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  • Understanding the Freedom of Information Act (FOIA)

    Understanding the Freedom of Information Act (FOIA)

    Background

    In November 2024, Elon Musk posted on social media, “There should be no need for [Freedom of Information Act] requests. All government data should be default public for maximum transparency.” His statement reignited discussions on the Freedom of Information Act, or FOIA, a federal law enacted in 1966 that requires federal executive branch agencies to disclose information in specific ways. Since its original passage in 1966, FOIA has been updated three times to tighten agency compliance, account for digital records, and allow citizens to request records online. Under FOIA, government agencies must disclose information by:

    • Publishing procedural rules in the Federal Register
    • Electronically disclosing certain frequently requested records
    • Disclosing all covered records not already available upon request

    FOIA includes nine exemptions to protect against harms that might result from divulging certain records; these exemptions include cases like invasion of personal privacy, information related to national security, and information that would interfere with law enforcement proceedings.

    History of FOIA

    Concerns over government secrecy grew in the aftermath of the Cold War. In response, Representative John Moss, a Democrat from California, introduced FOIA in 1955 with support from the journalism community. Despite opposition from President Lyndon B. Johnson and every federal agency, the House of Representatives passed the bill with a vote of 307–0. When Johnson signed the legislation in 1966, he included a signing statement emphasizing that the law allowed room for interpretation and exemptions related to national security.

    Over the decades, several amendments refined FOIA to make it what it is today. Most notably, the Privacy Act of 1974 was created in response to concerns about individual privacy rights In 1996, President Bill Clinton signed the Electronic Freedom of Information Act Amendments, which required agencies to make documents available electronically. The OPEN Government Act of 2007, signed by President George W. Bush, expanded the definition of “journalist” to include web-based reporters and bloggers. It also established the Office of Government Information Services to oversee FOIA compliance. President Barack Obama further reformed the law with the FOIA Improvement Act of 2016, which required agencies to update their FOIA regulations and create a centralized online portal for requests. The FOIA Improvement Act also introduced the “foreseeable harm” standard, which prohibits agencies from denying FOIA requests unless they can sufficiently prove that disclosure of the requested records would lead to a specific harm.

    The FOIA Request Process

    FOIA requests are open to anyone, regardless of citizenship status. Requesters must submit their inquiries either electronically or in paper form to the appropriate federal agency. Upon submission, the agency provides a tracking number and begins searching for relevant records. If the requested documents contain sensitive information, agencies redact sections in accordance with the nine exemptions before releasing them to the requester.

    The processing time for a FOIA request depends on the complexity of the information sought. Simple requests are generally fulfilled more quickly, while those requiring extensive searches or redactions take longer. In certain circumstances, requests may qualify for expedited processing, particularly if a delay would threaten someone’s safety or if there is an urgent need to inform the public about government activities. While there is no initial fee to file a request, agencies may charge for search time beyond two hours or for duplicating more than 100 pages, depending on the requesting party. If a request is denied, the requester has the right to file an appeal at no cost.

    FOIA in the 21st Century

    As digital technology has advanced, FOIA has become a tool for journalists and advocacy organizations to uncover government behaviors and potential wrongdoings. Some FOIA requests eventually turn into lawsuits. For example, in 2008, the American Civil Liberties Union filed a lawsuit for the Department of Justice to turn over records on the government’s use of individual cell phones as tracking devices. In 2016, Color of Change and the Center for Constitutional Rights sued the Federal Bureau of Investigation for not responding to their FOIA requests, which they had submitted that same year for records about federal surveillance of Black Lives Matter protests.

    During the Trump administration, FOIA requests were frequently used to fact-check government statements, investigate the COVID-19 response, and examine financial conflicts of interest. In 2017, federal agencies redacted or withheld 78 percent of requested records, the highest rate in a decade. That same year, FOIA lawsuits rose by 26 percent, marking a 70 percent increase from 2012. 

    Under the Biden administration, FOIA request processing remained similarly restrictive. In fiscal year 2023, over two-thirds of requests were either redacted, withheld, or denied on the basis that no relevant records were found. Agencies received nearly 1.2 million FOIA requests that year, setting a new record. Approximately 40 percent of requests were only partially fulfilled, a rate comparable to the final year of the Trump administration. Meanwhile, the number of requests fully granted dropped from 21 percent in 2020 to 16 percent in 2023.

