Assistant Secretary for East Asian and Pacific Affairs David R. Stilwell on the Secretary’s Travel to Japan, Mongolia, and the Republic of Korea

David R. Stilwell, Assistant SecretaryBureau of East Asian and Pacific Affairs

Via Teleconference

MS ORTAGUS:  Thank you very much.  Good morning, everyone in the U.S.  Good evening, everyone who is in Asia.  Thank you for joining us for this on-the-record conference call to discuss Secretary Pompeo’s upcoming visit to Japan, Mongolia, and the Republic of Korea.

We’d just like to address right off the top the Secretary is in Croatia today on his – he’ll be back to the U.S. very soon.  He did gaggle on the plane with our traveling press regarding this trip and if he was still going and other trips.  So the Secretary has addressed all of that.  The transcript has been out on our State Department website I think for a few hours now.  So we’re going to continue to proceed with this call, but I would refer you – any questions that you have that are related to COVID or traveling or anything of that nature, if you could please take a look at his gaggle this morning with the traveling press.  I think you can get all of your questions answered there.

So just moving on, the Secretary is intended to travel to Tokyo, Ulaanbaatar, and Seoul October 4th through the 8th for meetings with his foreign ministry counterparts and other senior officials.  While in Tokyo, he will participate in a second gathering of the Quad foreign ministers from Australia, India, and Japan.  This visit reflects the strong partnership between the United States and our partners and allies in the region and demonstrates our commitment to continuing the good work that is being done on the full range of bilateral, regional, and global issues that affect prosperity and security in the Indo-Pacific region.

The State Department official joining us today is my friend David Stilwell, assistant secretary for the Bureau of East Asian and Pacific Affairs.  While this call is on the record, please note that it is embargoed until the completion of this teleconference.  You can also get into the question queue at any point by dialing 1 and then 0.  As always, we ask you to try to limit it to one question if you can because we would like to take as many questions from as many reporters as possible.

I’ll now turn it over to Assistant Secretary Stilwell for his opening remarks.

ASSISTANT SECRETARY STILWELL:  Thank you, Morgan, and thank you all for joining us this morning.  We’ll run down through the desired objectives and the itinerary here for the trip.

So the Secretary will meet with his counterparts in the region on the 6th, 7th, and 8th of October.  As Morgan said, first stop is in Tokyo.  The timing is great considering Prime Minister Suga taking the helm in Tokyo now, and gives us the chance to reaffirm the bilateral relationship based on shared values and common regional and global vision.  The U.S.-Japan relationship, as we’ve said before, is the cornerstone of peace, security, and prosperity for the Indo-Pacific.  The seven-decade alliance is built on the common foundation of commitment to democracy, human rights, economic development, security, and people-to-people ties.

We thank former Prime Minister Abe for his vision in evolving our alliance, deepening investment in trade, strengthening security cooperation, and advocating for a free and open Indo-Pacific.  We see Prime Minister Suga’s decision to host this – his first visitor from the United States as an affirmation of our ever-strengthening partnership.

So our shared values lead us to stand shoulder to shoulder in dealing with regional and global challenges.  We are committed to the complete denuclearization of the DPRK, the end of the DPRK’s illicit ballistic missile programs, and the resolution of the abductions issue.  Together with our Quad partners, the United States and Japan stand up against PRC efforts to bully its neighbors, and we’re united by shared responsibility to uphold the benefits of democracy, human rights, economic development, and security and people-to-people ties.  So once we’re complete with – so we’ve got bilateral activity in Tokyo, obviously.  But we’d also like to thank Foreign Minister Motegi for hosting the second Quad Ministerial on the 6th of October.

Just a quick summary here.  The Quad is an informal grouping of likeminded partners formed to deepen cooperation on sub-regional issues and shape a more closely-aligned Indo-Pacific region.  As with our other sub-regional groupings including the U.S.-ROK-Japan trilateral group, the Quad members are heavily focused on concrete collaboration on shared challenges.  The core of the Quad partnership rests on a commitment to continued dialogue and work toward mutually agreed-upon outcomes.  Quad membership is driven by shared interests, not binding obligations.

