News

Mifepristone Case Threatens Health and Safety of Millions of Patients and to Disrupt Entire Drug Approval Process  

Washington, DC — Today, Justice Samuel Alito issued an administrative stay of Judge Matthew Kacsmaryk’s ruling invalidating the FDA’s approval of mifepristone. This will allow the plaintiffs time to respond to the Justice Department’s request for a full stay of the ruling and for the court to make its decision on the stay request. Not only does the case threaten safe and legal abortion access, but it lays the groundwork for any judge to be able to overrule the evidence-based and scientific FDA medication approval process. The consequences of Judge Kacsmaryk’s ruling will be most detrimental for women of color, people living in rural areas, and poorer Americans who face the steepest barriers to accessing care. 

Watch Protect Our Care’s event with legal and public health experts discussing the dangers of Judge Kacsmaryk’s ruling here. In response, Protect Our Care Communications Director Anne Shoup issued the following statement: 

“This case is one of the single greatest threats to American health care today. Not only does it seek to undermine patients’ access to safe and legal abortions, but it threatens to throw the entire U.S. drug approval process into chaos. It opens the door to politically-motivated lawsuits seeking to remove or greatly restrict the availability of other safe and effective drugs. If the ruling stands, millions of patients will suffer, and the Supreme Court must issue a full stay of the district court’s decision.”

Watch the Event Here.

Washington, DC — Today, U.S. Representatives and Co-Chairs of the Medicaid Expansion Caucus joined Protect Our Care for a press conference discussing the urgency for the remaining 10 non-expansion states to follow North Carolina’s lead and finish the job to extend coverage to the estimated 1.9 million Americans in the coverage gap. During the call, the speakers discussed how expansion has never been more important as states face threats of major coverage losses due to the ongoing Medicaid unwinding.

“Every day we don’t expand Medicaid in Georgia is a day we lose out on millions in federal investments to our state but more importantly thousands of Georgians who lose out on life-saving, affordable health care,” said U.S. Representative Hank Johnson (D-GA-04). “It’s really tragic that some Georgians actually lose their lives because they don’t have access to the health care system. Our legislature needs to expand Medicaid in our state. It’ll help about 650,000 Georgians access the health care system.” 

“We have over 100,000 Tennesseans who are not getting Medicaid who could get it and Tennessee would receive $900 million over two years from the federal government,” said U.S. Representative Steve Cohen (D-TN-09). “This would not only be good for the health of Tennesseans but the health of poor Tennesseans who otherwise don’t get treated and for our rural hospitals, many of which have closed.”

“I’m really glad to see that we’re on a positive pathway towards expanding Medicaid in North Carolina. And now as a voice in Congress, I will continue to fight for all Americans that remain trapped by their states in the Medicaid coverage gap,” said U.S. Representative Don Davis (D-NC-01). “We must incentivize other non-expansion states to move forward and provide life-saving health care coverage to nearly 2 million Americans in need.”

“It is long past time that Republicans stop threatening cuts to Medicaid,” said Protect Our Care Executive Director Brad Woodhouse. “People desperately need health care. It shouldn’t be a partisan issue. It shouldn’t have been a partisan issue all these years. It’s simply just time to get it done.”

Washington, DC — Last night, the Fifth Circuit issued a partial stay of Judge Matthew Kacsmaryk’s ruling invalidating the FDA’s approval of mifepristone.The Justice Department announced today that it would ask the U.S. Supreme Court for a full stay of the ruling. While the court’s decision does not entirely bar access to mifepristone, it dramatically restricts access to the drug. This case lays the groundwork for any judge to be able to overrule the evidence-based and scientific FDA medication approval process. The consequences of this ruling will be most detrimental for women of color, people living in rural areas, and poorer Americans who face the steepest barriers to accessing care. Watch Protect Our Care’s event with legal and public health experts discussing the dangers of Judge Kacsmaryk’s ruling here. In response, Protect Our Care Communications Director Anne Shoup issued the following statement: 

“Despite issuing a partial stay, the 5th Circuit is still undermining patients’ access to safe and legal abortions and threatening to throw the entire U.S. drug approval process into chaos. It not only puts at risk the use of mifepristone, but it opens the door to politically-motivated lawsuits seeking to remove or greatly restrict the availability of other safe and effective drugs. If the ruling stands, millions of patients will suffer, and the Supreme Court should issue a full stay of the district court’s decision.”

