Tag: accountability

  • 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. 

  • 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.

  • Pros and Cons of California SB-1047: The AI Regulation Debate

    Pros and Cons of California SB-1047: The AI Regulation Debate

    Background

    With the recent emergence of ChatGPT, artificial intelligence (AI) has transformed from an obscure mechanism to a widely-used tool in day-to-day life. Around 77% of devices integrate some form of AI in voice assistants, smart speakers, chatbots, or customized recommendations. Still, while at least half of Americans are aware of AI’s presence in their daily lives, many are unable to pinpoint how exactly it is used. For some, the rapid growth of AI has created skepticism and concern. Between 2021 and 2023, the proportion of Americans who expressed concern about AI increased from 37% to 52%. By 2023, only 10% of Americans were more excited than concerned about AI applications in their day-to-day lives. Today, legislators at the federal and state level are grappling with the benefits and drawbacks of regulating AI use and development. 

    California’s SB-1047: An Introduction

    One of the key players in AI development is the state of California, which houses 35 of the 50 most prominent AI companies in the world. Two cities in California, San Francisco and San Jose, account for 25% of all AI patents, conference papers, and companies worldwide. California has responded to the growing debate on AI use through legislative and governmental channels. In 2023, Governor Gavin Newsom signed an executive order establishing initiatives to study the benefits and drawbacks of the AI industry, train government employees on AI skills, and work with legislators to adapt policies for responsible AI development. 

    One such policy that gained attention is SB-1047, or the Safe and Secure Innovation for Frontier Artificial Intelligence Models Act. The bill passed both chambers of the state legislature, but was vetoed by Governor Newsom in September 2024. Introduced by state senator Scott Weiner of San Francisco, SB-1047 aimed to establish safeguards in the development of large-scale AI models. Specifically, the bill applied to cutting-edge AI models that use a high level of computing power or cost more than $100 million to train. Its key provisions included:

    • Cybersecurity protections: Requires developers to take reasonable cybersecurity precautions to prevent unauthorized access to or unintended use of the AI model
    • Pre-release assessment: Requires developers to thoroughly test their AI model for potential critical harm before publicly releasing it. Establishes an annual third-party audit for all developers
    • “Kill switch”: Requires developers to create a capacity to “promptly enact a full shutdown” of the AI program in the case it risks damage to critical infrastructure
    • Safety protocol: Requires developers to create a written safety and security protocol, assign a senior professional to implement it, publish a redacted version, and send an unredacted version to the U.S. Attorney General upon request
    • Whistleblower protections: Prohibits developers from retaliating against employees who report violations of safety protocol internally or to government officials
    • CalCompute: Establishes a publicly-owned and -operated cloud computing infrastructure to “expand access to computational resources” for researchers and startups

    Pros of SB-1047

    One of the main arguments in favor of SB-1047 was that the bill encouraged responsible innovation. Proponents of the bill emphasized that it aligned with federal policy in targeting large-scale systems with considerable computing power, which pose the highest risk of harm due to their cutting-edge nature. They argued that the bill’s holistic approach to regulation, including preventative standards like independent audits and response protocol like the “kill switch” provision, make it difficult for developers to simply check a box stating they do not condone illegal use of their AI model. 

    Proponents also applauded the bill’s protections for whistleblowers at companies that develop advanced AI models. Given the lack of laws on AI development, general whistleblower protections that safeguard the reporting of illegal acts leave a gap of vulnerability for AI workers whose products are largely unregulated. Supporters say SB-1047 would have filled this gap by allowing employees to report potentially dangerous AI models directly to government officials without retaliation. In September 2024, over 100 current and former employees of major AI companies – many of which publicly advocated against the bill – sent a letter to Governor Newsom in support of the legislation’s protections. 

    Other supporters were enthusiastic about the bill’s establishment of CalCompute, a cloud computing infrastructure completely owned and operated by the public sector. Advocacy group Economic Security California praised CalCompute as a necessary intervention to disrupt the dominance of a “handful of corporate actors” in the AI sector. Other advocates emphasized that CalCompute would complement, rather than replace, corporations in providing supercomputing infrastructure. They argued that the initiative would expand access to AI innovation and encourage AI development for public good. 

    Another key argument in favor of SB-1047 is that the bill would have created a necessary blueprint for AI regulation, inspiring other states and even the federal government to implement similar protections. By signing the bill into law, proponents argue, California would have become the “first jurisdiction with a comprehensive framework for governing advanced AI systems”. Countries around the world, including Brazil, Chile, and Canada, are looking at bills like SB-1047 to find ways to regulate AI innovation as its applications continue to expand. 

