April 2023

Read the Full Letter Here. 

Washington DC — Today, Protect Our Care is joining 227 leading national and state organizations in sending a letter to Secretary Xavier Becerra to urge HHS to use every tool at their disposal to enforce state and federal action to keep families in America covered as Medicaid’s continuous coverage requirement ends. At the beginning of the COVID-19 pandemic, Congress passed legislation to protect access to Medicaid by ensuring no one could be disenrolled during the public health emergency. As of April 1st, this requirement has ended, and states must re-evaluate their Medicaid rolls, which could result in millions of eligible families losing coverage due to paperwork requirements and red tape. This letter complements an effort led by Chairs of the Congressional Black Caucus, Congressional Hispanic Caucus, and Congressional Asian Pacific American Caucus calling for state and federal action to keep families in America covered as Medicaid’s continuous coverage requirement ends. Rather than join this call to protect families’ health care, House Speaker Kevin McCarthy is proposing legislation to take health care away from millions of people who rely on Medicaid to pay for doctor visits, medicine, and other essential services. 

The letter was developed and circulated by the Asian & Pacific Islander American Health Forum, the Coalition on Human Needs, The Leadership Conference on Civil and Human Rights, the National Association for the Advancement of Colored People, the National Council of Urban Indian Health, National Urban League, Protect Our Care, and UnidosUS. In it, hundreds of organizations, including civil rights groups, faith community leaders, pediatricians and family doctors, nurses, hospitals, groups representing cancer survivors and patients with serious chronic illnesses, children’s groups, women’s groups, and more urge HHS to hold states accountable to prevent historic and unnecessary health coverage losses. As it stands, an estimated 15 million people could lose Medicaid nationwide, disproportionately harming children, women, people of color, and rural residents. Specifically, the letter urges CMS to ensure the following:

• Prevent states that are violating federal law from wrongfully terminating beneficiaries for purely procedural reasons. 
• Hold state and local Medicaid agencies accountable for compliance with civil rights laws.
• Promote transparency and accountability by publishing state performance data as soon as possible.
• Hold states accountable for renewing coverage based on data matches “to the maximum extent practicable,” as the Affordable Care Act (ACA) requires for children, families, low-wage workers, people with disabilities, and older adults. 

“Nearly one million Asian Americans, Native Hawaiians, and Pacific Islanders could lose access to affordable health care,” said Juliet K. Choi, President and CEO of the Asian Pacific Islander American Health Forum. “These are real lives, hardworking families who cannot afford this catastrophic cliff merely due to red tape and administrative bureaucracy. We urge the Biden-Harris Administration, in partnership with Congress and state leaders, to do the right thing by ensuring millions of Americans, including children, do not lose Medicaid coverage.”

“Some states are intent on pushing poor people out of Medicaid, terminating health care for millions, including many who remain eligible,” said Deborah Weinstein, Executive Director of the Coalition on Human Needs. “The Biden-Harris Administration is taking important steps to prevent a huge rise in people without health care, and a critical step they must also take is to prevent terminations of coverage when states are not doing what the law requires. Millions of people are depending on the Administration to hold states accountable”

“The National Urban League has long believed that access to health insurance and affordable, accessible health care is necessary for economic empowerment,” said Marc H. Morial, President and CEO of the National Urban League. “We remain concerned about the Medicaid redetermination period and the likelihood of nearly half of Black people enrolled in Medicaid losing coverage, not because they have become ineligible, but because of red tape. We thank the Administration for the work done so far to protect these individuals and families, and urge continued action on this at the state and federal levels.”

“It is the responsibility of every state and every governor to be sure that those who qualify for Medicaid stay covered. This means helping everyone to understand their coverage options and giving them the support they need to stay enrolled,” said Leslie Dach, Chair of Protect Our Care. “No one should lose their health care because they fail to submit the right paperwork or simply because of language barriers. Instead of taking care of business by protecting families whose health care is now in danger, people who are working hard every day, people with disabilities, children, and moms, Congressional Republicans propose ripping away basic health care from millions of people who rely on Medicaid. Rather, all lawmakers should work to protect and strengthen coverage for everyone.”

“Nearly 5 million Latinos will lose their health care if state Medicaid programs go back to operating as they did before the pandemic,” said Janet Murguía, President and CEO of UnidosUS. “That would be our community’s largest health coverage loss in history. We urge the Biden-Harris Administration to do everything in its power to prevent this public health catastrophe.”