    Arguments in Favor of FOIA

    Supporters of FOIA argue that the law promotes public transparency and holds government officials accountable for fraud, waste, and abuse. In a democratic society, access to government information is essential for maintaining trust between the public and its government. Proponents argue that government transparency is especially important in the post-9/11 era, as government agencies have expanded their data collection efforts while often keeping these activities secret.

    In addition to promoting the democratic ideal of an informed citizenry, supporters argue that FOIA is especially useful to potential voters. FOIA gives Americans access to in-depth knowledge about their political representatives, allowing them to make more informed choices at the polls.

    Finally, supporters argue that FOIA allows advocacy organizations to amplify and seek justice for government wrongdoing that would otherwise remain secret. They point to instances where FOIA requests have led to the discovery of misinformation campaigns, coordinated use of excessive force against protesters, and surveillance. In some cases, such as the aforementioned 2008 and 2016 lawsuits, FOIA requests can provide a foundation for victims of injustice to seek accountability. 

    Although FOIA initially faced challenges such as bureaucratic delays and inconsistent enforcement, proponents contend that amendments over the years have made the process more accessible. The rise of digital technology has also made it easier for agencies to share information with the public. 

    Criticisms of FOIA

    Opponents argue that FOIA places an excessive burden on federal agencies by requiring them to respond to requests within a short time frame despite limited resources and funding. They also argue that FOIA contributes to an overburdened judicial system, as courts must handle cases involving delayed or incomplete responses to FOIA requests. Another concern is that FOIA allows too many requests driven by personal curiosity rather than legitimate public interest, further straining agency resources. 

    On the other hand, some criticize FOIA’s broad exemptions, arguing that agencies frequently overuse them to withhold information. Exemption 5, which protects privileged communications between agencies, is particularly controversial. In 2013 alone, it was cited more than 81,000 times to deny FOIA requests. 

    Another longstanding issue is the excessive delay in releasing certain records. The FBI, for example, took nearly 25 years to release files on musician John Lennon following an ACLU request. The agency withheld the final 10 documents until 2006, citing concerns about “foreign diplomatic, economic, and military retaliation” against the United States. However, when the documents were finally disclosed, they contained only well-known information about Lennon’s connections to antiwar groups. ACLU legal director Mark Rosenbaum described the prolonged secrecy as “government paranoia at a pathological level.”

    Proposed Reforms

    To address some of these concerns, several reforms have been proposed to improve FOIA while balancing the government’s need for confidentiality. One suggestion is to limit the duration that records can be withheld under Exemption 5. Proponents of this reform suggest that setting a maximum withholding period of 12 years—the same limit applied to presidential records involving deliberative processes—could help prevent excessive secrecy while still protecting sensitive government deliberations. Another proposed reform is to implement a “balancing test” that requires agencies to weigh the government’s interest in confidentiality against the public’s right to access records. 

    Conclusion

    FOIA is a landmark law that changed the landscape of government transparency. While it has undergone reforms to improve public access to records, challenges such as delayed processing times and resource constraints hinder its effectiveness. Ongoing debates about FOIA reflect broader tensions regarding national security, government efficiency, and the public’s right to information. 

  • Understanding the Debate on AI in Electronic Health Records

    Understanding the Debate on AI in Electronic Health Records

    Background

    Artificial Intelligence (AI) refers to the use of computer algorithms to process data and make decisions, ultimately streamlining administrative processes. In healthcare, AI is being increasingly integrated with Electronic Health Records (EHRs)—digital systems that store and manage patient health information, such as medical history and diagnoses. By 2021, almost 80% of office-based physicians and virtually all non-federal acute care hospitals had implemented an EHR system. As part of this widespread adoption, various AI applications in EHRs are beginning to emerge. So far, the main functions of AI in EHRs include managing datasets of patient health information, identifying patterns in health data, and using these patterns to predict health outcomes and recommend pathways for treatment. 

    Arguments in Favor of AI in EHRs

    The use of AI in EHRs presents opportunities to improve healthcare by increasing efficiency as well as supplying administrative support. Supporters of AI integration argue that it can significantly improve diagnostic accuracy. AI-integrated EHR systems can analyze vast amounts of patient data, flagging potential issues that might otherwise be overlooked by human clinicians. Machine learning algorithms can identify patterns across multiple cases and recommend diagnoses or treatments based on evidence from similar cases. Proponents contend that by reducing human error and providing real-time insights, AI could support doctors in making more accurate and quick decisions, leading to better patient outcomes.

