December 4, 2021

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Court Enjoins California Company from Manufacturing and Distributing Adulterated Sterile Animal Drugs

17 min read
<div>A federal court enjoined a California company from distributing adulterated sterile animal drugs in violation of the Federal Food, Drug and Cosmetic Act (FDCA), the Department of Justice announced.</div>
A federal court enjoined a California company from distributing adulterated sterile animal drugs in violation of the Federal Food, Drug and Cosmetic Act (FDCA), the Department of Justice announced.

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    Why This Matters Contact tracing can help reduce transmission rates for infectious diseases like COVID-19 by identifying and notifying people who may have been exposed. Contact tracing apps, notably those using proximity tracing, could expedite such efforts. However, there are challenges, including accuracy, adoption rates, and privacy concerns. The Technology What is it? Contact tracing is a process in which public health officials attempt to limit disease transmission by identifying infected individuals, notifying their "contacts"—all the people they may have transmitted the disease to—and asking infected individuals and their contacts to quarantine, if appropriate (see fig. 1). For a highly contagious respiratory disease such as COVID-19, a contact could be anyone who has been nearby. Proximity tracing applications (apps) can expedite contact tracing, using smartphones to rapidly identify and notify contacts. Figure 1. A simplified depiction of disease transmission. Through contact tracing, an infected individual’s contacts are notified and may be asked to quarantine. (In reality, some contacts may not become infected, and some of those infected may not show symptoms.) How does it work? In traditional contact tracing, public health officials begin by identifying an infected individual. They then interview the individual to identify recent contacts, ask the individual and their contacts to take containment measures, if appropriate (e.g., a 14-day quarantine for COVID-19), and coordinate any needed care and testing. Proximity tracing apps may accelerate the process by replacing the time-consuming interviews needed to identify contacts. Apps may also identify more contacts than interviews, which rely on interviewees' recall and on their being acquainted with their contacts. Public health authorities provide the apps, often using systems developed by companies or research groups. Users voluntarily download the app for their country or region and opt in to contact tracing. In the U.S., state or local public health authorities would likely implement proximity tracing apps. Proximity tracing apps detect contacts using Bluetooth, GPS, or a combination of both. Bluetooth-based apps rely on anonymous codes shared between smartphones during close encounters. These codes contain no information about location or user identity, helping safeguard privacy. The apps allow public health authorities to set a minimum time and distance threshold for someone to count as a contact. Contact tracing can be centralized or decentralized. With a centralized approach, contacts identified by the app are often saved to a government server, and an official notifies contacts of possible exposure. For a decentralized approach, contact data are typically stored on the user's device at first. When a user voluntarily reports infection, the user's codes are uploaded to a database that other app users' phones search. Users who have encountered the infected person then receive notifications through the app (see fig. 2). Figure 2. Bluetooth-based proximity tracing apps exchange information, notify contacts exposed to an infected person, and provide follow-up information. How mature is it? Traditional contact tracing is well established and has been an effective infectious disease response strategy for decades. Proximity tracing apps are relatively new and not as well established. Their contact identifications could become more accurate as developers improve app technology, for example by improving Bluetooth signal interpretation or using information from other phone sensors. Opportunities Reach more people. For accurate COVID-19 contact tracing using traditional methods, public health experts have estimated that the U.S. would require hundreds of thousands of trained contact tracers because of the large number of infections. Proximity tracing apps can expedite and automate identification and notification of the contacts, reducing this need. Faster response. Proximity tracing apps could slow the spread of disease more effectively because they can identify and notify contacts as soon as a user reports they are infected. More complete identification of contacts. Proximity tracing apps, unlike traditional contact tracing, do not require users to recall or be acquainted with people they have recently encountered. Challenges Technology. Technological limitations may lead to missed contacts or false identification of contacts. For example, GPS-based apps may not identify precise locations, and Bluetooth apps may ignore barriers preventing exposure, such as walls or protective equipment. In addition, apps may overlook exposure if two people were not in close enough proximity long enough for it to count as a contact. Adoption. Lower adoption rates make the apps less effective. In the U.S., some states may choose not to use proximity tracing apps. In addition, the public may hesitate to opt in because of concerns about privacy and uncertainty as to how the data may be used. Recent scams using fake contact tracing to steal information may also erode trust in the apps. Interoperability. Divergent app designs may lead to the inability to exchange data between apps, states, and countries, which could be a problem as travel restrictions are relaxed. Access. Proximity tracing apps require regular access to smartphones and knowledge about how to install and use apps. Some vulnerable populations, including seniors, are less likely to own smartphones and use apps, possibly affecting adoption. Policy Context and Questions Although proximity tracing apps are relatively new, they have the potential to help slow disease transmission. But policymakers will need to consider how great the benefits are likely to be, given the challenges. If policymakers decide to use proximity tracing apps, they will need to integrate them into the larger public health response and consider the following questions, among others: What steps can policymakers take to build public trust and encourage communities to support and use proximity tracing apps, and mitigate lack of adoption by some populations? What legal, procedural, privacy, security, and technical safeguards could protect data collected through proximity tracing apps? What can policymakers do to improve coordination of contact tracing efforts across local, state, and international jurisdictions? What can policymakers do to expedite testing and communication of test results to maximize the benefits of proximity tracing apps? What can policymakers do to ensure that contact identification is accurate and that its criteria are based on scientific evidence? For more information, contact Karen Howard at (202) 512-6888 or HowardK@gao.gov.