The GOP’s Debt Ceiling Package is their Most Extreme Threat to Health Care Since Their Failed Efforts to Repeal the Affordable Care Act

Burdensome Paperwork Requirements Would Rip Care Away from Lower-Wage Workers, Individuals with Disabilities, Pregnant and Postpartum Americans, and Caregivers and Burden Health Care Providers and States

The Republican plan to kick millions off Medicaid by adding burdensome work reporting requirements is their most extreme plan yet. Their plan isn’t about connecting people to jobs (research shows that Medicaid enrollees are better able to look for work and perform better at work than when they were uninsured); it’s a ploy to take away health care from millions and cut a vital social safety net they have trying to slash for years. 

• The GOP Plan Requires Over 10 million People with Disabilities to Provide a Doctor’s Note to Keep Their Health Care. The GOP plan stigmatizes people with disabilities, requiring them to seek a determination from their health care provider that they are “physically or mentally unfit for employment” in order to qualify for an exemption from work requirements. There are more than 10 million people with disabilities who rely on Medicaid. That’s over 10 million doctors’ notes every year, putting further administrative burdens on their practices at a time when health care providers are already experiencing record burnout on the heels of a pandemic.

• The GOP Plan Rips Health Care Away From Caregivers. The GOP plan would end Medicaid coverage for caregivers of adults with disabilities or chronic or temporary illnesses. For example, if an adult child needed to leave the workforce to care for an ill parent, they would lose health coverage. Additionally, the GOP plan subjects adult caregivers of children or caregivers of people who are incapacitated to burdensome reporting requirements. 

• The GOP Plan Ends Health Care For Parents Who Suffer Pregnancy Loss, Whose Child Dies, or Who Place Their Child for Adoption. Horrifically, the GOP plan would end Medicaid coverage for people when they experience pregnancy loss, stillbirth, or the death of a child, or place their child for adoption. The GOP plan also expects pregnant and postpartum people to submit paperwork to prove they are eligible for an exemption. Parents preparing to welcome a new baby and parents caring for a new baby should not be subject to even more burdensome paperwork.

• The GOP Plans Takes Coverage Away from Lower-Wage Workers. Most families (about two-thirds) who count on Medicaid include people who work full-time. People who work hard at low-wage jobs often don’t have health insurance through work so they count on Medicaid. Under the GOP plan, these adults, many of whom juggle multiple lower-wage jobs, would be required to regularly submit burdensome paperwork or they would lose their health coverage.

The GOP plan is extreme and burdensome to health care providers and states: 

• The GOP Plan Burdens Health Care Providers.  The GOP’s exemption for people with disabilities places an extreme and unethical burden on health care providers and the health care system. As written, the over 10 million people with disabilities who rely on Medicaid must be certified by their doctors or medical professionals as “physically or mentally unfit for employment.” If a medical professional is unwilling or unable to certify that a patient is entirely incapable of doing any work at all, they will lose their health insurance. A 2008 pilot program in West Virginia, imposed similar certification requirements on health care providers and prompted serious concern that these requirements violated medical ethics and could force doctors to violate their professional oaths. 

• The GOP Plan Will Burden States. States are currently undertaking an unprecedented redeterminations process following the end of the public health emergency eligibility protections. Instead of supporting states in this process, the GOP plan mandates that states shift resources toward administering burdensome paperwork requirements or lose federal Medicaid funding. If states can’t prove their Medicaid programs are not covering non-working people, states would lose their federal Medicaid funding. Adding work reporting requirements to their administrative responsibilities would be disastrous – they have limited resources that would be better spent ensuring people have coverage. 
• The GOP Plan is Their Most Extreme Plan Yet. Medicaid work requirements were a complete failure when tried in Arkansas, resulting in 18,000 people losing coverage in just 7 months, and the McCarthy plan is even more extreme. The McCarthy plan applies to every nonelderly adult enrolled in Medicaid, not just the expansion population as it did in Arkansas. The McCarthy plan includes people ages 50-55, who more commonly experience involuntary job separation that leads to long-term unemployment. The McCarthy plan does not exempt postpartum women, while the Arkansas plan exempted women in the first 60 days postpartum. The McCarthy plan also does not exempt people receiving unemployment benefits, as the Arkansas plan did.  

Watch the Full Event Here. 