    Proponents of AI in EHRs also argue that AI has the potential to significantly reduce healthcare inequities by providing better access and more personalized care for underserved populations. AI-powered tools can identify at-risk patients early by analyzing complex data, including demographic and behavioral factors, and help prioritize interventions for those who need it most. Additionally, AI can bridge communication gaps for patients facing language barriers or low health literacy, ensuring they receive clear and relevant information about their health. Supporters also suggest that AI’s ability to reduce human biases in clinical decision-making, such as disparities in pain assessment or treatment recommendations, could lead to fairer, more equitable healthcare outcomes for all.

    From the workforce perspective, supporters argue that AI integration in EHRs has the ability to significantly reduce physician burnout by streamlining the documentation process. With the increasing time spent on EHR tasks, AI-driven tools like voice-to-text transcription, automated note generation, and data entry can cut down the time physicians devote to administrative duties. For instance, one 2023 study reported that AI integration in health records led to a 72% reduction in documentation time, equating to approximately 3.3 hours saved per week per clinician. This allows doctors to spend more time on direct patient care and less on paperwork, which supporters contend will improve job satisfaction and reduce stress.

    Arguments Against AI in EHRs

    While some argue that AI in EHRs will lead to more accurate and equitable healthcare, others raise concerns regarding data bias, privacy, and transparency. Critics of AI integration argue that modern legal frameworks lack adequate safeguards for individuals’ health data, leaving sensitive information vulnerable to breaches. For example, data collected by AI tools may be hacked or gathered without consent for marketing purposes. Additionally, certain genetics testing companies that operate without sufficient legal oversight may sell customer data to pharmaceutical and biotechnology companies.

    Moreover, some critics share concerns about whether AI integration in EHRs aligns with standards for informed consent. Informed consent is a key ethical principle that ensures patients are fully informed and in control of decisions regarding their healthcare. It includes elements such as the patient’s ability to understand and make decisions about their diagnoses, treatment options, and any risks involved. Ethical responsibility dictates that consent should be specific, voluntary, and clear. The rise of AI in healthcare applications has increased concerns about whether patients are fully aware of how their data is used, the risks of procedures, and potential errors in AI-driven treatments. Autonomy principles state that patients have the right to be informed about their treatment process, the privacy of their data, and the potential risks of AI-related procedures, such as errors in programming. Critics say that patients must be more informed about how AI is integrated into health records systems in order for them to truly provide informed consent. 

    Another significant ethical concern in the use of AI and machine learning (ML) in healthcare is algorithmic bias, which can manifest in racial, gender, and socioeconomic disparities due to flaws in algorithm design. Such biases may lead to misdiagnosis or delayed treatments for underrepresented groups and exacerbate inequities in access to care. To address this, advocates push for the prioritization of diverse training data that reflects demographic factors. They hold that regular evaluations are necessary to ensure that AI models consistently remain fair over time, upholding the principles of justice and equity. 

    Future Outlook

    Building on the potential of AI in healthcare, H.R. 238, introduced on January 7, 2025, proposes that AI systems be authorized to prescribe medications if they are approved by the Food and Drug Administration (FDA) and if the state where they operate permits their use for prescribing. This bill represents a significant step in integrating AI into clinical practices, going beyond data management to reshape how medications are prescribed and managed. The arguments for and against H.R. 238 mirror the debate around AI integration in EHRs; while proponents of the bill argue that AI could enhance patient safety, reduce errors, and alleviate clinician burnout, critics highlight concerns regarding the loss of human judgment, data privacy, and the potential for AI to reinforce biases in healthcare. As AI continues to play a central role in healthcare, bills like H.R. 238 spark important discussions about AI’s ethical, practical, and legal implications in clinical decision-making.

    Summary

    In conclusion, the integration of AI into EHRs has forced medical stakeholders to balance a need for improvements in accuracy and efficiency with a concern for medical ethics and patient privacy. On one hand, AI can support more accurate diagnoses, enhance patient care, and help reduce the burnout faced by healthcare providers. Additionally, AI may contribute to reducing healthcare inequities by providing better access and more personalized care, especially for underserved populations. However, the implementation of AI also raises concerns regarding data privacy, algorithmic bias, and informed consent, suggesting a need for more careful implementation and oversight. As AI’s presence in healthcare settings continues to expand, addressing these concerns will be key to ensuring it benefits patients and healthcare providers alike.

