused opioids, but they may also be  less likely to use federally recommended options like take-back or  flushing. Two studies in our review found that patients who receive an in- home disposal product have reported that they are more likely to dispose  of unused opioids than those who did not receive the product. Use of in- home disposal products—which may not be effective at permanently  destroying drugs—may deter patients from using federally recommended  options, like take-back, that have been proven effective. For example,  one of these studies found that only one of the 70 patients who received  an in-home disposal product used a take-back option for disposal, despite  the study taking place in a state where we estimated that 77 percent of  the population lived less than 5 miles from a permanent collection site.

Studies indicate that patients are often unaware of federally  recommended disposal options. Three of the 25 studies we reviewed  suggest that many patients were not aware of federally recommended  methods for disposing of opioids. For example, a study of cancer  patients who received opioid prescriptions reported that more than three- quarters of these patients were unaware of proper opioid disposal  methods. Another 2016 study of 1,032 patients found that nearly half of  the respondents did not recall receiving information on proper disposal  from pharmacists, medication packaging, or media outlets.

Studies also indicate that patients choose not to dispose of unused  opioids, and that they knowingly participate in the majority of opioid  misuse. Five of the studies we reviewed found that between one-quarter  and three-quarters of patients stored unused opioids for future use or had  misplaced their unused opioids. For example, one of these studies  found that 49 percent of survey respondents kept or planned to keep  unused opioids for future use, and 14 percent were likely to let a family  member use their opioid medications in the future. Federal data about the sources of misused opioids indicate that patients are complicit with  most misuse. SAMHSA estimates that 5 percent of people nationwide  who misused opioids in 2017 took these drugs from someone else  without asking. In contrast, SAMHSA estimates that 85 percent of opioid  misuse occurs with the patient’s knowledge or active participation, either  through the patient misusing his or her own prescription by taking the  drug for pain other than for which it was prescribed or by giving or selling  the prescribed opioids to another person. (See fig. 3).

FDA and Others Have Taken Steps to Educate Patients and Providers about Appropriate Opioid Disposal

To motivate patients to use federally recommended methods to dispose  of unused opioids, FDA and some physician organizations have created  educational materials on safe disposal methods. For example, FDA  launched a public awareness campaign called “Remove the Risk” on April  25, 2019—complete with educational materials such as public service  announcements, social media posts, fact sheets, and other web-based  content. AMA representatives reported that the AMA has provided  physicians with educational material on drug disposal and prescribing.  Specifically, AMA representatives told us that the association has  compiled a two-page document for physicians containing information  about drug disposal, links to DEA information on nearby permanent  collection sites and take-back events, and FDA guidance on safe disposal  of medications. This document included recommendations for physicians  to talk to patients about safe use of prescription opioids, remind patients  to store their medications in a safe place out of reach from children, and  have a conversation with patients about the most appropriate ways to  dispose of expired, unwanted, or unused opioids.

The AmerisourceBergen Foundation has also partnered with communities  to promote safe opioid disposal by providing education about take-back  options and commercial in-home disposal products to patients. A  representative from the Foundation explained that its Safe Disposal  Support Program provides non-profit organizations or municipalities with  commercial in-home disposal products, which then can be distributed free  of charge to other organizations, individuals, or households. It also  recommends that patients use take-back options when available. The  representative said that organizations are to demonstrate to patients how  these products work either through a brief in-person demonstration at an  event or through a video. According to the representative, these products  and demonstrations help people reflect on what is in their home and  needs to be disposed of, either using a product or a take-back option.

Despite such efforts, little is known about the extent to which  stakeholders’ efforts to educate the public are effective in increasing use  of federally recommended disposal methods. FDA officials said that they  are not aware of the extent to which providers are familiar with all  disposal methods or the extent to which providers discuss the importance  of proper disposal with patients. As part of FDA’s REMS requirements for  outpatient opioids, manufacturers must make training available to health  care providers involved in the treatment and monitoring of patients who  receive opioids, which includes information about the need to  communicate with patients about disposal of unused drugs. FDA officials  said that opioid manufacturers must assess the effectiveness of their  REMS, including an assessment of prescribers’, other health care  providers including pharmacists’, and patients’ understanding of the key  risk messages conveyed through the educational materials. FDA expects  to receive the next REMS assessment with the results of these analyses  in 2020. The AMA has not been able to measure the effects of its  recommendations, but provided anecdotal feedback from its members  that many physicians do not consistently speak to their patients about  disposal.