The Quad was not formed to exclude nations.  It was a group formed in 2004 as part of the effort to coordinate our respective humanitarian assistance and disaster relief responses to the Indian Ocean tsunami.  And it was revived, the Quad was, in 2017.  Quad collaboration has grown beyond humanitarian assistance and disaster relief and now focuses on furthering our shared vision of a free, open, and inclusive Indo-Pacific region.  This last year has seen some of the Quad’s most remarkable growth, to include a focus on ASEAN centrality in our respective approaches to the region.

The Quad seeks to establish, promote, and secure Indo-Pacific principles, especially as PRC tactics, aggression, and coercion increase in the region.  Recent discussions among the Quad have focused on building cooperation with, in, and among members on issues including maritime security, cyber and critical technology, infrastructure, counterterrorism, and the Mekong regional cooperation.

So from there we will travel to Ulaanbaatar, as Megan noted – as Morgan noted, sorry – in Mongolia.  This is a – this is my first trip, and I think it’s the Secretary’s first trip as well.  We’re proud to establish and foster the relationship as strategic partners.  The U.S. is also the third neighbor and committed to supporting Mongolia’s efforts to strengthen Democratic institutions, enhance sovereignty, and diversify their economy.  This visit is an example of the importance the United States attaches to the U.S.-Mongolian relationship.

We have shared values with Mongolia.  The citizens of our two countries share a strong commitment to democracy, including respect for and protection of human rights and fundamental freedoms, including the freedom of religion.  Mongolia’s democracy is a model for the region.

Economically and in trade, U.S.-Mongolian trade and investment ties are strong and growing stronger.  One example is the $350 million Millennium Challenge Corporation second compact, which will increase the supply of fresh water to Ulaanbaatar by 80 percent.  Also, Mongolian cashmere is of the highest quality, and through USAID, we are actively supporting Mongolia’s efforts to scale up value-added processing of cashmere in Mongolia.

And finally, people-to-people ties.  The U.S. has great respect for traditional Mongolian culture.  Just last month we announced a major financial support of $200,000 through the Ambassador’s Fund for Cultural Preservation to preserve the Choijin Lama Temple Museum in Ulaanbaatar.  Over the years we’ve invested $2.5 million to help preserve Mongolia’s cultural heritage.

And then finally, we will finish up the trip in Seoul, South Korea.  So in Korea, we’ll reaffirm the ironclad U.S.-ROK alliance, which is a linchpin of peace and security in the region.  ROK is a critical partner on regional and global issues, including combatting COVID-19, advancing peace and prosperity on the Korean Peninsula, and strengthening regional ties under the Indo-Pacific strategy, along with ROK’s new southern policy.  Our relationship is grounded in our shared values.

On the corona, we value our close cooperation with the ROK on COVID-19.  The ROK has shown how a democracy can successfully combat the pandemic with openness and transparency.

On economic and people-to-people ties, the U.S. is the ROK’s second largest trading partner and top foreign investor after Japan.  The ROK is a major investor in the United States.  Our countries share a commitment to free trade, human rights, and democracy.  Our two peoples are bonded by a shared history of friendship and sacrifice.  And we continue to advance our cooperation on regional and global issues under the U.S. Indo-Pacific strategy and, as I said, the ROK new southern policy, and we welcome the ROK’s growing foreign assistance contributions and encourage them to continue in that regard.

So at all three stops the Secretary will meet with leaders as well as his counterparts, and this trip demonstrates strong U.S. commitment to our allies and partners as well as the region.  And with that, I look forward to your questions.

MS ORTAGUS:  Great.  Thank you.  Let’s start with Danh Lee from Zing News.

QUESTION:  Thank you.  Mr. Stilwell, I’m, again, from Zing News.  I’m calling from Vietnam.  My question is, U.S. in late August announced sanctions on Chinese entities involved in maritime actions in claim in the South China Sea.  Is – will there be talks on these maritime issues and international cooperation enforcing these sanctions?  Thank you.

ASSISTANT SECRETARY STILWELL:  I appreciate that question.  Yeah, as you note, there are Chinese companies that are state-owned enterprises that are conducting activities, as you mentioned, in the South China Sea, destroying a bunch of natural habitat, coral reefs, and all those things.  And that activity extends to a number of areas to include developing ports and others.