  • Maternal Mortality Review Committees and the PMDR Reauthorization of 2023: Key Perspectives

    Maternal Mortality Review Committees and the PMDR Reauthorization of 2023: Key Perspectives

    Introduction

    The United States faces a maternal mortality crisis, with maternal death rates significantly higher than other high-income nations. According to the CDC, maternal mortality disproportionately affects Black, Indigenous, and rural communities, with Black women experiencing maternal deaths at 2.6 times the rate of White women. The factors contributing to these disparities are complex and include unequal access to quality healthcare, socioeconomic barriers, and more. Despite advancements in healthcare, 80% of maternal deaths are preventable through timely medical intervention and comprehensive data collection. 

    What are MMRCs?

    State-based Maternal Mortality Review Committees (MMRCs) have been shown to play a pivotal role in analyzing maternal deaths to recommend evidence-based interventions. MMRCs are multidisciplinary teams that examine maternal deaths occurring during pregnancy or within one year postpartum. They utilize comprehensive data sources, including medical records, autopsy reports, and social service information. MMRCs assess preventability and contributing factors, allowing them to identify patterns and propose targeted policy solutions. Their review process centers on critical questions related to medical factors, social determinants, delays in care, and provider bias. By systematically addressing these factors, MMRCs generate insights that inform strategies to reduce preventable maternal deaths, which comprise 20% to 50% of all maternal deaths in the U.S.

    However, MMRCs face inconsistent funding and regulatory barriers, limiting their ability to track and analyze maternal deaths across states. Disparities in data collection methods and access to comprehensive patient records further hinder efforts to address maternal health inequities. Some states lack the authority to access certain medical records, while others experience delays in data sharing, reducing the timeliness and effectiveness of recommendations. Without consistent federal funding, many MMRCs struggle to maintain operations, particularly in rural and underserved areas, where maternal health disparities are often most pronounced. 

    Introduction to the Preventing Maternal Deaths Reauthorization Act

    The Preventing Maternal Deaths Reauthorization Act of 2023 (PMDR) was introduced to the House Committee on Energy and Commerce by Congresswoman Robin Kelly (D-IL) on May 18, 2023. The bill passed out of the Senate Health, Education, Labor, and Pensions (HELP) Committee in Fall 2023 and passed the House with bipartisan support in March 2024. However, the bill failed to pass the Senate before the end of the legislative calendar, rendering the bill “dead”. The reauthorization built upon the original Preventing Maternal Deaths Act of 2018, which helped establish and fund state-based Maternal Mortality Review Committees (MMRCs) to investigate maternal deaths and identify preventable causes. It sought to extend funding for MMRCs, enhance data collection, and address racial disparities in maternal health outcomes through the following provisions:

    1. Extending funding for state-level MMRCs to continue investigating maternal deaths
    2. Authorizing $58 million annually for the CDC to support state-level efforts
    3. Enhancing data collection on factors related to maternal health outcomes, particularly for minority populations
    4. Strengthening community-based interventions to reduce racial and ethnic disparities 
    5. Enhancing coordination among agencies to implement evidence-based solutions
    6. Expanding research on social determinants of maternal health 

    Arguments in Support

    Proponents of the PMDR Act of 2023 argue that the bill provides critical support for tried and true interventions to prevent maternal deaths. They emphasize that scientific literature identifies state-based MMRCs as the “gold standard” for preventing maternal deaths due to their multidisciplinary analysis. However, inconsistent funding threatens the effectiveness of MMRCs, particularly in states with high maternal mortality rates. In a letter to Congress, 125 public health and social services associations urged legislators to treat the PMDR as a top-priority bill, stressing the nation’s consistently high maternal mortality rate. Several national associations, including the American Medical Association, argue that continued federal funding is crucial to preventing maternal deaths. They highlight that past funding gaps resulted in reduced MMRC operations, hospital closures, and increased barriers to care. Supporters contend that the only way to ensure MMRCs can continue their vital work without funding disruptions is to pass the PMDR.

    Proponents of the PMDR Act also highlight its potential to promote health equity. Beyond identifying risk factors, MMRCs are critical in addressing racial, socioeconomic, and geographic disparities in maternal health by filling critical knowledge gaps on the drivers of maternal mortality in underserved populations. The PMDR Act directly supports these efforts by requiring MMRCs to report on disparities in maternal care and propose solutions. Federal support through this bill enables MMRCs to strengthen provider training, expand access to prenatal care, and address structural barriers contributing to maternal deaths. Without reauthorization, proponents argue, efforts to close maternal health gaps would be fragmented, leaving vulnerable populations without necessary protections.