FDA officials and AMA representatives indicated that in addition to  educating patients on opioid disposal methods, focusing efforts on  reducing the amount of unused opioids would be an effective approach  for reducing misuse and abuse. For example, FDA officials said that  adding packaging configurations that contain smaller quantities of certain  opioids could help prescribers to more carefully consider the amount of  opioid pain medication they prescribe.  This in turn may reduce the  number of unused opioids available in the home that could be  inappropriately accessed by family members or visitors, and could  potentially reduce the risk for misuse and abuse. Representatives from  the AMA explained that it and other organizations are working to provide  opioid prescribing resources and guidance to help physicians effectively  manage patients’ pain, which representatives said will reduce the number  of unused opioids available for misuse. FDA officials and a researcher  also noted that dispensing opioids in packaging that makes it easy to  count the number of unused pills may help patients identify intentional  misuse.

The FDA and EPA provided technical comments on a draft of this report,  which we incorporated as appropriate; the DEA did not have comments.

We are sending copies of this report to the appropriate congressional  committees, the Secretary of Health and Human Services, the  Administrator of the DEA, the Administrator of the EPA, and other  interested parties. In addition, the report is available at no charge on the  GAO website at http://www.gao.gov.

If you or your staff members have any questions about this report, please  contact me at (202) 512-7114 or cosgrovej@gao.gov. Contact points for  our Offices of Congressional Relations and Public Affairs may be found  on the last page of this report. GAO staff who made key contributions to  this report are listed in appendix I.

Appendix I: GAO Contact and Staff Acknowledgments

James Cosgrove, (202) 512-7114 or cosgrovej@gao.gov.

In addition to the contact named above, individuals making key  contributions to this report include Leslie V. Gordon (Assistant Director),  A. Elizabeth Dobrenz (Analyst-in-Charge), Sam Amrhein, Jieun Chang,  Diana Chung, Kaitlin Farquharson, and Dennis Mayo. Also contributing  were Giselle Hicks, Cynthia Khan, and Ethiene Salgado-Rodriguez.

An estimated 11.1 million Americans misused a prescription pain reliever, including opioids, in 2017. One of the ways government agencies and others have attempted to address misuse is by facilitating safe disposal of these drugs.

Federal agencies recommend that patients bring unused prescription opioids to registered collection sites or take-back events, or return them via a mail-back program. If these aren’t feasible, the FDA recommends rapid disposal of certain dangerous opioids—such as fentanyl—down a toilet.

Studies show most people are unaware of recommended disposal methods or have not disposed of unused prescription opioids.


F-35 Aircraft Sustainment: DOD Faces Challenges in Sustaining a Growing Fleet

DOD's F-35 Lightning II fighter aircraft provides key aviation capabilities to support the U.S. National Defense Strategy. The F-35 is also DOD's most costly weapon system, with U.S. sustainment costs estimated at more than $1 trillion over its life cycle. As of October 2019, there were more than 435 U.S. and international F-35 aircraft in operation, with more than 3,300 aircraft expected to be fielded throughout the life of the program. While there is little doubt that the F-35 brings unique capabilities to the U.S. military, DOD faces significant challenges in sustaining a growing fleet.

This statement discusses F-35 sustainment challenges. It also summarizes GAO's open recommendations related to these challenges.

This statement is based on previously published work since 2014 related to F-35 acquisition, sustainment, affordability, ALIS, operations, and the global supply chain.

The Department of Defense (DOD) faces challenges in sustaining a growing F-35 fleet. This statement highlights three challenges DOD has encountered related to F-35 sustainment, based on prior GAO work (see figure).

As a result of these challenges, F-35 performance has not met warfighter requirements. While DOD works to address these issues, it must also grapple with affordability. DOD has determined that it will need to significantly reduce F-35 sustainment costs—by 43 percent per aircraft, per year in the case of the Air Force—in order for the military services to operate the F-35 as planned.

Continued attention to GAO's recommendations in these areas will be important as DOD takes actions to improve F-35 sustainment and aircraft performance for the warfighter.

GAO has 21 recommendations related to the challenges described in this statement that DOD has not fully implemented. DOD generally concurred with all 21 recommendations. Continued attention to these recommendations is needed by DOD to successfully operate and sustain the F-35 fleet over the long term within budgetary realities.