And so, yes, these are all topics that can and will probably be raised during this, but as far – the – there’s much to talk about in Quad cooperation.  As I mentioned that the ASEAN centrality and supporting ASEAN is an area where all four countries share a common interest, and therefore, as you mentioned topics such – like this will likely come up.  Thank you.

MS ORTAGUS:   Thank you.  Nick Schifrin, PBS.

QUESTION:  Dave, thanks for doing this.  Just very quick COVID question.  I know the Secretary has said that he was thinking about whether to go on the trip.  He’s now just said that he is going to go on the trip.  Whether there’s any changes to the trip because of the President’s diagnosis.

And my main question is about Taiwan.  Is the Secretary considering going to Taiwan given some of the PLA Chinese moves over the strait that have been more aggressive militarily recently?  Thanks.

MS ORTAGUS:  I’ll just take the first question and refer you to the Secretary’s transcript from his gaggle this morning.  And Dave, I’ll let you answer the Taiwan question.

ASSISTANT SECRETARY STILWELL:   Hey, Nick, again good hearing your voice and all that.  No, no further travel to announce at this point.

MS ORTAGUS:  Okay, great.  Soyoung Kim from RSA.

QUESTION:  Hi, good morning.  So I have a question regarding Secretary Pompeo’s visit to South Korea.  So can you share with us what Secretary Pompeo will discuss with South Korean counterparts regarding North Korea?  And as a side question, is Secretary Pompeo expecting any sort of October surprise between the U.S. and North Korea before the election?  Thank you.

ASSISTANT SECRETARY STILWELL:  Okay.  Thanks for that question.  In your interest, I think I covered the broad-brush topics during the stop in Korea.  You know, we have a very productive relationship with Korea and so there’s going to be lots to talk about.  And then we look forward to interactions with – at all levels of the Korean Government.  Thanks.

MS ORTAGUS:  Thank you.  And I’m sorry.  I forgot to remind everybody to dial 1 and 0 to get into the question queue.  Matt Lee, AP.

QUESTION:  Thank you.   Hey, Morgan, just logistically – a very – you’ve mentioned this gaggle.  You’re talking about the one from Rome to Dubrovnik?  Because that was where he said he was not sure.  And then as Nick said, he did say he was going to go ahead with the trip at the press conference in Dubrovnik.

So – but then there’s also – if I’m reading the pool report right, he’s going to do another gaggle on the way from Dubrovnik home.  So which gaggle are you talking about?  And should we all presume that since this briefing is going ahead that the trip is going ahead?  And then on substance, Assistant Secretary Stilwell, in Seoul on the – what’s the latest on the SMA?  Is there anything going on there?  Thank you.

MS ORTAGUS:  Thanks, Matt.  I would say all of the above, the gaggle, the press conference.  I think the press conference transcript is out.  If not, it will be soon so I don’t have anything beyond what the Secretary said.  Dave, go ahead.

ASSISTANT SECRETARY STILWELL:   Thanks, Morgan.  Yeah, on SMA, the discussions are ongoing and will continue.  And not a lot more to update on that.

MS ORTAGUS:  Great, thanks.  Nico Pandi from Jiji Press.

QUESTION:  Thank you.  Should we expect a joint statement after the Quad meeting?  And if so, do you anticipate it’ll concern Chinese activities in South China Sea and Hong Kong?

ASSISTANT SECRETARY STILWELL:  So I think you’ll see public availability related to.  As far as the joint statement, probably not.  And as I mentioned before, there are going to be a lot of areas for discussion.  And the ones you mentioned are out there and obvious.  But the great thing about this is it’s really productive and it can be freeform as well.  The first one last year in New York was very similar.

So again the bringing together of four distinct perspectives on issues has been very helpful.  This is the wonderful thing about the Quad is we have shared values but different perspectives, and from those come great ideas and elegant solutions.  Thanks.

MS ORTAGUS:  Thank you so much.  Humeyra Pamuk, Reuters?