    Arguments in Opposition

    The most prominent critique of the PMDR Act is that it focuses too heavily on MMRCs. Critics voiced concerns about MMRCs’ inconsistency, lack of accountability, and failure to acknowledge all social determinants of health. 

    Opponents highlight that legal and logistical challenges, such as data collection issues and lack of legal protections for participants, can create disparities in MMRC operations. Rural populations, who face higher maternal mortality rates and limited access to care, are often overlooked in MMRCs, further exacerbating disparities. Additionally, bureaucratic barriers and state laws limiting community involvement in MMRCs reduce their effectiveness in addressing maternal health challenges. 

    Others argue that MMRCs lack accountability, particularly regarding inclusivity and equitable decision-making. Advocates contend that MMRCs often exclude community representatives or organizations that challenge the status quo, prioritizing clinical expertise over individuals with lived experience. This exclusion can foster distrust, as community members may feel their knowledge and perspective are undervalued. The lack of compensation for community members to attend all-day MMRC meetings – unlike salaried clinicians – adds another barrier, further entrenching inequalities. Laws that impose burdensome requirements on MMRCs further complicate the process and reduce diversity in ideas. Opponents of the PMDR contend that these factors contribute to a lack of accountability from MMRCs, preventing them from fully creating lasting and inclusive solutions. 

    Finally, critics assert that MMRCs often fail to adequately address the underlying social determinants of health that contribute to maternal mortality. While MMRCs focus on clinical factors, such as healthcare quality and implicit bias, they can lack the frameworks to assess other social determinants like housing instability, food insecurity, or socioeconomic status. Often, these factors are deeply rooted in the broader healthcare system and community environments. Critics argue that the absence of these social factors in MMRC reviews limits the committees’ ability to develop holistic prevention solutions. Reports suggest MMRCs could benefit from incorporating a health equity framework and utilizing socio-spatial measures to address the full spectrum of challenges mothers face. Without this consideration, critics argue that MMRCs fall short of offering effective solutions to reduce maternal deaths and disparities. 

    Due to these critiques of MMRCs, critics of the PMDR argue that the bill should allocate more funding toward alternate interventions 

    Conclusion 

    The Preventing Maternal Deaths Reauthorization Act of 2023 represented an effort to extend investment in evidence-based maternal health interventions. While it received strong bipartisan support in the House, it died before a vote in the Senate, leaving MMRC funding uncertain in the years to come. While the bill was applauded for its potential to expand access to maternal care and fill critical knowledge gaps on maternal mortality factors, critics argued it placed too much emphasis on an intervention that lacked consistency and accountability to marginalized communities. 

    Future Outlook

    The Trump administration has implemented significant changes to the National Institutes of Health (NIH), including halting medical research funding and restructuring the agency, which has led to delays and uncertainties in grant approvals. These actions have raised concerns about the future of critical medical research, including studies on maternal health. Given these developments, the future of the PMDR may depend on an evolving public health funding environment. Advocacy groups and policymakers will need to collaborate to ensure that maternal health research and interventions receive the necessary support, despite the current challenges in the federal funding landscape.

  • Tulsi Gabbard Confirmed as Director of National Intelligence: Can She Keep America Safe?

    Tulsi Gabbard Confirmed as Director of National Intelligence: Can She Keep America Safe?

    In another significant development in Washington, Tulsi Gabbard—once a Democratic congresswoman, later an outspoken critic of her party, and now a key ally of President Donald Trump—has been confirmed as the Director of National Intelligence (DNI).

    Gabbard’s political journey has been anything but conventional. Born in American Samoa and raised in Hawaii, she became the youngest person elected to the Hawaii state legislature at 21. After serving in the Hawaii National Guard and deploying to Iraq, she was elected to the U.S. House of Representatives in 2012, becoming the first American Samoan and Hindu member of Congress.

    Her tenure in Congress was marked by independent positions on foreign policy, including a 2017 meeting with Syrian President Bashar al-Assad, which drew bipartisan criticism. In 2022, she announced her departure from the Democratic Party, claiming it was under the control of an “elitist cabal of warmongers.” 

    A Contentious Confirmation Process

    During her confirmation hearings, Gabbard faced intense scrutiny over her past statements and actions. Senators questioned her previous defense of Edward Snowden, whom she had once called a “brave whistleblower.” When pressed to label Snowden a traitor, she responded: “Edward Snowden broke the law.” 