Thank you for the opportunity to be here today to discuss the Department  of Defense’s (DOD) sustainment of F-35 aircraft. As you know, the F-35  Lightning II provides key aviation capabilities to support the National  Defense Strategy. It is DOD’s most costly weapon system, with  sustainment costs for the United States alone estimated at more than $1  trillion. The F-35 is also DOD’s most ambitious weapon system, with three  military services and many foreign nations purchasing the F-35 for their  militaries. While production continues to ramp up, as of October 2019,  there were more than 435 U.S. and international F-35 aircraft in operation  at 19 sites, with more than 3,300 aircraft expected to be fielded through  the life cycle of the program.

We have published a series of reports examining both DOD’s acquisition  and its sustainment of the F-35. My statement today will focus on  sustainment. Sustainment involves the activities necessary to operate  aircraft after they are fielded—such as maintenance, supply chain  management, training, and engineering support. Sustainment costs  typically comprise about 70 percent of a weapon system’s life-cycle cost.  In particular, we have reported on significant challenges that DOD faces  in sustaining a growing F-35 fleet. As a result of these challenges, F-35  performance has not met warfighter requirements. Mission capability— that is, the percentage of total time when the aircraft can fly and perform  at least one mission—was 52 percent from May through November 2018,  as compared with a warfighter minimum requirement of 75 percent.  Further, although the United States is purchasing the F-35 for its  advanced capabilities, during that same time period, full mission  capability—or the percentage of time when the aircraft can perform all  tasked missions—was about 27 percent, as compared with a warfighter  minimum requirement of 60 percent.

Today I will highlight three F-35 sustainment challenges DOD has  encountered related to: (1) the supply chain; (2) the Autonomic Logistics  Information System (ALIS), which supports supply-chain management,  maintenance, and other processes; and (3) long-term planning. I will also  summarize our recommendations related to these issues that DOD has  not fully implemented.

This statement is based on our body of work issued from 2014 through  2019 addressing F-35 acquisition, sustainment, affordability, ALIS,  operations, and global supply chain. To perform our prior work, we  analyzed DOD plans, program guidance, and F-35 performance; and we  interviewed DOD, military service, and contractor officials at the  headquarters’ level and at many military installations that house F-35  aircraft. The reports listed on the Related Products Page provide more  details on the scope and methodologies we used to carry out our prior  work, including data reliability assessments.

We conducted the work on which this testimony is based in accordance  with generally accepted government auditing standards. Those standards  require that we plan and perform the audit to obtain sufficient, appropriate  evidence to provide a reasonable basis for our findings and conclusions  based on our audit objectives. We believe that the evidence obtained  provides a reasonable basis for our findings and conclusions based on  our audit objectives.

DOD Faces Substantial Supply Chain Challenges

First, DOD is facing substantial supply chain challenges that are hindering  the readiness of the F-35 fleet. Specifically, spare parts shortages  throughout the F-35 supply chain are contributing to F-35 aircraft being  unable to perform as many missions or to fly as often as the warfighter  requires.

The F-35’s unique supply chain is central to DOD’s strategy to sustain the  growing fleet. Rather than owning the spare parts for their aircraft, the Air  Force, Navy, and Marine Corps, along with international partners and  foreign military sales customers, share a common, global pool of parts.  This construct for the F-35 supply chain was intended to ease the  logistical burden and provide economies of scale for the military services  and international partners; however, the global pool does not have  enough spare parts. Specifically, from May through November 2018, F-35  aircraft across the fleet were unable to fly about 30 percent of the time  due to parts shortages, as compared with a program target of 10 percent.

Below is pictured an F-35B aircraft conducting training aboard a ship.

Our work found that several factors contribute to these parts shortages,  including F-35 parts that are breaking more often than expected, and  DOD’s limited capability to repair parts when they break. Specifically, as  of April 2019, the F-35 program was failing to meet four of its eight  reliability and maintainability targets—which determine the likelihood that  the aircraft will be in maintenance rather than available for operations— including metrics related to part removals and part failures. For instance,  we reported at that time that the special coating on the F-35 canopy that  enables the aircraft to maintain its stealth had failed more frequently than  expected, and the manufacturer was unable to produce enough canopies  to meet demands.

These reliability challenges are exacerbated by DOD’s limited capability  to repair broken parts at the military depots. The capabilities to repair  parts are currently 8 years behind schedule. DOD originally planned to  have repair capabilities at the depots ready by 2016, but as we reported  in April 2019, the depots will not have the capability to repair all parts at  expected demand rates until 2024. As a result, the average time taken to  repair an F-35 part was more than 6 months, or about 188 days, for  repairs completed between September and November 2018—more than  twice as long as planned. At that time, there was a backlog of about 4,300  spare parts awaiting repair at depots or manufacturers.