This week we highlight the upcoming Black Maternal Mortality Week of action, new Centers for Medicare and Medicaid (CMS) rules on Medicare Advantage focusing on improving health equity, the 75th anniversary of the World Health Organization as well as its heightened focus on reducing health disparities, and new private ventures aimed at addressing underserved rural communities in the South where Republican legislators often exacerbate inequities through their apathy towards state action. While progress is continuing to be made, there is also mounting evidence that the radical Republican agenda in state legislatures, the Courts, and within Big Pharma is undermining measures and policies which have saved countless lives and empirically reduced health disparities across the board.

Protect Our Care is dedicated to making high-quality, affordable and equitable health care a right, and not a privilege, for everyone in America. We advocate for policies that lower health care costs and strengthen coverage, which are critical to expanding access to quality health care and, ultimately, achieving better health outcomes, particularly for people of color, rural Americans, LGBTQI+ individuals, people with disabilities, and more. Our strategies are driven by a broader commitment to tackling systemic inequities that persist due to racism and discrimination and the reality that multi-sector policies are needed to address basic conditions that affect health and related outcomes, particularly for marginalized communities.

INITIATIVES

The White House: A Proclamation on Black Maternal Mortality Week. “Studies show that Black women are often dismissed or ignored in hospitals and other health care settings, even as they suffer from severe injuries and pregnancy complications and ask for help. Systemic inequities are also to blame. When mothers do not have access to safe and stable housing before and after childbirth, they are at greater risk of falling ill. When women face barriers traveling to the hospital for prenatal and postpartum checkups, they are less likely to remain healthy. Air pollution, water pollution, and lead pipes can have dangerous consequences for pregnant women and newborns. And when families cannot afford nutritious foods, they face worse health outcomes. Vice President Kamala Harris has been a leader on the issue of maternal mortality for years and led the charge to improve maternal health outcomes, including by issuing a call to action to address disparities in maternal care. She continues to elevate the issue nationally, convening State legislators, medical professionals, and others so all mothers can access the care they need before, during, and after childbirth. This week, as we continue our work to make pregnancy and childbirth safe, dignified, and joyful for all, let us remember that health care should be a right and not a privilege. Let us give thanks to the extraordinary maternal health care workforce, which serves its patients and their families every day. And let us join in common cause to end the tragedy of maternal mortality once and for all.” [The White House, 4/10/23]

The Ford Foundation: Dom Kelly’s A New Disabled South is Working on Increasing Equity and Access in the Southern U.S. “New Disabled South is a coalition of disability justice activists, advocates and organizations working across the South. The South is home to one third of all disabled people in the United States. Because people with disabilities live at the intersection of all systems of inequality, they are impacted by the problems that plague the South—from high poverty levels to an incredibly harsh criminal justice system—all the more. Today, New Disabled South is working across 14 states to lift our people out of poverty, remove barriers that disabled people face when voting, end the criminalization of Black disabled people, and more. Of the millions of disabled people living in poverty, the majority of the population in the South are BIPOC. We know that 8 out of the 12 states that have yet to expand Medicaid are in the South, and that means that hundreds of thousands if not millions of disabled people are without access to affordable health care. Fifty percent of people killed by law enforcement in the U.S. are disabled, and more than half of disabled Black men have been arrested by the time they turn 28—double the risk in comparison to their white disabled counterparts.” [The Ford Foundation, 4/3/23]

The World Health Organization: WHO Celebrates 75th Anniversary and Calls for Increased Focus on Health Equity. “WHO is urging countries to take urgent action to protect, support and expand the health workforce as a strategic priority. Investments in education, skills and decent jobs for health need to be prioritized to meet the rapidly growing demand for health and avert a projected shortage of 10 million health workers by 2030; primarily in low- and middle-income countries. A global education programme on basic emergency care targeting 25% of nurses and midwives from 25 low- and middle-income countries by the end of 2025 was also recently announced by WHO. In the shadow of the COVID-19 pandemic, WHO’s roadmap to recovery includes an urgent paradigm shift towards promoting health and well-being and preventing disease by addressing its root causes and creating the conditions for health to thrive. WHO is urging countries to provide health by prioritizing primary health care as the foundation of universal health coverage.” [The World Health Organization, 4/3/23] 