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    What GAO Found GAO's analysis of 2020 data found that, for 20 selected brand-name prescription drugs, estimated U.S. prices paid at the retail level by consumers and other payers (such as insurers) were more than two to four times higher than prices in three selected comparison countries. The U.S. prices GAO estimated for comparison reflect confidential rebates and other price concessions, which GAO refers to as net prices. Publicly available prices for the comparison countries were gross prices that did not reflect potential discounts. As a result, the actual differences between U.S. prices and those of the other countries were likely larger than GAO estimates. The price differences varied by drug. Specifically, while estimated U.S. net prices were mostly higher than the gross prices in other countries (by as much as 10 times), some were lower. The following figure illustrates comparisons for two of GAO's selected drugs. GAO found similar differences in estimated prices paid by final payers at the manufacturer level. Estimated U.S. Net Prices and Selected Comparison Countries' Gross Prices at the Retail Level for Two Selected Drugs and Package Sizes, 2020 GAO's analysis found consumers' out-of-pocket costs for prescription drugs varied across and within all four countries but likely more within the U.S. and Canada where multiple payers had a role setting prices and designing cost-sharing for consumers, and not all consumers had prescription drug coverage. In Australia and France, prescription drug pricing was nationally regulated and prescription drug coverage was universal; thus, consumers' out-of-pocket costs within these countries for each drug were generally less varied. For example, in Australia, consumers typically paid one of two amounts for prescription drugs—either about 5 or 28 U.S. dollars in 2020. In the U.S., potential out-of-pocket costs for consumers could have varied much more widely depending on the type of coverage they had. For example, for one drug in GAO's analysis, considering only a few coverage options, consumers' out-of-pocket costs in 2020 could have ranged from a low of about 22 to a high of 514 U.S. dollars. GAO provided a draft to the Department of Health and Human Services for review and incorporated the Department's technical comments as appropriate. Why GAO Did This Study While spending on prescription drugs continues to grow worldwide, studies indicate the U.S. spends more than other countries. However, various factors—such as country-specific pricing strategies, confidential rebates to payers, and other price concessions—may obscure the actual prices of prescription drugs. GAO was asked to review U.S. and international prescription drug prices. This report (1) examines how prices at the retail and manufacturer levels in the U.S. compare to prices in three selected comparison countries—Australia, Canada, and France, and (2) provides information on consumers' out-of-pocket costs for prescription drugs in these countries. GAO analyzed 2020 price data for a non-generalizable sample of 41 brand-name drugs among those with the highest expenditures and use in the U.S. Medicare Part D program in 2017. Twenty of these drugs had price data available in all four countries. For U.S. prices, GAO estimated the net prices paid using data from various sources, including estimates of Medicare Part D rebates and other price concessions, and commercially available data. Prices for the selected comparison countries were obtained from publicly available government sources. National prices were not available for Canada, so GAO used the prices from Ontario, Canada's most populous province, as a proxy for Canadian prices. GAO also reviewed country-specific guidance and other relevant information and interviewed researchers, manufacturers, and government officials. For more information, contact John E. Dicken at (202) 512-7114 or dickenj@gao.gov.