We have also reported on other challenges that DOD faces related to its  supply chain, including challenges in supporting deployed F-35 aircraft  around the world, in clarifying how scarce parts will be distributed, in  establishing a plan for a global supply chain network, and in maintaining  accountability for spare parts. Figure 2 depicts many of these and other  challenges that DOD faces related to the F-35 supply chain.

DOD has not fully implemented seven of our recommendations related to  its supply chain challenges:

Revise sustainment plans: In October 2017, we reported that DOD’s  reactive approach to planning for and funding the capabilities needed  to sustain the F-35 resulted in significant readiness challenges— including delays in the establishment of part repair capabilities at the  depots—and placed DOD at risk of being unable to leverage the  capabilities of the aircraft it had purchased. We recommended that  DOD revise its sustainment plans to ensure that they include the key  requirements and funding needed to fully implement the F-35  sustainment strategy.

Conduct a comprehensive review of the F-35 supply chain: While  DOD had ongoing efforts to increase the availability of spare parts, we  found in April 2019 that DOD would likely continue to face challenges  because the program was not planning for the quantity of parts  necessary in its spare parts projections to meet warfighter  requirements. Simply purchasing more F-35 parts may not be a viable  solution for DOD, given the affordability concerns the program faces.  These complex problems necessitate a comprehensive approach by  DOD, or it is at risk that the F-35 will not be able to conduct the full  range of intended missions. We recommended that DOD conduct a  comprehensive review of the F-35 supply chain to determine what  additional actions are needed to close the gap between warfighter  requirements for aircraft performance and the capabilities that the F- 35 supply chain can deliver, in light of the U.S. services’ affordability  constraints.

Develop a process to modify the afloat and deployment spare  parts packages: DOD purchases certain packages of F-35 parts  years in advance to support aircraft on deployments, including on  ships—called afloat and deployment spare parts packages. In April  2019, we reported that continued modifications to parts and aircraft  can make such packages out-of-date by the time F-35 units deploy,  and that the F-35 program did not have a process and funding in  place to change out mismatched parts. This could put the military  services at risk of not having the parts they need to support future  deployments. We recommended that DOD develop a process to  modify afloat and deployment spare parts packages, to include  reviewing the parts within the packages to ensure that they match  deploying aircraft and account for updated parts demand, and aligning  any necessary funding needed for the parts updates.

Mitigate risks related to operating and sustaining the F-35 in the  Pacific: In March 2018, we issued a classified report on DOD’s initial  transfer of F-35s to a Marine Corps base in Japan that, among other  things, described the warfighting capabilities the F-35 brought to the  Pacific and assessed operational challenges the Marine Corps faced.  In April 2018, we publicly reported on the recommendations from this  classified report, including our recommendation that the Marine Corps  assess the risks associated with key supply chain-related challenges  related to operating and sustaining the F-35 in the Pacific, and that it  determine how to address those risks.

Revise the business rules for prioritizing scarce F-35 parts: In  April 2019, we reported that there was uncertainty about how the  program will prioritize scarce F-35 parts among global participants.  While the F-35 program had developed a set of business rules, those  rules lacked clarity and detail. Absent comprehensive business rules,  the F-35 program could face challenges in transparently allocating  parts to support competing U.S. and international requirements. We  recommended that DOD revise the business rules for the prioritization  of scarce F-35 parts across all program participants so as to clearly  define the roles and responsibilities of all stakeholders, the process  for assigning force activity designations, and the way in which  deviations from the business rules will be conducted.

Complete a detailed plan for the establishment of the global  network for moving F-35 parts: In April 2019, we reported that  DOD’s networks to move F-35 parts around the world to the United  States and international participants were immature. Because the F- 35 program did not fully recognize the complexity of establishing a  global network for moving F-35 parts, this network is now several  years behind schedule and there is risk that it will not be fully capable  to support an expanding fleet. We recommended that DOD complete  a detailed plan for the establishment of the global network for moving  F-35 parts that outlines clear requirements and milestones to reach  full operational capability, and that includes mechanisms to identify  and mitigate risks to the F-35 global spares pool.