QUESTION:  Hello, David.  Hello, Morgan.  I just wanted to ask, so it’s the Secretary’s first trip to Asia – East Asia in over a year and the first one since COVID began.  In the minds of Asian allies, obviously, the threat posed by China is always front and center not least due to proximity.  But now given the U.S. election is so close, meaning they don’t know if they’ll be dealing with the same administration in a couple of months’ time, how successful do you think you will be during this trip in terms of getting concrete pledges, concrete deliverables out of them?

And if I may, the President last week said at the United Nations that China was to blame for unleashing the coronavirus onto the world.  Then is China by extension responsible for infecting the President, would you say?  Thank you.

ASSISTANT SECRETARY STILWELL:  Hey, thanks for that question.  My experience in both regional travel, interaction with everybody in East Asia Pacific Bureau as well as dealing with Congress, we are all pretty much on the same sheet of paper with respect to the main issues in the region.

What we want to get back to what we had before the corona broke out is an economy that benefits the – everybody – the people.  We’ve seen a lot of corporation in the first three years before the global economy and movement was shut down related to corona, and we’re trying to get this whole thing jump started again.  But as far as changes and transitions, I – again, these issues are not controversial.  And I strongly believe they will continue. Thanks.

MS ORTAGUS:  Thanks, Humeyra.  Okay.  Will Mauldin, Wall Street Journal.

QUESTION:  Thank you so much.  I wanted to ask about the – I didn’t see this addressed in Secretary Pompeo’s comments – if you, Assistant Secretary Stilwell, were involved in any kind of notices to allies or even adversaries about the coronavirus diagnosis of the President and how they should treat that and what would change or what wouldn’t change on foreign policy?

And then on the – specifically on the trip, I was wondering what message you think this sends to Beijing that the U.S. is traveling to neighboring and nearby countries like Mongolia, South Korea, Japan?  And certainly, there have been issues with Mongolian minorities within China.  What do you think Beijing would take away from this, and what message would you want to send to them?  Thanks.

ASSISTANT SECRETARY STILWELL:  Yeah, the first question, I’ll just send – relay you to the White House.  Again, that’s not my bailiwick.  I’m not going to weigh into that.  As far as messages, this just – as I said in the opening, this just reaffirms a long-term commitment and the beauty of logistics if you’re in Northeast Asia taking advantage of the opportunity to see your likeminded allies, partners, friends in the region.

And so I’ve been dealing with Mongolia in this job, in my previous job as well in the Pentagon.  It’s been a positive relationship.  Third neighbor policy has been outstanding benefits for them and for us.  And as you know, Mongolia has been a strong contributor to peacekeeping operations and we encourage that.  We’ve talked a lot about other aspects of the relationship in my opening comments as well.  So it’s a trip to Northeast Asia, and this is a great chance to meet with and visit Mongolia.  Thanks.

MS ORTAGUS:  Okay.  The final person we have in the queue is Nike Ching, Voice of America.

QUESTION:  Thank you so much for the call.  Good morning, Morgan, and good morning, Dave.  I just wanted to follow up on Nick’s question on Taiwan.  Can we rule in or rule out during Secretary Pompeo’s trip to Asia a virtual meeting or other engagements with the Taiwanese leaders?  And how would any tele-meetings be consistent with the U.S. public law which is Taiwan Travel Act?  I’m asking this because there are rumor – there are speculations and just wanted to get clarification from both of you.  Thank you.

ASSISTANT SECRETARY STILWELL:  Well, I think the question on Taiwan is appropriate.  We have made statements of late to talk about things like the Six Assurances and the rest.  Again, Taiwan is a very capable ally and – or a capable partner in the region, especially in the areas of economics and culture.  But as I said before, we have no travel to announce.  And – but we – again, go back to our primary interest in ensuring and insisting that the issues with the mainland and with Taiwan are resolved peacefully and through dialogue.  And that’s what you’ve seen the administration steps are reinforcing that, that commitment made by both sides, as you know.  So, thanks.

MS ORTAGUS:  Thank you much, Nike.  Thank you to everybody for dialing in.  Have a good Friday.  And please e-mail us with any questions.  Thanks, Dave.