Washington, DC – Today, Senate Finance Committee Chair Ron Wyden, House Assistant Democratic Leader James E. Clyburn, and Joan Alker with the Georgetown McCourt School of Public Policy joined Protect Our Care for a press conference to discuss Republicans’ radical plan to take health care away from millions of Americans. House Speaker Kevin McCarthy released the Republican plan to slash health care funding and Medicaid enrollment by imposing burdensome paperwork requirements. Read more about how Republicans are demanding health care cuts here. 

A record 92 million Americans are enrolled in Medicaid, which provides affordable care to people from all backgrounds. President Biden and Democrats in Congress are working tirelessly to protect Medicaid from GOP attacks and strengthen the program to ensure everyone has the health care they need. April marks the 5th annual Medicaid Awareness Month.

“The fact is Americans working in modestly-paid jobs often aren’t given affordable health care coverage by their employers,” said Senator Ron Wyden (D-OR). “Sometimes they’re working two or three part-time jobs. What House Republicans are essentially asking of these people, who are already on an economic tightrope, is to go out and fill out a mountain of paperwork every single month to maintain their health care. We ought to be looking at approaches that help people get more for their health care dollar.”

“Speaker McCarthy’s proposal is the demand for a ransom payment to wealthy donors and big corporations taken straight from the pockets of hard-working Americans,” said U.S. Representative James E. Clyburn (D-SC-06). “This extreme ransom demand represents everything Democrats have been sounding the alarm about: cuts to the social safety net programs, burdensome Medicaid paperwork requirements, a repeal of President Biden’s student loan relief plan, the reversal of middle class tax credits enacted through the Inflation Reduction Act, and much more. Medicaid is designed to ensure that Americans who are low-income and people living with disabilities have access to life-saving health care. Implementing unnecessary and burdensome paperwork requirements will result in just another way of kicking hard-working Americans and their families off of health insurance.” 

“These provisions are a radical attempt to cut federal funds for Medicaid and will cause millions of people to lose their coverage, not because they’re not working, but because they fail to jump over a whole new raft of bureaucratic hurdles,” said Joan Alker, Executive Director of the Center for Children and Families, Research Professor at the Georgetown McCourt School of Public Policy. “The Speaker’s bill has it backwards: having Medicaid actually supports people’s ability to work when they can get their health conditions addressed; taking their Medicaid away will only make it harder for them to work. One thing is for sure, though, if these provisions are enacted, people will lose their health insurance and any savings that accrue from this proposal will result from exactly that – people losing their health insurance.”

“Kevin McCarthy has made clear that Republicans want to hold the U.S. economy hostage in order to cut health care for millions of Americans,” said Protect Our Care Chair Leslie Dach. “The work reporting requirements proposal alone is unprecedented – applying the requirements to all of the 90 million beneficiaries, many of whom have a disability, are in a caregiver role, or have other needs that leave them unable to work. This plan opens the door for states to throw people off the rolls because they cannot keep up with the paperwork. If Republicans cared about working families, they would throw out this reckless plan and prioritize lowering health care costs, not gutting the programs that people need to stay healthy and thrive.”

The GOP Debt Ceiling Plan Includes 22 Percent in Discretionary Funding Cuts 

The House Republican default plan not only rips away health care for millions of people who rely on Medicaid, but it also cuts critical health programs by 22 percent. From funding for veterans’ health care to nursing home safety to mental health, these cuts will take desperately-needed health care away from families across the nation. As a result, more people in America will get sick and more will die. Here’s what the GOP is trying to take away from people:

1. Veterans Health Care: The GOP plan would severely cut health services for veterans delivered by the Veterans Health Administration, including inpatient, outpatient, mental health and suicide prevention, and long-term care services.
2. NIH and the Cancer Moon Shot: The GOP plan would cut NIH’s essential investments in biomedical innovation to advance cures and treatments, including the Cancer Moonshot program, Alzheimer’s disease research, research related to opioids and pain management, and a universal flu vaccine. 
3. Mental Health and Substance Use Disorder: The GOP plan would cut key programs for mental health services, including mental health resources for children. It would also cut services for substance use and prevention services, including funding aimed at combating the opioid and overdose crisis and helping pregnant and postpartum women. Additionally, the GOP plan would cut funding for the new 988 National Suicide Prevention Lifeline.
4. Community Health Centers: The GOP plan would cut discretionary funding for the Health Centers program, which provides primary and preventive care, including mental health and contraceptive care, to rural areas and other underserved people. It would also cut funding for programs that treat people living with HIV/AIDS as well as the Title X Family Planning Program.
5. Inspecting Nursing Homes: The plan would cut funding for programs that protect the Medicare Trust Fund from fraud and abuse, and inspect nursing home facilities for health and safety.
6. Addressing Shortages of Health Care Providers: The GOP plan would cut health care provider training programs for primary care physicians, nurses, behavioral health providers, and other providers that are essential for addressing our workforce shortages.
7. Addressing the Maternal Health Crisis: The GOP plan would cut the Maternal and Child Health Services Block Grant Program that serves low-income mothers and babies, as well as funding for programs that address the maternal health crisis like Maternal Mortality Review Committees. 
8. Preparing for the Next Pandemic: The GOP plan would cut programs that prepare us for the next public health emergency, including funds for vaccines and treatments, hospital preparedness, and the CDC’s funding to modernize public health data and other critical public health infrastructure needs and provide support to states and other jurisdictions.