Clearly establish how DOD will maintain accountability for F-35  parts: In April 2019, we reported that in its rush to field aircraft and its  heavy reliance on the prime contractor, DOD had not consistently  followed DOD guidance for property accountability. Simply put, DOD  did not have records of all the F-35 spare parts it had purchased;  where those parts were located; and how much the military services  had paid for them. We recommended that DOD issue a policy  consistent with DOD guidance that clearly establishes how DOD will  maintain accountability for F-35 parts within the supply chain, and  identify the steps needed to implement the policy retrospectively and  prospectively.

DOD concurred with these recommendations and has made some  progress in addressing them, including issuing a revised life cycle  sustainment plan in January 2019. In addition, DOD has taken actions to  increase the availability of spare parts, such as efforts to improve the  reliability of parts and incentivize manufacturers to repair parts.

Autonomic Logistics Information System Remains Immature

Second, DOD continues to face challenges with the F-35’s Autonomic  Logistics Information System (ALIS). ALIS is a complex information  technology system supporting operations, mission planning, supply-chain  management, maintenance, and other processes. It is intended to provide  the necessary logistics tools to F-35 users as they operate and sustain  the aircraft. For supply chain management, for example, ALIS is  supposed to automate a range of supply functions—including updating  the status of parts, generating supply work orders, and communicating  critical data about parts.

However, we reported in April 2019 that these capabilities were immature,  resulting in numerous challenges and the need for maintainers and  supply personnel at military installations to perform time-consuming,  manual workarounds in order to manage and track parts. We reported  that one Air Force unit estimated that it spent the equivalent of more than  45,000 hours per year performing additional tasks and manual  workarounds because ALIS was not functioning as needed. In our prior  work we identified several challenges associated with ALIS, including the  following examples (see table 1).

We have made six recommendations since 2014 to help DOD address  ALIS-related challenges. DOD generally concurred with these  recommendations. It addressed two by developing a plan that prioritizes  ALIS risks and creating a training plan for ALIS. However, DOD has not  taken action on four of our recommendations. These are:

Establish a performance-measurement process: In September  2014, we reported that ALIS had experienced recurring problems,  including user issues and schedule delays, and was a risk that could  adversely affect DOD’s sustainment strategy. But we found that DOD  did not have a process to determine and address the most significant  performance issues with ALIS based on user requirements, which  could limit its ability to effectively and efficiently address performance  issues and identify root causes of those issues. We recommended  that DOD establish a performance-measurement process for ALIS  that includes, but is not limited to, performance metrics and targets  that (1) are based on intended behavior of the system in actual  operations and (2) tie system performance to user requirements.

Incorporate cost-estimating best practices: In April 2016, we  reported that DOD’s $16.7 billion life cycle cost estimate for ALIS was  not fully credible since DOD had not performed key analyses as part  of the cost-estimating process. We recommended that DOD conduct  uncertainty and sensitivity analyses consistent with cost-estimating  best practices.

Ensure that future cost estimates use historical data: In April  2016, we also reported that DOD’s ALIS cost estimate was not fully  accurate because DOD did not use historical cost data, including  actual cost data from ALIS and data from other comparable programs.  We recommended that DOD ensure that future estimates of ALIS  costs use historical data as available and reflect significant program  changes consistent with cost-estimating best practices.

Test the operation of the F-35 when disconnected from ALIS: In  March 2018, we issued a classified report on DOD’s initial transfer of  F-35s to a Marine Corps base in Japan that, among other things,  described the warfighting capabilities the F-35 brought to the Pacific  and assessed any operational challenges the Marine Corps faced.  In April 2018, we publicly reported on the recommendations from this  classified report, including our recommendation that the F-35 program  test operating the F-35 disconnected from ALIS for extended periods  of time in a variety of scenarios, to assess the risks related to  operating and sustaining the aircraft, and determine how to mitigate  any identified risks.

We are currently conducting a review of ALIS, assessing how DOD is  managing current and future issues related to the system. We plan to  complete this review in early 2020.

DOD Lacks Critical Information to Effectively Plan for Long-term F-35 Sustainment

Third, at the core, DOD’s current sustainment challenges have largely  resulted from insufficient planning. We have found that DOD lacks  information about the technical characteristics and costs of the F-35,  which will impair its ability to plan for the long-term sustainment of the F- 35 fleet.