ASSISTANT SECRETARY STILWELL:  Thanks, Morgan.  See you.

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    The COVID-19 pandemic has necessitated major federal spending to respond to the national public health emergency and resulting economic turmoil. This response and the severe economic contraction from the pandemic have led to increased federal debt. Once the COVID-19 pandemic abates and the economy has substantially recovered, Congress and the administration will need to address the federal government’s fiscal challenges. To help change the long-term fiscal path, in September 2020 GAO recommended that Congress consider establishing a long-term fiscal plan that includes fiscal rules and targets, such as a debt-to-gross domestic product (GDP) target. In this report, GAO analyzed the changes in spending and revenue needed to reach six potential debt-to-GDP targets at the end of a 30-year period (2020-2049). To reach any of the targets, policymakers will need to cut program spending, increase revenue, or, most likely, a combination of both (see table). Illustrative Examples of Changes Needed to Achieve Debt-to-GDP Targets Debt target, percent of GDP (end of 30 years) Spending and revenue: total change over 30 years Program spending alone: Immediate and permanent decrease needed in annual projected program spendinga Revenue alone: Immediate and permanent increase needed in annual projected revenue Percent Dollars, trillions Percent Percent 140 25.4 13.8 18.5 120 31.2 16.9 22.8 100 37 20 27 80 42.8 23.1 31.2 60 48.5 26.3 35.4 0 (paying off all debt) 65.9 35.7 48.1 Source: GAO simulation. | GAO-21-211. Note: The simulation used for this analysis generally reflect historical trends, such as the extension of tax provisions scheduled to expire. It does not account for potential macroeconomic effects of fiscal policy changes over time. aProgram spending consists of all spending except interest payments on debt held by the public. When considering the spending and revenue changes needed to achieve various debt-to-GDP targets, policymakers may also consider how changes in assumptions about key variables—such as discretionary spending, revenue, and GDP—affect these fiscal outcomes. For example, if GDP growth is greater than expected, policymakers may have to make smaller spending cuts or revenue increases to reach a selected debt-to-GDP target than those that would be needed based on GAO’s standard assumptions. GAO created an interactive web tool accompanying this report to allow users to enter different assumptions for each of these variables. This tool illustrates how these changes would affect the different debt-to-GDP targets over time, as well as the changes in spending and revenue needed to achieve various targets. This tool can be found at https://www.gao.gov/products/GAO-21-211. Even before the fiscal and economic effects resulting from COVID-19, an imbalance between federal revenue and spending that is built into current law and policy was contributing to the growing federal debt. The Congressional Budget Office projects that by 2023 federal debt held by the public will reach 107 percent of GDP, its highest point in U.S. history. This situation—in which federal debt grows faster than GDP—means that our nation is on an unsustainable fiscal path. GAO was asked to review issues related to fiscal rules and targets and the federal fiscal condition. In response to this request, in September 2020, GAO issued a report (GAO-20-561) on key considerations for the design, implementation, and enforcement of fiscal rules and targets. This report supplements that work and describes how changes in assumptions of future spending and revenue affect the federal government’s projected fiscal condition. GAO updated its long-term simulations of federal revenue and spending to (1) analyze six potential debt-to-GDP targets and (2) measure the fiscal gap—the policy change needed to reach a given debt-to-GDP fiscal target from the start to the end of 30-years. GAO also analyzed how changes in key variables affected the debt-to-GDP targets and the fiscal gap. For more information, contact Jeff Arkin at (202) 512-6806 or arkinj@gao.gov.
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  • Justice Department Commends ASCAP and BMI’s Launch of SONGVIEW
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    On Dec. 21, 2020, The American Society of Composers (ASCAP) and Broadcast Music, Inc. (BMI), the two largest performance rights organizations (PROs) in the United States, announced the launch of SONGVIEW, a “comprehensive data platform that provides music users with an authoritative view of public performance copyright ownership and administration shares for the vast majority of music licensed in the United States.”[1]
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  • COVID-19: Federal Efforts Accelerate Vaccine and Therapeutic Development, but More Transparency Needed on Emergency Use Authorizations
    In U.S GAO News