Washington DC — Today, House Speaker Kevin McCarthy delivered a speech promoting the GOP plan to take health care away from millions of people on Medicaid and lower needed health care funding. A record 92 million people in America are covered by Medicaid, mostly seniors, children, and people with disabilities, but the GOP is seeking serious cuts to Medicaid and other vital health care programs. In his speech, McCarthy proposed bureaucratic reporting requirements, which will only result in millions losing coverage. Read more about how Republicans are demanding health care cuts here. In response, Protect Our Care Chair Leslie Dach issued a statement:

“House Republicans are intent on slashing vital health care programs, even if that means threatening the entire U.S. economy. McCarthy made it clear once again in his speech that the GOP plan is to rip away the coverage that people need to stay healthy and thrive. Their plan takes special aim at Medicaid, which 92 million Americans rely on, including people with disabilities, people with mental health and substance use disorders, children, pregnant women, seniors in nursing homes, rural Americans, and people of color. If Republicans truly cared about the state of the economy for working families, they wouldn’t put support for continued tax cuts for the wealthy before America’s health care.”

Republicans Want To Kick Millions Off Medicaid Through Bogus Work Requirements

• Across States, Expanded Medicaid Work Requirements Cut Enrollment And Increased Costs. In the handful of states that attached work requirements to Medicaid benefits, costs skyrocketed and large portions of participants lost coverage. In 2018, Kentucky withdrew a planned rollout of work requirements for Medicaid after the new restrictions were estimated to cost $271 million to implement. New Hampshire put work requirements on hold in 2019 after 40 percent of affected Medicaid enrollees almost lost coverage. In 2020, a Michigan court halted Medicaid work requirements that would have threatened 80,000 participants’ coverage. Most recently, new Medicaid work requirements in Georgia are estimated to cost up to $270 million annually—three times more than Medicaid expansion would have cost the state.
• In Arkansas, Work Requirements Failed Miserably, Causing 1 In 4 Medicaid Enrollees To Lose Coverage. In Arkansas, work requirements caused more than 18,000 people — nearly 1 in 4 of those subject to work requirements — to lose Medicaid coverage over the course of just seven months. The uninsured rate rose nearly 4% in less than a year, and a state court halted the requirements after less than two years. A group of public health experts later declared that the policy “failed to achieve its stated goal of boosting employment,” instead “harm[ing] health care coverage and access.”
• Expanded Medicaid Work Requirements Make It Harder For People To Meet Basic Needs. Millions of people in America would lose coverage if all states were required to implement Medicaid work requirements, and research suggests that work requirements could have “particular adverse effects on certain Medicaid populations, such as women, people with HIV, and adults with disabilities including those age 50 to 64.” 
• Medicaid Work Requirements Have A History Of Significantly Reducing Enrollment. Restricting access to Medicaid for adults reduces coverage for children who are still eligible, and requiring people on Medicaid to prove they are working adds an administrative burden that is hardest on low-income enrollees. The industries that employ the most Medicaid enrollees tend to have extremely volatile hours, threatening loss of coverage under expanded work requirements: “The two industries that employ the most Medicaid enrollees potentially subject to work requirements are restaurants/food services and construction; many enrollees also work at grocery stores, department stores, and discount stores or provide home health or child care services. These industries generally have above-average rates of involuntary part-time work, where employees want full-time work but can’t get it.”