The current F-35 sustainment strategy states that the primary contractor  will provide logistics support for the aircraft. In October 2017, we  reported that while DOD planned to enter into 5-year, fixed-price,  performance-based contracts with the prime contractor in the next few  years, DOD did not have full information on F-35 technical characteristics  or costs to enable it to effectively negotiate those contracts. Specifically,  certain technical aspects of the aircraft remained immature or uncertain,  including reliability measures that are lagging behind operational  requirements. As previously discussed, in April 2019 we reported that  the F-35 program was still not on track to meet its targets for four out of  eight reliability and maintainability metrics, and that the program had not  taken adequate steps to ensure that those targets would be met. DOD  officials told us that there would be inherent risk in signing a long-term,  performance-based contract before reliability and maintainability data  were more fully known, as those data would influence how much aircraft  performance should cost.

In addition, DOD did not have full visibility into the actual costs of some  key sustainment requirements that are considered cost-drivers within the  program, such as the actual costs of parts and repairs. Thus, DOD had  relied on projected parts reliability and pricing to formulate cost estimates.  Actual costs of sustainment requirements can change significantly from  initial projections. For instance, we reported that, between the program’s  2014 and its 2015 estimates, the costs of initial spare parts over the life  cycle increased by $447 million. The lack of cost information continues to  be a challenge for DOD, as we reported in April 2019. DOD officials  have stated that they need to know actual costs in order to improve both  their confidence in the estimates and their understanding of how cost is  related to performance.

Below is pictured an F-35A aircraft being refueled.

Further, DOD lacks the technical data from the prime contractor needed  to fully understand the technical characteristics of the F-35 aircraft and  enable potential competition of future sustainment contracts. Technical  data include the blueprints, drawings, photographs, plans, instructions,  and other documentation required to adequately produce, operate, and  sustain weapon systems. Technical data are critical for weapon systems  such as F-35 aircraft, as they provide DOD with the information  necessary to support the fleet. In April 2019, we found that challenges  related to readiness and costs were driving DOD to begin to develop an  option for DOD-led supply chain management as a potential alternative to  the performance-based contracts through which the prime contractor  would provide logistics support. The DOD-led option would require the  department to obtain significant amounts of technical data on F-35 parts  from the manufacturers of those parts; however, at that time DOD was  facing challenges in obtaining the needed data.

DOD has not fully implemented 10 of our recommendations related to  these issues:

Develop a long-term Intellectual Property strategy: In September  2014, we reported that DOD had not identified all of the technical data  it needs from the contractor, and at what cost, to enable competition  of future sustainment contracts, which put the program at risk of not  having the flexibility to make changes to its sustainment strategy. We  recommended that DOD develop a long-term Intellectual Property  strategy to include, but not be limited to, the identification of current  levels of technical data rights ownership by the federal government  and all critical technical data needs and their associated costs.

Assess whether the program reliability and maintainability  targets are still feasible: In April 2019, we reported that the F-35  program continued to fall short of meeting performance targets for half  of its reliability and maintainability metrics. Program officials said that  those targets need to be reevaluated to determine more realistic  performance targets, but they had not taken action to do so. We  recommended that DOD assess whether the program’s reliability and  maintainability targets are still feasible, and revise accordingly.

Identify specific and measurable reliability and maintainability  objectives: In April 2019, we reported that the F-35 program’s plan  for improving reliability and maintainability did not address the four  under-performing metrics. Specifically, the guidance the program has  used to implement this plan does not define specific, measurable  objectives for what the desired goals for F-35 reliability and  maintainability performance should be. As long as these metrics  continue to fall short, the military services may have to settle for  aircraft that are less reliable and more costly to maintain than  originally planned. We recommended that DOD identify specific and  measurable reliability and maintainability objectives in its guidance.

Link reliability and maintainability improvement projects to the  associated objectives: In April 2019, we reported that the F-35  program had not aligned its planned reliability and maintainability  improvement projects with reliability and maintainability goals, which  could put the program at risk of not meeting those goals. We  recommended that DOD identify and document in guidance which  reliability and maintainability improvement projects will achieve the  identified objectives.

Prioritize funding for reliability and maintainability improvement:  In April 2019, we reported that the F-35 program office had estimated  potential life-cycle cost savings of more than $9.2 billion from  implementing the reliability and maintainability improvement projects  in its plan, but had not prioritized or dedicated funding in its budget  necessary to carry out the projects. As a result, projects had been  prematurely suspended or delayed. We recommended that the F-35  program office prioritize funding for the reliability and maintainability  improvement plan.

Re-examine the metrics DOD will use to hold the contractor  accountable: In October 2017, we reported that DOD might not be  using the appropriate performance metrics under trial performance- based agreements to achieve desired outcomes or hold the contractor  accountable for performance. We recommended that DOD re- examine the metrics that it will use to hold the contractor accountable  under the fixed-price, performance-based contracts, to ensure that  such metrics are objectively measurable, are fully reflective of  processes over which the contractor has control, and drive desired  behaviors by all stakeholders.