    Snowden, a former NSA contractor, leaked classified information in 2013 about the U.S. government’s mass surveillance programs, including the bulk collection of American phone records under the Patriot Act. His revelations exposed the extent of the NSA’s global surveillance operations and sparked a worldwide debate on privacy, national security, and government overreach. While some view Snowden as a whistleblower who revealed unconstitutional surveillance, others, including U.S. officials, see him as a criminal who endangered national security.

    Gabbard had previously argued that Snowden deserved a fair trial rather than immediate prosecution under the Espionage Act, which does not allow whistleblowers to defend their actions in court. However, her confirmation hearing remarks signaled a shift, suggesting she would take a harder stance on intelligence leaks now that she leads the nation’s intelligence apparatus.

    Reversal on Surveillance Policies

    During her confirmation hearings, Tulsi Gabbard faced intense scrutiny over her past statements and actions. Senators questioned her previous defense of Edward Snowden, whom she had once praised for exposing illegal government activities. When pressed to label Snowden a traitor, she acknowledged that he broke the law but refrained from using the term “traitor.” 

    Regarding government surveillance, Gabbard had been a vocal critic of Section 702 of the Foreign Intelligence Surveillance Act (FISA), expressing concerns that citizens’ communications could be incidentally collected when targeting foreign nationals. 

    However, during the hearings, she indicated a shift in her stance, suggesting that with appropriate reforms, Section 702 could be a valuable tool for national security. This change led some Democrats to accuse her of political opportunism, while Republicans viewed it as a necessary evolution given her prospective role.

    Despite strong Democratic opposition, Gabbard’s nomination was confirmed by the Senate with a vote largely along party lines. 

    As Director of National Intelligence, Gabbard now oversees all 18 U.S. intelligence agencies, including the CIA, NSA, and FBI. Her appointment raises pressing questions about the future of U.S. intelligence policy. Will she uphold her past calls for transparency and civil liberties protections, or will she adopt a more traditional intelligence posture now that she’s at the helm?

    With rising global threats, cybersecurity challenges, and intense domestic political divisions, Tulsi Gabbard faces an uphill battle. The question is no longer whether she could get here. It’s whether she can succeed.

  • Understanding the Accountability for Overprescription Debate

    Understanding the Accountability for Overprescription Debate

    Background: The Opioid Epidemic

    Over the past two decades, the opioid epidemic has emerged as a key public health issue in the United States. The first wave of the epidemic was characterized by an increase in opioid prescriptions in the late 1990s paired with marketing from pharmaceutical companies that ensured that opioids were safe for pain management. In the early 2010s, a second wave arose when individuals who had become dependent on opioids sought out heroin as a cheaper and more accessible alternative for pain management. The third wave, starting in the mid-2010s, saw a rise of synthetic opioids such as fentanyl in illegal drug markets, leading to unprecedented levels of overdoses. 

    Prescription opioids are chemicals, both natural and synthetic, that are prescribed for pain management and include commonly-prescribed drugs such as Hydrocodone (Vicodin),  Oxycodone (Oxycontin, Percocet), and Morphine (Kadian). While prescription drugs are used to treat acute to chronic pain related to surgery, injury, or illness, prescription can come with risks. Side effects of commonly-prescribed opioids include increased sensitivity to pain, increased drug tolerance, and withdrawal post-medication. These side effects can lead the way to opioid misuse and addiction. In 2023, 125 million opioid prescriptions were filled in America, and 8.6 million Americans misused prescription opioids.

    Calls for Accountability

    In recent years, blame for the opioid epidemic has shifted towards pharmaceutical companies that produce the drugs and initially advertised their safety. Specifically, many consumers seek to hold pharmaceutical companies legally accountable using the argument that their deceptive marketing tactics have created a public health crisis and therefore constitute a public nuisance. Between 2014 and 2021, more than 3,000 lawsuits were raised against pharmaceutical corporations based on the public nuisance argument. However, 2021 decisions from California and Oklahoma State Supreme Courts held that false advertising was not enough to constitute a public nuisance, weakening the prospects of accountability arguments in other pending cases. 

    Most recently, the U.S. Supreme Court struck down a bankruptcy plan for Purdue Pharma – a major pharmaceutical company – that would have facilitated an $8 billion settlement to the individuals, states, and local governments that had sued the company over opioid-related deaths. While some praised the Court for its refusal to grant Purdue Pharma the bankruptcy relief it desired, others say the Court failed to hold the company accountable by jeopardizing the $8 billion settlement to victims. Today, avenues for holding major pharmaceutical corporations – collectively referred to as Big Pharma –  accountable are highly debated. 