    Through Operation Warp Speed—a partnership between the Department of Health and Human Services (HHS) and the Department of Defense (DOD)—the federal government is accelerating efforts to develop vaccines and therapeutics for COVID-19. A typical vaccine development process can take approximately 10 years or longer, but efforts under Operation Warp Speed seek to greatly accelerate this process by completing key steps simultaneously (see figure). As of October 15, 2020, Operation Warp Speed publicly announced financial support for the development or manufacturing of six COVID-19 vaccine candidates totaling more than $10 billion in obligations. It has also announced financial support for the development of therapeutics, such as a $450 million award to manufacture a monoclonal antibody treatment (a treatment that uses laboratory-made antibodies, which also may be able to serve as a prevention option). Operation Warp Speed Timeline for a Potential Vaccine Candidate Note: An Emergency Use Authorization allows for emergency use of medical products without FDA approval or licensure during a declared emergency, provided certain statutory criteria are met. The Food and Drug Administration (FDA) may temporarily allow the use of unlicensed or unapproved COVID-19 vaccines and therapeutics through emergency use authorizations (EUA), provided there is evidence that the products may be effective and that known and potential benefits outweigh known and potential risks. For vaccines, FDA issued guidance in October 2020 to provide vaccine sponsors with recommendations regarding the evidence FDA needed to support issuance of an EUA. For therapeutics, FDA has issued four EUAs as of November 9, 2020. The evidence to support FDA's COVID-19 therapeutic authorization decisions has not always been transparent, in part because FDA does not uniformly disclose its scientific review of safety and effectiveness data for EUAs, as it does for approvals for new drugs and biologics. Given the gravity of the pandemic, it is important that FDA identify ways to uniformly disclose this information to the public. By doing so, FDA could help improve the transparency of, and ensure public trust in, its EUA decisions. The U.S. had about 10.3 million cumulative reported cases of COVID-19 and about 224,000 reported deaths as of November 12, 2020. Given this catastrophic loss of life as well as the pandemic's effects on the U.S. economy, effective and safe vaccines and therapeutics are more important than ever. The CARES Act includes a provision for GAO to report on its ongoing monitoring and oversight efforts related to the COVID-19 pandemic. This report examines, (1) efforts of Operation Warp Speed to accelerate COVID-19 vaccine and therapeutic development; and (2) FDA's use of EUAs for COVID-19 therapeutics and vaccines, among other objectives. GAO reviewed federal laws and agency documents, including HHS and DOD information on vaccine and therapeutic development and EUAs as of November 2020. GAO interviewed or received written responses from HHS and DOD officials, and interviewed representatives from vaccine developers and manufacturers, as well as select public health stakeholders and provider groups covering a range of provider types. FDA should identify ways to uniformly disclose to the public the information from its scientific review of safety and effectiveness data when issuing EUAs for therapeutics and vaccines. HHS neither agreed nor disagreed with the recommendation, but said it shared GAO's goal of transparency and would explore approaches to achieve this goal. For more information, contact Mary Denigan-Macauley at (202) 512-7114 or deniganmacauleym@gao.gov, or Alyssa M. Hundrup at (202) 512-7114 or hundrupa@gao.gov.
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  • Opioid Use Disorder: Treatment with Injectable and Implantable Buprenorphine
    In U.S GAO News
    Of the medications used to treat opioid use disorder (OUD), only buprenorphine is both a controlled substance and available as an injection or implant. Buprenorphine is used to treat patients with OUD because it reduces or eliminates opioid withdrawal symptoms and blunts the euphoria or dangerous side effects of other opioids, such as heroin. When used to treat OUD, buprenorphine, in any form, is subject to additional laws and regulations that are overseen by the Drug Enforcement Administration (DEA), within the Department of Justice (DOJ) and the Substance Abuse and Mental Health Services Administration (SAMHSA), within the Department of Health and Human Services (HHS). To ensure patient safety when injectable and implantable buprenorphine is used, the Food and Drug Administration (FDA), within HHS has also required drug companies to establish risk evaluation and mitigation strategies to help ensure the benefits of these medications outweigh their risks. Providers and pharmacies must follow a number of specific steps based on federal requirements when providing treatment with injectable and implantable buprenorphine. Providers are responsible for prescribing, storing, and administering injectable and implantable buprenorphine, while pharmacies are responsible for dispensing these medications (see figure). Representatives GAO interviewed from provider groups and pharmacies said they did not find the steps involved in treating patients to be difficult overall. However, they stated that careful and timely coordination with each other and patients is