Delay entering into multi-year, fixed-price, performance-based  contracts: In October 2017, we reported that DOD was moving  quickly toward negotiating longer-term performance-based contracts  without a sufficient understanding of the actual costs and technical  characteristics of the aircraft, which put DOD at risk of overpaying for  sustainment support that is not sufficient to meet warfighter  requirements. We recommended that, before DOD enters into multi- year, fixed-price, performance-based contracts, it ensure that it has  sufficient knowledge of the actual costs of sustainment and technical  characteristics of the aircraft at system maturity.

Obtain comprehensive cost information for F-35 spare parts: In  April 2019, we reported that DOD did not have comprehensive cost  information for individual F-35 spare parts, and that it faced  challenges in obtaining this information from the prime contractor.  This lack of cost information impedes DOD’s ability to develop a  complete understanding of the costs for the F-35 system and to  effectively negotiate with the prime contractor for sustainment support.  We recommended that DOD develop a methodical approach to  consistently obtain comprehensive cost information from the prime  contractor for F-35 spare parts within the supply chain.

Formalize a methodology for recording military service funds  spent on F-35 parts: In April 2019, we reported that the military  services could not track the funds that they had spent for the  purchase of F-35 spare parts to the actual parts on their financial  statements, thereby hindering DOD’s financial improvement and audit  readiness efforts. We recommended that DOD complete and  formalize a methodology for the U.S. services to use in recording on  their financial statements the funds spent on F-35 parts within the  global spares pool.

Clearly define the F-35 supply chain management strategy: In  April 2019, we reported that DOD was caught between two distinct  sustainment concepts—the program’s official contractor-provided  logistics support construct and DOD’s effort to develop options for  DOD-led supply chain management. Until DOD clearly defines its  strategy for managing the F-35 supply chain in the future, the F-35  program will lack the certainty and unity of effort necessary to  meaningfully improve supply chain performance and reduce costs.  We recommended that DOD clearly define the strategy by which it will  manage the F-35 supply chain in the future and update key strategy  documents accordingly, to include any additional actions and  investments necessary to support that strategy.

DOD concurred with all of these recommendations. Seven of the  preceding recommendations were made earlier this year, and we  recognize that it will take time for DOD to implement them. However,  DOD’s attention to each of these recommendations is important to  improving its long-term sustainment planning.

In summary, DOD’s costs to purchase the F-35 are expected to exceed  $406 billion, and the department expects to spend more than $1 trillion to  sustain its F-35 fleet. Thus, DOD must continue to grapple with  affordability as it takes actions to increase the readiness of the F-35 fleet  and improve its sustainment efforts to deliver an aircraft that the military  services and partner nations can successfully operate and maintain over  the long term within their budgetary realities. DOD’s continued attention to  our recommendations will be important as it balances these goals. We will  continue to monitor DOD’s efforts to implement our recommendations.

Chairmen Garamendi and Norcross, Ranking Members Lamborn and  Hartzler, and Members of the Subcommittees, this completes my  prepared statement. I would be pleased to respond to any questions that  you may have at this time.

If you or your staff have questions about this testimony, please contact  Diana Maurer, Director, Defense Capabilities and Management, at (202)  512-9627 or maurerd@gao.gov.

Contact points for our offices of Congressional Relations and Public  Affairs may be found on the last page of this statement. GAO staff who  made key contributions to this testimony are Alissa Czyz and Kasea  Hamar (Assistant Directors); Jon Ludwigson, Vincent Buquicchio, Tracy  Burney, Desiree Cunningham, Jeff Hubbard, Justin Jaynes, Amie Lesser,  Sean Manzano, Jillena Roberts, Michael Silver, Maria Staunton, Tristan  T. To, Cheryl Weissman, and Elisa Yoshiara.

F-35 Joint Strike Fighter: Action Needed to Improve Reliability and  Prepare for Modernization Efforts. GAO-19-341. Washington, D.C.: April  29, 2019.

F-35 Aircraft Sustainment: DOD Needs to Address Substantial Supply  Chain Challenges. GAO-19-321. Washington, D.C.: April 25, 2019.

F-35 Joint Strike Fighter: Development Is Nearly Complete, but  Deficiencies Found in Testing Need to Be Resolved. GAO-18-321.  Washington, D.C.: June 5, 2018.