Republicans Want To Take Health Care Away From Millions by Cutting Funding

• Tens of Millions of Americans are at Risk of Losing Vital Parts of Their Health Care if Cuts to Medicaid Are Pushed Through. Over 92 million Americans are currently enrolled in Medicaid. Cuts to Medicaid would surely see considerable reductions in coverage leaving millions potentially uninsured with no pathway to get health coverage.
• More Than 50 Percent Of Children Could See Significant Reductions in Their Health Coverage If Medicaid Funding Is Slashed. Nationally, 54 percent of American children are covered by Medicaid/CHIP. Slashing Medicaid funding would see many of these children become ineligible for low-cost health insurance with no pathway to finding affordable health care.
• Marginalized Groups Are Disproportionately Harmed by Republican Attacks. Increasing Medicaid access is the single most important action available to expand coverage and reduce racial inequities in the American health care system. The ACA led to historic reductions in racial disparities in access to health care, but racial gaps in insurance coverage narrowed the most in states that adopted Medicaid expansion. States that expanded their Medicaid programs saw a 51 percent reduction in the gap between uninsured white and Black adults after expansion and a 45 percent reduction between white and Hispanic adults. Cutting Medicaid and repealing the ACA’s Medicaid Expansion would result in coverage loss, and therefore inflame these disparities.
• Rural Americans Relying on Medicaid Could be Left Behind by Republicans. Nearly 14 million Medicaid enrollees reside in rural areas. Medicaid helps fund rural hospitals, which employ six percent of all employees in rural counties that report having any hospital employment. Rural hospitals in Medicaid expansion states are 62 percent less likely to close. In 2023, over 600 rural hospitals are at risk of closing in the near future.
• Nearly 45 Percent Of Adults With Disabilities Could See Reduced Health Coverage or Lose Coverage Entirely. Medicaid covers 45 percent of non-elderly adults with disabilities, including adults with physical disabilities, developmental disabilities, and brain injuries. Republican plans could leave many of these people and their families with little support and sometimes even no health coverage at all.
• Medicaid’s Assistance for Those With Substance Use Disorders Could Substantially Diminish. Nationally, around 12 percent of Medicaid enrollees over 18 have some kind of substance use disorder (SUD) and Medicaid is crucial to building a system of comprehensive substance use care. These interventions have been vital and life-saving, with one study finding that around 10,000 lives were saved from fatal opioid overdoses as a direct result of Medicaid expansion alone. Cutting Medicaid, put simply, would increase overdoses and decrease treatment options for thousands of Americans.
• Funding For Nearly Two-Thirds of Long-Term Residents in Nursing Homes Could Dry Up. Medicaid covers nursing home bills for over 60 percent of residents in nursing homes. In 2019, this totaled over $50 billion. The median private nursing home room can cost over $100,000 annually. Medicaid caps or cuts would see more seniors without the financial resources to afford long-term care.
• Births Currently Covered by Medicaid Could be at Risk. Medicaid covers over 40 percent of births in the United States and Congress recently offered permanent federal funding to states that opt to expand Medicaid coverage to mothers for one year postpartum. All of these gains would be rolled back under Republican plans and maternal mortality, already a dire crisis in this country especially for Black and Indigenous mothers, would only be worsened.
• Over a Quarter of Americans Living With a Serious Mental Health Condition Could See Their Coverage Cut Back. Medicaid is the single-largest payer for mental health services in America, serving 26 percent of all adults living with a serious mental health condition. Expanding Medicaid services, such as behavioral health benefits, also has led to improved access and better outcomes for low-income individuals. Simply having access to Medicaid has shown in some studies to reduce depression rates by over 3 percent among those with chronic health conditions. Capping or cutting Medicaid spending could see these achievements in mental health care rolled back.

A federal judge in Texas issued a ruling revoking authorization for mifepristone, a safe and effective medication essential for reproductive care that was approved by the FDA more than 20 years ago. Not only does this ruling risk barring the use of mifepristone for safe and legal abortions for millions of American women, but it lays the groundwork for any judge to be able to overrule the evidence-based and scientific FDA medication approval process, throwing the  entire system into chaos. Low-income individuals, women of color, and those without regular access to a nearby health care provider will be disproportionately harmed by these restrictions.  

The Supreme Court is expected to decide on a stay on the decision this week. Watch Protect Our Care’s event with legal and public health experts discussing the dangers of Judge Kacsmaryk’s ruling here.

Health care and legal experts overwhelmingly agree that this case is built on an unfounded legal arguments and, if Judge Matthew Kacsmaryk’s ruling stands, the consequences for patients would be disastrous. 