needed at key steps of the process to ensure that the patient receives treatment. Representatives from provider groups and pharmacies reported that the risk of diversion of injectable and implantable buprenorphine is low. For example, all of the provider groups GAO spoke with said that diversion of injectable or implantable buprenorphine is unlikely, and representatives from three of the six provider groups said that the design of these formulations reduces opportunities for diversion due to how they are administered. Process for Treating Opioid Use Disorder with Injectable and Implantable Buprenorphine The use of injectable and implantable buprenorphine to treat OUD is relatively low compared to oral forms of buprenorphine. HHS has reported that about 7,250 prescriptions were issued for injectable and implantable buprenorphine in fiscal year 2019, compared to over 700,000 patients who received buprenorphine prescriptions for oral formulations to treat OUD or pain in that year. In 2018, SAMHSA estimated that about one-quarter of the estimated 2 million people with OUD had received some form of substance use treatment in the prior year. One form of treatment—medication-assisted treatment (MAT)— combines behavioral therapy with the use of certain medications. HHS has identified expanding access to treatment for OUD as an important strategy for reducing opioid morbidity and mortality, which includes increasing the number of injectable and implantable buprenorphine prescriptions. Congress included a provision in the SUPPORT Act for GAO to review access to and the potential for the diversion of controlled substances administered by injection or implantation. This report focuses on injectable and implantable controlled substances that can be used to treat OUD and specifically, describes the process for treating OUD with injectable and implantable buprenorphine and what is known about their use. GAO reviewed laws, regulations, and documentation from DEA, FDA, and SAMHSA governing the process of providing treatment with buprenorphine and interviewed officials from those agencies. GAO also interviewed representatives from stakeholder groups representing MAT providers; drug companies that manufacture injectable or implantable buprenorphine; and pharmacies that dispense these medications. HHS and DOJ reviewed a draft of this report, and GAO incorporated their technical comments, as appropriate. For more information, contact James Cosgrove at (202) 512-7114 or cosgrovej@gao.gov.
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  • Defense Real Property: DOD-Wide Strategy Needed to Address Control Issues and Improve Reliability of Records
    In U.S GAO News
    As required by the National Defense Authorization Act for Fiscal Year 2018, the Department of Defense (DOD) for fiscal year 2019 underwent a financial statement audit. In the military services' full financial statement audit reports for fiscal year 2019, the independent public accountants reported serious control issues related to events that occur during the life cycle of real property, consisting of adding, disposing, reconciling, valuing, and performing physical inventory counts. These control issues affect not only the reliability of financial statement reporting but also the quality of property record data that DOD officials need to make decisions for budget and mission planning, space management, and buying versus leasing options. Further, with DOD having almost half of the government's buildings, better data could help the federal government identify opportunities to dispose of unneeded buildings and reduce lease costs, thus potentially saving it millions of dollars. DOD has not yet developed a comprehensive, department-wide strategy—an element of leading practices for enterprise-wide real property management—to address the reported real property issues. Instead, each of the military services is independently developing corrective actions to address control issues, without applying common solutions among the services or department-wide. A department-wide strategy for remediating control issues would better position DOD to develop sustainable, routine processes that help ensure accurate real property records and, ultimately, auditable information for financial reporting for the department. Additionally, a DOD-wide strategy could help the military services more effectively and efficiently address reported control issues, particularly for those categorized as DOD-wide issues. The Acting Secretary, noting that the services had not accurately accounted for DOD's buildings and structures, required existence and completeness (E&C) verifications to be performed for all real property for fiscal year 2019. Given the lack of department-wide instructions for how to carry out the requirement, the military services independently developed approaches for performing the E&C verifications. Their approaches differed in both scope (what assets were verified) and methodology (how the assets were verified), including the extent to which instructions were written. Reporting and monitoring of the results by service and department-level management also differed. Without department-wide instructions for performing the