Warfighter Support: DOD Needs to Share F-35 Operational Lessons  Across the Military Services. GAO-18-464R. Washington, D.C.: April 25,  2018.

Military Aircraft: F-35 Brings Increased Capabilities, but the Marine Corps  Needs to Assess Challenges Associated with Operating in the Pacific.  GAO-18-79C. Washington, D.C.: March 28, 2018.

F-35 Aircraft Sustainment: DOD Needs to Address Challenges Affecting  Readiness and Cost Transparency. GAO-18-75. Washington, D.C.:  October 26, 2017.

F-35 Joint Strike Fighter: DOD’s Proposed Follow-on Modernization  Acquisition Strategy Reflects an Incremental Approach Although Plans  Are Not Yet Finalized. GAO-17-690R. Washington, D.C.: August 8, 2017.

F-35 Joint Strike Fighter: DOD Needs to Complete Developmental  Testing Before Making Significant New Investments. GAO-17-351.  Washington, D.C.: April 24, 2017.

F-35 Joint Strike Fighter: Continued Oversight Needed as Program Plans  to Begin Development of New Capabilities. GAO-16-390. Washington,  D.C.: April 14, 2016.

F-35 Sustainment: DOD Needs a Plan to Address Risks Related to Its  Central Logistics System. GAO-16-439. Washington, D.C.: April 14, 2016.

F-35 Joint Strike Fighter: Preliminary Observations on Program Progress.  GAO-16-489T. Washington, D.C.: March 23, 2016.

F-35 Joint Strike Fighter: Assessment Needed to Address Affordability  Challenges. GAO-15-364. Washington, D.C.: April 14, 2015.

F-35 Sustainment: Need for Affordable Strategy, Greater Attention to  Risks, and Improved Cost Estimates. GAO-14-778. Washington, D.C.:  September 23, 2014.

F-35 Joint Strike Fighter: Slower Than Expected Progress in Software  Testing May Limit Initial Warfighting Capabilities. GAO-14-468T.  Washington, D.C.: March 26, 2014.

F-35 Joint Strike Fighter: Problems Completing Software Testing May  Hinder Delivery of Expected Warfighting Capabilities. GAO-14-322.  Washington, D.C.: March 24, 2014.

F-35 Joint Strike Fighter: Restructuring Has Improved the Program, but  Affordability Challenges and Other Risks Remain. GAO-13-690T.  Washington, D.C.: June 19, 2013.

F-35 Joint Strike Fighter: Program Has Improved in Some Areas, but  Affordability Challenges and Other Risks Remain. GAO-13-500T.  Washington, D.C.: April 17, 2013.

F-35 Joint Strike Fighter: Current Outlook Is Improved, but Long-Term  Affordability Is a Major Concern. GAO-13-309. Washington, D.C.: March  11, 2013.

Joint Strike Fighter: DOD Actions Needed to Further Enhance  Restructuring and Address Affordability Risks. GAO-12-437. Washington,  D.C.: June 14, 2012.

Joint Strike Fighter: Restructuring Added Resources and Reduced Risk,  but Concurrency Is Still a Major Concern. GAO-12-525T. Washington,  D.C.: March 20, 2012.

Joint Strike Fighter: Implications of Program Restructuring and Other  Recent Developments on Key Aspects of DOD’s Prior Alternate Engine  Analyses. GAO-11-903R. Washington, D.C.: September 14, 2011.

Joint Strike Fighter: Restructuring Places Program on Firmer Footing, but  Progress Is Still Lagging. GAO-11-677T. Washington, D.C.: May 19,  2011.

Joint Strike Fighter: Restructuring Places Program on Firmer Footing, but  Progress Still Lags. GAO-11-325. Washington, D.C.: April 7, 2011.

Joint Strike Fighter: Restructuring Should Improve Outcomes, but  Progress Is Still Lagging Overall. GAO-11-450T. Washington, D.C.:  March 15, 2011.

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The F-35 fighter plays a key role in U.S. defense strategy. As of October, the United States and international partners had fielded more than 435 of an expected 3,300 aircraft.

We testified that DOD faces challenges keeping the growing fleet ready to perform its mission, largely due to insufficient planning. Challenges include

Spare parts shortages: F-35s were unable to fly about 30% of the time due to a lack of spare parts from May-November 2018

Poor performance of the information technology system used to sustain the aircraft: It requires manual workarounds and has data inaccuracies

We have 21 open recommendations to address these issues.