Physicians, Former FDA Officials, and Pharmaceutical Companies

American Medical Association: This Ruling Flies in the Face of Science. “Today’s court decision from a federal district court in Texas staying longstanding approval of mifepristone… threatens to upend access to a safe and effective drug that has been used by millions of people for more than 20 years. Additionally, this decision introduces the extraordinary, unprecedented danger of courts upending longstanding drug regulatory decisions by the U.S. Food and Drug Administration (FDA). Doing so goes against the established scientific process that leads to those decisions and puts other drugs at risk of being subject to similar efforts. Substituting the opinions of individual judges and courts in place of extensive, evidence-based, scientific review of efficacy and safety through well-established FDA processes is reckless and dangerous.” [American Medical Association, 4/7/23]

Letter from Over 300 Current and Former Pharmaceutical Industry Executives: This Decision Flies in the Face of Scientific and Legal Precedent. “On Friday, April 7, a federal judge with no scientific training fundamentally undermined the bipartisan authority granted by Congress to the Food and Drug Administration to approve and regulate safe, effective medicines for every American.  Judge Kacsmaryk’s act of judicial interference has set a precedent for diminishing FDA’s authority over drug approvals, and in so doing, creates uncertainty for the entire biopharma industry. As an industry we count on the FDA’s autonomy and authority to bring new medicines to patients under a reliable regulatory process for drug evaluation and approval. Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry. Judicial activism will not stop here. If courts can overturn drug approvals without regard for science or evidence, or for the complexity required to fully vet the safety and efficacy of new drugs, any medicine is at risk for the same outcome as mifepristone.” [Letter In Support of the FDA’s Authority to Regulate Medicines, accessed 4/18/23]

Statement from Jim Stansel, Executive Vice President of the Pharmaceutical Research and Manufacturers of America: The FDA is the Gold Standard for Determining Whether a Medicine is Safe and Effective. “PhRMA has serious concerns with any court substituting its opinion for the FDA’s expert approval decision-making. Patients and their doctors rely on the FDA to serve as an expert and trusted arbiter of what medicines are safe for use so they can make the most informed health care decisions. Moreover, undermining the FDA’s longstanding authority given to them by Congress to approve drugs would have a chilling effect on the research and development ecosystem. Biopharmaceutical researchers and scientists need certainty that FDA approvals will be upheld so they can make the long-term investments required to develop new medicines and ultimately get them approved for use by patients. At a time when medical innovation has never been more promising, it is vital we have a legal and policy environment that fosters the development of new treatments and cures and protects patients’ access to the medicines they need.” [Phrma, 4/12/23]

Pharmaceutical Companies 5th Circuit Amicus Brief: Texas Ruling Will Shatter the FDA’s Gold Standard Approvals Method. ““[T]he opinion identified no errors in FDA’s scientific judgment or calculations. Instead, the court proffered its own, competing analysis, which lacked any evidence that could support the type of rigorous scientific decision-making with which FDA is tasked. The court cast aside not only the voluminous scientific evidence FDA considered at the time of approval, but also nearly a quarter century of subsequent data showing safe and effective use of the drug. In its place, the court relied on personal stories told by plaintiffs and cherry-picked, unreliable publications—many of which were not even submitted to FDA. The court then ruled that FDA was required to refuse to approve the NDA based on the court’s own non-scientific assessment of this alternative, incomplete record.” [Pharmaceutical Companies, Executives, And Investors Brief, 4/11/23]

Former FDA Officials 5th Circuit Amicus Brief: This Ruling Puts the Country on a Dangerous Path Towards a Piecemeal Regulatory Scheme Congress Already Rejected in 1938. “Courts lack the expertise to step into FDA’s shoes by second-guessing FDA’s experts on the safety and efficacy of drugs. Assuming that role would require in expert judges to learn how to do what FDA’s expert pharmacologists, toxicologists, chemists, epidemiologists, physicians, and data scientists have spent lifetimes training to do. Getting it wrong can lead to catastrophic consequences—measured not in dollars, but in human lives— and deprive patients of life-saving medication they depend upon. FDA’s modern authority over drug approvals evolved in response to a series of public health crises that occurred over the last century. In response to these crises, Congress steadily expanded and centralized FDA’s authority over drug approvals to give FDA more discretion to protect public health. Congress codified FDA’s accelerated approval authority in 2012, when it passed the Food and Drug Administration Safety and Innovation Act.” [Brief of Former FDA Officials, 4/17/23]