    The Case for Holding Big Pharma Legally Accountable

    Supporters of holding pharmaceutical companies legally accountable for the opioid epidemic cite the companies’ use of deceptive marketing techniques to sell opioids. For example, Purdue Pharma’s Evolve 2 Excellence initiative aimed to increase the sale of OxyContin by instructing their marketing team to promote higher dosages and target high volume opioid prescribers. In 2003, Purdue Pharma launched a misleading marketing campaign about the effectiveness of their prescription drugs despite a lack of proven efficacy in treating pain. In 2014, the city of Chicago sued Janssen Pharmaceuticals, Cephalon, Purdue Pharma, Endo Health Solutions, and Actavis for “knowingly and aggressively marketing [opioids] as rarely addictive” and contributing to several Chicagoan overdose deaths. 

    Proponents of legal accountability for Big Pharma believe that successful lawsuits against major pharmaceutical companies could set important precedents and ensure that other corporations are held accountable for their public health impacts on the US population. When polled, 57% of Americans believed that pharmaceutical companies should be held legally and financially accountable for the worsening opioid crisis. This belief existed across party and ideological lines. An even larger segment of the U.S. population supports compelling Big Pharma to remedy their contributions to the epidemic in other ways, with 73% stating that they want drug companies to fund opioid addiction treatment and 72% arguing that they should distribute naloxone kits for free. 

    Arguments Against Legal Accountability for Big Pharma

    Critics of legal accountability for pharmaceutical corporations argue that lawsuits are temporary solutions that will not deter pharmaceutical companies from producing and marketing harmful drugs in the long term. They hold that given the massive annual profits of the top five pharmaceutical companies, civil suits act as no more than a slap on the. Critics also emphasize the increasing difficulty of using the public nuisance argument against Big Pharma due to the complexities of state and federal oversight.

    Additionally, some opponents of legal accountability for Big Pharma argue that highly-publicized lawsuits only provide a false sense of closure and ignore other factors that underlie the opioid crisis. Critics believe there are multiple causes of the opioid epidemic such as housing and food insecurity, and thus argue that the social determinants of health framework must be adopted in order to best tackle the crisis. Mimi Walters, former United States Representative, discussed how prioritizing settlements with pharmaceutical companies is illogical if people are not simultaneously addressing unfair federal housing programs that create barriers to housing for those who have substance use disorders. Citing lack of economic opportunity, limited drug treatment, and need for pain management as causes of opioid overuse, some believe taking a holistic approach is the only way to manage the opioid crisis from the grassroots. They contend that legal settlements are simply a bandaid solution.

    Moreover, some argue that overprescribing doctors hold just as much responsibility for the opioid epidemic as the corporations that market the drugs. Patient satisfaction and expectations for pain-free experiences have become central to the healthcare industry, leading some doctors to prescribe strong opioids for slight injury rather than saving them for persistent, chronic pain. Critics believe that this push for patient satisfaction, along with a focus on the monetary value of patients, creates a cycle in which physicians prescribe to make money. Opponents also cite the Food and Drug Administration’s (FDA) lack of regulation as a contributing factor. In 2017, the Presidential Commission on Combating Drug Addiction and the Opioid Crisis found that the epidemic was partially caused by gaps in FDA oversight. In 2002, 8 out of 10 members of an FDA advisory committee on opioid prescription had ties to Big Pharma. The committee advised the FDA against regulating overprescription, causing many to argue that accountability efforts should include government agencies and not just corporations.

    Conclusion

    Efforts to hold pharmaceutical companies legally accountable have gained traction in recent years. In 2023, Michigan became the last state in the nation to repeal its legal immunity for pharmaceutical companies. In October 2024, the U.S. Department of Justice brought charges against several pharmaceutical companies and brokers for their role in the unlawful distribution of nearly 70 million opioid pills. While many applaud these efforts, some see them as short-term solutions and argue they must be part of a larger comprehensive approach to address the far-reaching consequences of the opioid epidemic in the years to come.

  • Protecting Our Democracy Act: Weighing the Pros and Cons

    Protecting Our Democracy Act: Weighing the Pros and Cons

    Background

    The Protecting Our Democracy Act (PODA) is a bill under consideration in Congress that aims to protect the integrity of the democratic process. The bill was originally passed in the House in 2021. It was received in the Senate in late 2021, where it failed to pass due to the use of a filibuster. It was reintroduced to the House in 2023, where it remains.