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  • Combating Terrorism: U.S. Efforts to Address the Terrorist Threat in Pakistan’s Federally Administered Tribal Areas Require a Comprehensive Plan and Continued Oversight
    In U.S GAO News
    Since 2002, destroying the terrorist threat and closing safe havens have been key national security goals. The United States has provided Pakistan, a key ally in the war on terror, more than $10 billion in funds and assistance. Pakistan's Federally Administered Tribal Areas' (FATA) rugged terrain, poor economic conditions, low literacy, underdeveloped infrastructure, and unique legal structure, all add to the complexity of efforts to address the terrorist threat in the FATA. This testimony discusses the (1) progress of U.S. national security goals in the FATA, (2) status of U.S. efforts to develop a comprehensive plan, and (3) oversight of U.S. Coalition Support Funds (CSF) provided to Pakistan. The testimony is based on recent reports on the status of a comprehensive plan (GAO-08-622) and preliminary observations on the use and oversight of U.S. CSF (GAO-08-735R).The United States has not met its national security goals to destroy terrorist threats and close the safe haven in Pakistan's FATA. According to U.S. officials and intelligence documents, since 2002, al Qaeda and the Taliban have used Pakistan's FATA and the border region to attack Pakistani, Afghan, as well as U.S. and coalition troops; plan and train for attacks against U.S. interests; destabilize Pakistan; and spread radical Islamist ideologies that threaten U.S. interests. GAO found broad agreement that al Qaeda had established a safe haven in the FATA. A 2008 DNI assessment states that al Qaeda is now using the FATA to put into place the last elements necessary to launch another attack against America. The United States has relied principally on the Pakistani military to address its national security goals in the FATA. Of the approximately $5.8 billion directed at efforts in the FATA border region from 2002 through 2007, about 96 percent ($5.56 billion) was U.S. CSF, used to reimburse the Pakistani military. U.S. and Pakistani government officials recognize that relying primarily on the Pakistani military has not succeeded in neutralizing al Qaeda and preventing the establishment of a safe haven in the FATA. The National Strategy for Combating Terrorism (2003), independent 9/11 Commission (2004), and congressional legislation (2004 and 2007) called for a comprehensive plan that included all elements of national power--diplomatic, military, intelligence, development assistance, economic, and law enforcement support to address the threat in the FATA. Since 2002, the U.S. Embassy in Pakistan has not had a Washington-supported, comprehensive plan to combat terrorists and close the terrorist safe haven. In 2006, the United States and Pakistan began an effort to focus on other elements of national power beyond military. However, as of last month there was not a formally approved comprehensive plan and support from the recently elected Pakistani government was uncertain. Continued oversight is required to ensure the development and effective implementation of a comprehensive plan and the proper use of the billions of U.S. dollars devoted to assisting Pakistan in its efforts to combat terrorism in the FATA. Preliminary results from GAO's ongoing work on the oversight of U.S. CSF indicate that Defense may have recently increased its oversight of CSF. In 2007, Defense officials at the U.S. embassy in Pakistan--the Office of the Defense Representative to Pakistan (ODRP)--began playing a larger role in overseeing CSF reimbursement claims. Furthermore, Defense recently deferred or disallowed a larger amount of Pakistani claims. For the months September 2004 - February 2007, Defense disallowed or deferred an average of just over 2 percent of the Pakistani government's CSF claims. For the most recent claims (March - June 2007) processed in February 2008, Defense disallowed or deferred over 20 percent. The extent of ODRP's oversight in the future is unclear, given that its role has not been formalized.
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    GAO’s Evolution of Expertise and Services Over the last century, GAO has strategically adapted its services and products—all with an eye towards informing congressional decision-making and improving government operations through nonpartisan and fact-based work. GAO continues to evolve to meet the needs of Congress. From establishing a team to serve as the lead for its science and technology work, to growing its cybersecurity expertise, to developing quick-read products, GAO strives to anticipate or respond to changing congressional needs and emerging issues.  For example, one of GAO’s newest products, the “Science and Technology Spotlight,” explains emerging science and technology with its associated opportunities and challenges, and relevant policy considerations. GAO’s unique mission and structure, diverse and talented workforce, and external network makes it well-positioned to continue to support Congress into the future. The agency’s highly-skilled workforce and well-developed professional network that spans the globe enable GAO to anticipate emerging issues, challenges, and opportunities and craft strategic plans for serving the Congress and the country. GAO’s History and Impact The Budget and Accounting Act of 1921 established GAO as an independent agency to investigate how federal dollars are spent.  Early in GAO’s history, it conducted reviews of federal payments and focused on conducting financial reviews. By the 1970s, the size, scope, and complexity of the federal government had expanded, and congressional interest in whether government programs were meeting their objectives was growing. Consequently, GAO shifted its efforts to evaluating the efficiency and effectiveness of federal programs. In 2004, GAO changed its name from the General Accounting Office to the Government Accountability Office to better reflect this expanded role. Today, GAO’s work spans all federal programs and spending—from agriculture to space programs, banking regulation to public health, and cybersecurity to international aid. We also do financial audits of the US government and assessments of its fiscal outlook. The impact of this work is significant: since 2005, GAO’s findings and recommendations have resulted in $1 trillion in financial benefits and more than 21,000 operational benefits for the U.S. government. Over the past 5 years, GAO’s average return on investment is $165 for every $1 invested in GAO. In this testimony, GAO describes the wide range of services it provides to Congress, how these services have evolved to meet congressional needs, and how it is positioned to meet future needs and challenges. For more information, contact A. Nicole Clowers at (202) 512-4400 or clowersa@gao.gov.
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