Legal Scholars

Opinion of Dr. Jamie Rowen, Associate Professor of Legal Studies and Political Science, and Dr. Tami S. Rowen, Associate Professor of Obstetrics, Gynecology and Gynecologic Surgery: Ruling Heightens All the Risks Associated with Abortion. “In this case, and using the doctors’ own theory of harm, there are actually numerous benefits that the plaintiff doctors receive from having mifepristone available to pregnant people in Texas. Those who cannot access mifepristone will have to either use less effective medication regimens or will be forced to get surgical abortions at later gestational ages. Delays means the fetus continues to grow, a fact about abortion access restrictions that deeply troubled Justice Kennedy. Studies have also shown mifepristone to be helpful with labor induction, increasing the safety of the delivery process for someone who does continue with a pregnancy. Ongoing research into other applications for mifepristone may be interrupted by these judges’ decisions that limit the ways the drug can be used. [I]t is difficult to see how the FDA’s approvals of other medications are not vulnerable. For example, COVID-19 vaccines do not require an in-person doctor’s visit. Doctors who have been vocally opposed to the COVID-19 vaccine can easily find information to support arguments that they will have to care for vaccine injuries.” [PennLive, 4/17/23]

Statement from Holly Fernandez Lynch, Assistant Professor of Medical Ethics and Law: Texas Ruling is a Truly Unprecedented Decision. “What has happened in this case from the Northern District of Texas is that we have a single federal judge who has inserted himself, standing in for the agency to say FDA should have never approved mifepristone because they did not have adequate data to determine that it was safe. There was no new evidence that was presented to the court that would change FDA’s determination about whether this product meets the statutory standard for approval. What changed in this case was that ultimately the litigants were able to get their arguments in front of a federal judge.” [NPR, 4/11/23]

Statement from Khiara M. Bridge, Professor of Law: Ruling Creates Risk of Judges Reversing Other FDA Approvals. “We had accepted that federal law would preempt state law, that it would be preposterous that one federal judge in one district in Texas—or in any other state—would be able to affect the availability of a drug that had had FDA approval for 20 years. Now the things that we thought we knew about the relationship between federal law and state law, and the FDA’s ability to regulate, have been called into question. How many folks claim to have been injured by vaccines or have been injured by [being] allergic to penicillin? How many people can say they have been injured by drugs and could use those numbers as a reason to doubt the legitimacy of the approval process? We’re in really shaky territory when it comes to certainty about things that are available today.” [Wired, 4/13/23]

NAACP Legal Defense Fund 5th Circuit Amicus Brief: Texas Ruling Directly Undermines the Supreme Court and the Public Interest. “Because the district court’s opinion will impact the availability of mifepristone in all 50 states, it is contrary to the minimal assurances provided for in Dobbs. Justice Kavanaugh’s concurrence emphasized that the Dobbs decision ‘does not prevent the numerous States that readily allow abortion from continuing to readily allow abortion’ and that all states ‘may evaluate the competing interests and decide how to address this consequential issue.’ Rather than leave it to individual states to ‘readily allow abortion,’ as encouraged by Justice Kavanaugh, the district court’s order disallows the two-step medication abortion option entirely. The Supreme Court opined thirty years ago that ‘[t]he ability of women to participate equally in the economic and social life of the Nation has been facilitated by their ability to control their reproductive lives.’ Increased abortion access has had a demonstrably positive economic impact on women, and on Black women, in particular. A review of the data from 2020 among states that report racial and ethnic data on abortion patients indicates 39 percent identify as non-Hispanic Black, and among those aged 15-44 there were 24.4 abortions per 1,000 non-Hispanic Black women. When people can decide if, when, and how many children to have, they are able to make conscious determinations about other aspects of their lives.” [NAACP Legal Defense And Educational Fund Brief 4/11/23]

Insider: Washington District Judge Thomas O. Rice. Contradicts Texas Ruling, Forbidding Mifepristone Bans. “[J]ust minutes after the Texas ruling was made public, Washington State Judge Thomas O. Rice issued his own ruling on mifepristone, arguing the exact opposite of Kacsmaryk, and prohibiting the FDA from pulling the drug from the market. Rice said a nationwide injunction on the pill would be ‘inappropriate.’ The Texas lawsuit was filed by the Alliance Defending Freedom, representing a coalition of medical groups and doctors who oppose abortion. The group alleged that mifepristone is dangerous and rallied against the FDA’s initial approval of it more than 20 years ago. Meanwhile, in Washington State, several Democratic attorneys general filed a lawsuit against the FDA accusing the agency of excessively regulating the pill. The judge in the case responded by prohibiting the FDA from taking ‘any action’ that would cause the drug to ‘become less available.’” [Insider, 4/7/23]