    PODA’s provisions center around three main goals:

    • Shifting power from the executive to the legislative branch: PODA would limit presidential powers, reassert Congress’s constitutional authority over federal spending decisions, and require congressional approval of presidential emergency declarations. PODA would also codify Congress’s subpoena and investigatory power, giving the legislative branch greater oversight of the executive branch.
    • Preventing corruption: PODA would require greater presidential transparency, enact new protections for both inspectors general and whistleblowers, and codify the Constitution’s Emoluments Clauses, which prevent government officials from receiving profits from foreign officials or states. It would also reinforce the Hatch Act of 1939, which limits the political activities of federal employees and other government officials involved with federally-funded programs.
    • Strengthening election integrity laws: PODA also prohibits foreign election assistance in the form of donations and would require greater transparency in digital political advertisements.

    Arguments in Favor of the Protecting Our Democracy Act

    One of the main arguments in support of PODA is that gradual institutional decay has undermined congressional authority. PODA’s proponents point to resistance to congressional oversight by former Presidents Donald Trump and Barack Obama as evidence of this phenomenon. They argue that the recent growth of the executive branch at the expense of the legislative branch can be mitigated through PODA’s provisions, which give Congress clear authority to enforce subpoenas, reassert congressional power over federal spending, and restrict a president’s use of emergency declarations. Proponents believe that this would effectively reform the balance of power between the two branches and restore the democratic process to the federal government.

    PODA’s supporters also emphasize a need for greater defenses against corruption and abuses of power. They point to the Trump administration’s refusal to disclose tax returns, dismissals of inspectors general, and issuance of pardons for corruption charges against close associates as evidence of the need for greater oversight of the executive branch. They believe that reinforcing the Hatch Act would keep federal programs fair and non-partisan, reduce corruption, and prevent political patronage. Supporters also believe that government whistleblowers need greater protections. A poll conducted by Marist in 2020 found that 86% of American voters agree that there should be more legal protections for federal employees who report fraud. Whistleblower protections are also popular across party lines. Supporters of PODA believe that the bill would provide these popular protections by granting whistleblowers increased anonymity and a private right of action if outed by other government officials.

    Finally, proponents of PODA argue that the bill will prevent foreign interference in elections. The federal ban against foreign interference in national elections has not been updated since the Supreme Court’s 2010 Citizens United v. FEC decision, which allowed corporations and other organizations to spend unlimited amounts of money on campaigns and elections. PODA’s supporters believe that this outdated policy has allowed foreign interests to fund campaigns, pay for digital advertising, and conduct social media campaigns freely, potentially spending almost $1 billion total on U.S. elections in the past decade. If passed, the bill intends to decrease foreign influence by explicitly banning foreign assistance in elections and requiring political groups to report all attempts by foreign actors to influence campaigns or elections.

    Arguments Against the Protecting Our Democracy Act

    The main argument against PODA is that the bill interferes with the separation of power between the three branches of government. Opponents of PODA argue that its provisions diminish the executive branch by requiring congressional oversight of the presidential pardon, a constitutionally-granted presidential power. Critics also believe that PODA would diminish the judicial branch by attaching new definitions to constitutional language that courts have already ruled upon, overriding court decisions and further upsetting the balance of power. Specifically, they point to PODA’s new definition of emoluments, which expands the definition to include payments arising from commercial transactions at fair market value. In light of this, opponents believe that PODA’s passage would upset the American political system of checks and balances by tipping the scales too far in the direction of the legislative branch.

    Opponents of PODA also point to the bill’s protections for whistleblowers and inspectors general as a key reason to oppose the proposal. They believe that the increased protections and anonymity for whistleblowers make it difficult for the federal government to vet claims, shielding poorly-performing employees from scrutiny. They also believe that requiring congressional oversight for firing Inspectors General decreases government efficiency and intrudes on internal operations.

    Critics also believe that PODA is politically-motivated. They argue that the bill specifically targets former President Trump and his administration’s actions. As such, they believe that PODA’s proponents only support it with the intent of politically damaging Trump and that the bill’s provisions are unnecessary.

    Conclusion

    In summary, PODA supporters argue that the bill would restore congressional authority, defend against government corruption and abuses of power, and prevent foreign interference in elections. Critics argue that PODA is a politically-motivated bill that would interfere with the constitutional separation of powers, make it difficult to vet whistleblower claims, and decrease the efficiency of the federal government. 
    After its introduction to the Senate in December 2021, PODA entered committee, where it has remained for the last three years. Even with its recent reintroduction to the House, it is unlikely to pass the Senate in its entirety unless the filibuster is abolished.