fiscal year 2019 E&C verifications, the results were not comparable among the military services. Further, DOD and the military services did not obtain the complete and consistent information needed to create a DOD real property baseline or to help ensure that the department's real property records are reliable. DOD-wide instructions would help DOD obtain complete and comparable E&C verifications results, which would help DOD achieve an auditable real property baseline and, ultimately, its objective of an unmodified (“clean”) audit opinion. DOD manages one of the federal government's largest portfolios of real property. This engagement was initiated in connection with the statutory requirement for GAO to audit the U.S. government's consolidated financial statements. DOD's uncorrected deficiencies, including those affecting real property, prevent DOD from having auditable financial statements, one of the three major impediments preventing GAO from expressing an opinion on the accrual-based consolidated financial statements of the U.S. government. This report (1) identifies the real property control issues that independent public accountants reported that may affect the ability of the military services to establish and maintain accurate and complete real property records, (2) examines the extent to which DOD had a strategy to address the control issues, and (3) assesses the extent to which DOD provided guidance for the required E&C verifications during fiscal year 2019 and how each military service implemented the directive. GAO analyzed fiscal year 2019 audit findings, reviewed key DOD documents, and interviewed DOD and military service officials. GAO is recommending that DOD (1) develop and implement an enterprise-wide strategy to remediate real property control issues and (2) issue DOD-wide instructions for the E&C verifications. DOD concurred with GAO's recommendations. For more information, contact Kristen Kociolek at (202) 512-2989 or kociolekk@gao.gov.
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  • GAO Audits Involving DOD: Status of Efforts to Schedule and Hold Timely Entrance Conferences
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    GAO began 37 new audits that involved the Department of Defense (DOD) in the fourth quarter of fiscal year 2020. Of GAO's 37 requested entrance conferences for those audits, DOD scheduled 33 within 14 days and held 34 within 30 days of GAO's notification. Entrance conferences are initial meetings between agency officials and GAO staff that allow GAO to communicate its audit objectives and enable agencies to assign key personnel to support the audit work. The four entrance conferences that were scheduled more than 14 days after notification were scheduled late due to either difficulties in identifying a primary action officer or aligning the schedules of GAO and DOD officials. The three entrance conferences that were held more than 30 days after notification were scheduled late due to difficulties in aligning the schedules of GAO and DOD officials. GAO's agency protocols govern GAO's relationships with audited agencies. These protocols assist GAO in scheduling entrance conferences with key agency officials within 14 days of their receiving notice of a new audit. The ability of the Congress to conduct effective oversight of federal agencies is enhanced through the timely completion of GAO audits. In past years, DOD experienced difficulty meeting the protocol target for the timely facilitation of entrance conferences. In Senate Report 116-48 accompanying a bill for the National Defense Authorization Act for Fiscal Year 2020, the Senate Armed Services Committee included a provision for GAO to review DOD's scheduling and holding of entrance conferences. In this report, GAO evaluates the extent to which DOD scheduled entrance conferences within 14 days of receiving notice of a new audit, consistent with GAO's agency protocols, and held those conferences within 30 days. This is the final of four quarterly reports that GAO will produce on this topic for fiscal year 2020. In the first three quarterly reports, GAO found that DOD had improved its ability to meet the protocol target. GAO analyzed data on GAO audits involving DOD and initiated in the fourth quarter of fiscal year 2020 (July 1, 2020, through September 30, 2020). Specifically, GAO identified the number of notification letters requesting entrance conferences that it sent to DOD during that time period. GAO determined the number of days between when DOD received GAO's notification letter for each new audit and when DOD scheduled the entrance conference and assessed whether DOD scheduled entrance conferences within 14 days of notification, which is the time frame identified in GAO's agency protocols. GAO also determined the date that each requested entrance conference was held by collecting this information from the GAO team conducting each audit and assessed whether DOD held entrance conferences for new audits within 30 days of notification, which was the time frame identified in the mandate for this review. For more information, contact Elizabeth Field at (202) 512-2775 or Fielde1@gao.gov.
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