Provider Groups

American College of Obstetricians and Gynecologists 5th Circuit Amicus Brief: The District Court Relied on Biased and Flawed Studies to Justify Ruling. “Without any form of the evidentiary hearing and in complete disregard to the overwhelming body of evidence proving that mifepristone is safe, the District Court’s order (the “Order”) purports to suspend the use of treatment essential to amici’s patients, in order to further its own ideological agenda and that of Appellees. The decision is rife with medically inappropriate assumptions and terminology. It disregards decades of unambiguous analysis supporting the use of mifepristone in miscarriage and abortion care. It relies on pseudoscience and on speculation, and adopts wholesale and without appropriate judicial inquiry the assertions of a small group of declarants who are ideologically opposed to abortion care and at odds with the overwhelming majority of the medical community and the FDA.” [Medical and Public Health Societies Brief, 4/11/23]

Doctors for America 5th Circuit Amicus Brief: Banning the Use of Mifepristone Would Endanger the Health of Patients. “An injunction reversing the approval of mifepristone would remove the availability of an evidence-based treatment that is the safest and best option for many patients. As physicians describe… the removal of mifepristone would undermine their ability to provide safe and effective management of early pregnancy loss.” [Doctors for America Brief,  2/13/23]

Over 200 Reproductive Health, Rights, and Justice Organizations 5th Circuit Amicus Brief: The District Court effectively Substituted Itself for the Agency as the Expert Evaluator of Drug Safety. “Despite the fact that the challenged approval has been in effect for over twenty years, the court—citing nothing more than plaintiffs’ assertions in their brief—declared that medication abortion causes ‘physical and emotional trauma,’ ‘mental and monetary costs,’ and death. Rather than stay this erroneous decision in its entirety, the Fifth Circuit compounded the problem. In its 2016 approval, the FDA relied on no fewer than 12 independent clinical studies, collectively representing “well over 30,000 patients,” and conclusively showing ‘serious adverse events’ at rates ‘generally far below 1.0%.’ Hundreds of additional high-quality studies conducted since mifepristone’s 2000 approval show the same.” [Brief Of Over 200 Reproductive Health, Rights, And Justice Organizations, 4/14/23]

Statement from Nancy Northup, President and CEO of the Center for Reproductive Rights: This Ruling Is Wrong on the Facts and Law. “The appellate court order repeats serious errors in Judge Kascmaryk ruling [sic]. Again, it is wrong on the facts and the law, resulting in an unprecedented override of the FDA’s scientific judgment. The court rightly found that some claims were filed too late, but that should not distract from the radical assault on the FDA’s decision-making authority and the fact that it will wreak havoc on the provision of medication abortion if it stands.” [Center for Reproductive Rights Press Release, 4/13/23]

McCarthy Addresses the New York Stock Exchange to Assure Wall Street He Has Their Back While Promising to Rip Health Care Away From Americans Who Count On It

Washington, DC — Today, House Speaker Kevin McCarthy delivered a speech promoting the GOP plan to raise costs for working families and throw people off of their health care. A record 92 million Americans are covered by Medicaid, but Kevin McCarthy confirmed that Republicans in Congress are seeking to ‘limit federal spending,’ which translates to serious cuts to Medicaid and other vital health care programs. In recent weeks, Republicans have proposed bureaucratic work reporting requirements in Medicaid, threatening to throw millions off of their coverage. Read more about how Republicans are fighting for health care cuts during Medicaid Awareness Month here. 

Protect Our Care Communications Director Anne Shoup issued the following statement: 

“Kevin McCarthy’s speech confirms that Republicans are fighting to hold our economy hostage so they can slash vital health care programs. Millions of people in this country count on Medicaid, especially people with disabilities, people with mental health and substance use disorders, children, pregnant women, seniors in nursing homes, rural Americans, and people of color. If Republicans truly cared about the state of the economy for working families, they would try to tackle rising health care costs instead of pandering to Wall Street executives and trying to rip away coverage from millions.”