    Cons of SB-1047

    SB-1047 received criticism from multiple angles. While some labeled the bill an unnecessary roadblock to innovation, others argued for even stronger regulations.

    On one hand, the bill’s large scope was criticized for focusing too heavily on theoretical dangers of AI, hindering innovation that might lead to beneficial advancements. Opponents contended that some of the language in the bill introduced hypothetical scenarios, such as the creation and use of weapons of mass destruction by AI, with no regard to their low plausibility. Major companies like Google, Meta, and OpenAI voiced opposition to the bill, warning that the heavy regulations would stifle productivity and push engineers to leave the state. 

    Others criticized the bill for its potential impacts on academia and smaller startups. Fei-Fei Li, co-director of Stanford University’s Human-Centered AI Institute, argued that the regulations would put a damper on academic and public-sector AI research. Li also stated that the bill would “shackle open source development” by reducing the amount of publicly available code for new entrepreneurs to build off of – a fear that was echoed by national lawmaker Nancy Pelosi (D-CA).

    On the other hand, some believe the bill did not go far enough in regulating cutting-edge AI. These critics pointed to provisions that exempt developers from liability if certain protocols are followed, which raised questions for them about the bill’s ability to hold developers accountable. They also criticized amendments that reduced or completely eliminated certain enforcement mechanisms such as criminal liability for perjury, stating such changes catered to the interests of large tech corporations. Critics argued that the bill’s vague definitions of “unreasonable risk” and “critical harm” leave ample room for developers to evade accountability. 

    Given the bill’s sweeping language in key areas, critics worried that it could either overregulate, or fail to regulate, AI effectively.

    Recent Developments

    On February 27th, 2025, SB-1047 sponsor Scott Weiner introduced a new piece of legislation on AI safety. The new bill, SB-53, was created with a similar intention of safeguarding AI development, but focuses specifically on the whistleblower protection and CalCompute provisions of the original bill.  

    While California continues to grapple with state-level regulations, the federal government has also taken steps to address AI. The Federal Communications Commission is using the 1980s Telephone Consumer Protection Act to restrict AI-generated human voices. The Federal Trade Commission has warned against AI misuse, including discrimination, false claims, and using AI without understanding its risks. In 2024, the Office of Management and Budget issued AI guidelines for all federal agencies. Later that year, the White House formed an AI Council and the AI and Technology Talent Task Force. Although no federal legislation has been passed, these actions show a growing focus on AI regulation.

    Conclusion 

    California’s Safe and Secure Innovation for Frontier Artificial Intelligence Models Act aimed to regulate AI development through novel safeguards. While it was applauded by some as a necessary response to an ever-evolving technology, others believed its wide regulations would have stifled innovation and entrepreneurship. As AI’s use and applications continue to evolve, new policy solutions are likely to emerge at both a state and federal level in the future. 

  • 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.

  • The “Let Pregnancy Centers Serve Act” of 2024: Key Insights and Implications

    The “Let Pregnancy Centers Serve Act” of 2024: Key Insights and Implications

    What are Crisis Pregnancy Centers?

    Crisis pregnancy centers (CPCs) are nonprofit, community-based organizations that aim to ensure pregnant people carry their pregnancy to term. CPCs provide services, including pregnancy tests, ultrasounds, baby formula, and diapers to achieve their mission. While they have operated in the U.S. for decades, CPCs have become more prominent in the public eye in light of the Supreme Court’s Dobbs v. Jackson decision that overturned the national right to abortion. Contention has emerged concerning whether CPCs should continue to receive federal funding and qualify as eligible healthcare centers for patients using federal healthcare assistance programs. 

    Introduction to the Let Pregnancy Centers Serve Act of 2024

    The Let Pregnancy Centers Serve Act of 2024 was introduced to the Senate Committee on Finance by Senator Cindy Hyde-Smith [R-MS] on January 18, 2024, and is currently in the introduction stage. The Act contains two central provisions:

    1. Maintaining TANF Eligibility: Temporary Assistance for Needy Families, or TANF, is a government program that provides financial assistance to pregnant people and families for the purpose of accessing food, housing, healthcare, and other necessities. States have autonomy in implementing TANF, including determining the type and amount of assistance payments, and the services that can be obtained with TANF funds. The Act would ensure that people who receive TANF can use their benefits to pay for CPC services, and that CPCs can continue to receive TANF-delegated funding from the federal government.
    2. Renewing federal funding: The Act would prevent the federal government from denying CPCs funding via grants, on the basis that doing so merits federal discrimination against grantees. 

    Arguments in Support of the Let Pregnancy Centers Serve Act of 2024

    Enhanced Access to Pregnancy Services

    Proponents of the Act argue that PCPs should be praised for the broad range of goods and services they provide at little to no cost, such as baby clothes and formula. Early pregnancy confirmation is cheaper and more accessible at a CPC than at an abortion clinic, which supporters argue increases accessibility. They cite a study that showed that patients without health insurance were significantly more likely to visit a CPC than not to visit a CPC during their pregnancy. Additionally, proponents believe that the educational programs provided by some centers, such as parenting classes and prenatal care, help equip new and expecting parents with necessary knowledge and skills. In addition, some CPCs offer different types of emotional and psychological support. Advocates of the Act believe that the counseling services provided by some centers can help individuals and families navigate the pregnancy experience and its complexities. 

    Protection from Federal Discrimination

    One of the primary objectives of the Act is to ensure that CPCs continue to receive TANF funding. The bill aims to prevent the Biden administration’s proposed rule that would reduce or cut TANF funding to CPCs. Proponents argue that these centers play a crucial role in providing support to pregnant women, and that losing TANF funding eligibility could significantly impact their ability to offer essential services. Advocates of the bill argue that protection against federal discrimination is crucial for maintaining the viability of CPCs and ensuring they can continue to provide their service without undue interference. Advocates emphasize that CPCs have been allowed to receive federal funding since 1996, and that reversing this practice signals federal discrimination on a national scale. Proponents also argue that states should have the flexibility and power to direct funds to organizations that align with their values and priorities, and that the federal government would infringe upon state’s rights by prohibiting funding to CPCs nationally. 

    Arguments Against the Let Pregnancy Centers Serve Act of 2024

    Misleading Patients 

    Opponents of the Act argue that CPCs provide misleading or incomplete information about reproduction with the goal of preventing patients from seeking abortion, which can impact patients’ ability to make informed decisions about their health. Most crisis pregnancy centers have a religious affiliation and are not medically licensed, and thus fall outside the scope of consumer protection regulations that are designed to protect patients. Opponents argue that CPCs purposefully and unethically market themselves as health clinics, which has led to the development of websites like ExposeFakeClinics.com and The Anti-Abortion Pregnancy Center Database to warn patients about CPCs in their area. 

    Critics also claim that many ethical concerns that arise when the government provides TANF funding to organizations that are unqualified to provide medical advice. In particular, critics argue that CPCs’ main goal is to discourage or delay women from seeking abortion services, and that providing them with TANF funding could lead patients to perceive them as legitimate and objective healthcare providers. Delays in medical care, whether it be prenatal checkups or appointments about different options, can lead to more complex and costly procedures later on, and potentially put pregnant people’s lives at risk. Critics believe that by prioritizing funding for un-licensed pregnancy centers, the government risks misleading pregnant people into seeking services at centers with no medical credentials and thus neglecting their healthcare needs.

    Misuse of Federal Funds

    Additionally, opponents of the Act are concerned that CPCs lack the oversight and accountability required of other TANF-eligible medical facilities, which could increase the risk of mismanaged or ineffectively-used federal funds. While states must spend TANF funding on programs that achieve one of four TANF purposes, some argue that CPCs are deceptive and lack patient-centered care. Critics of the Act believe that TANF dollars could be used in more efficient ways than funding CPCs, such as promoting job preparation and work. They believe that funding CPCs risks diminishing government funds that could be used to fund prenatal care, contraceptive counseling, and more comprehensive maternal health services. Many believe that allowing TANF funds to support CPCs could weaken the overall monetary support network for reproductive health in the nation. 

    Conclusion

    The Let Pregnancy Centers Serve Act of 2024 aims to protect crisis pregnancy centers by allowing states to allocate TANF and other federal grant funds to these centers without federal interference. Supporters argue that CPCs offer vital services that deserve protection and uphold states’ rights to manage their grant distributions. Conversely, opponents express ethical concerns about funding centers that lack medical qualifications, licensure, and oversight. Critics warn that the Act could misallocate federal funds, diverting resources from licensed maternal and contraceptive care programs to less regulated centers. The legislation’s outcome will significantly impact pregnant individuals nationwide.