Modern Healthcare: CMS Announces Final Rule on Medicare Advantage. “The Centers for Medicare and Medicaid Services’ Medicare Advantage and Medicare Part D final rule for 2024 aims to further the agency’s efforts to strengthen federal oversight of health insurance companies. CMS published the regulation Wednesday, which includes major changes to the standards for quality metrics, prior authorizations, marketing and health equity. CMS received nearly 40,000 marketing misconduct complaints from beneficiaries in 2021, a 157% increase over the prior year, the agency previously reported. Based on this evidence of growing problems, the final rule imposes new restrictions on marketing by health insurers, brokers and others. CMS will replace the reward factor with a health equity index and reduce the weight of patient experience and complaints on quality scores. The health equity provisions and other aspects of the regulation are intended to reward health insurance companies for ensuring people from underserved communities receive quality care. Insurers must halve the length of time they take to respond to prior authorization requests and extend approvals through the full course of a patient’s treatments, and may no longer require preapproval for emergency behavioral healthcare. In addition to including a health equity metric in the Star Ratings program, the final rule requires Medicare Advantage insurers to provide access to healthcare in a “culturally competent manner” by including the languages providers speak in network directories, offering digital health education and addressing health disparities in quality improvement programs. The regulation also implements prescription drug pricing provisions from the Inflation Reduction Act of 2022.” [Modern Healthcare, 4/5/23]

CHALLENGES

The New Republic: The ACA Requires Insurers to Not Deny Coverage for Contraceptives, Insurers are Doing it Anyways. “The Affordable Care Act, or ACA, was signed into law 13 years ago, but some provisions of the landmark health care legislation regarding contraceptive care are still unenforced. Although the ACA requires that health plans cover contraceptive care without cost-sharing, several million patients still face hurdles to accessing certain products, with companies using outdated federal guidance to justify the lack of coverage. That’s according to a letter signed by 91 Democratic members of the House of Representatives that was sent to the Biden administration on Monday, including a two-pronged request for cracking down on health plan noncompliance. The letter, led by Democratic Women’s Caucus chair Lois Frankel and first obtained by The New Republic, asks for new guidance clarifying that insurers must cover all prescribed contraceptive products without therapeutic equivalents, as well as the out-of-pocket costs for certain over-the-counter products. Despite updated guidance and enforcement from the Departments of Health and Human Services, Treasury, and Labor—or the tri-agencies, as they are known—the letter says that ‘unlawful barriers’ remain to accessing contraceptive care… citing an October report by the House Committee on Oversight and Reform… That report found that at least 34 contraceptive products face coverage exclusions or cost-sharing; for 12 of those products, there is no therapeutic equivalent. The October report also found that an average of 40 percent of exception requests were denied by insurers and pharmacy benefit managers between 2015 and 2021. The letter argues that if insurers haven’t changed their practice over the past decade or so, they aren’t going to start now if they’re left to their own devices.” [The New Republic, 3/28/23]

The Washington Post: Syphilis Cases are Increasing in Infants Across the Country. “A decade ago, the United States stood on the brink of eliminating the scourge of babies born with syphilis. Now, cases are surging, a phenomenon that is underscoring deep inequities in the nation’s health-care system and reviving concerns about a disease easily controlled with routine antibiotics. The spike, driven in part by the nation’s drug and homelessness crisis, is especially apparent across the Sun Belt, according to public health experts and data from the Centers for Disease Control and Prevention. The rate of syphilis is five times higher for babies born to Black mothers than to White mothers, reflecting racial disparities in access to maternal health care. While the overall number of infected infants seems low — nearly 2,700 nationally in 2021, or 74 of every 100,000 live births — public health officials say no baby in developed nations should be born with syphilis because most cases are preventable with testing and penicillin treatment of the mother. The fact that cases have climbed, experts say, is an indictment of the U.S. health-care system. Oman, Cuba and Sri Lanka are among the countries that have virtually eliminated mother-to-child transmission of syphilis in recent years, according to the World Health Organization. After steadily declining since World War II, congenital syphilis roared back in the United States to about 4,000 cases a year in the early 1990s as syphilis surged in adults. The number of infected infants dwindled to several hundred a year in the 2000s, then started climbing again in 2013. To reverse the trends, public health authorities are striving to reach women at highest risk for passing syphilis to their babies — those who are homeless, exchange sex for money, or use drugs are more likely to be exposed to the disease and less likely to seek prenatal care.” [The Washington Post, 4/1/23]

Yale Daily News: Researchers Predict Rapid Increase in HIV Infections Due Directly to Braidwood Ruling. “In a recent study led by the Yale School of Public Health, researchers found that the Sept. 2022 Texas ruling in Braidwood Management v. Becerra could potentially result in more than 2,000 predictable cases of human immunodeficiency virus in the U.S. in the coming year. In the study, the researchers tried to estimate how many new HIV infections would result from the outcome of this court ruling, focusing on men who have sex with men… In addition, the researchers estimated that coverage would drop from 28 percent to 10 percent after the Braidwood Management v. Becerra decision… However, according to Paltiel, this number is almost certainly an underestimate.” [Yale Daily News, 3/31/23]

Axios: The COVID-19 Pandemic Has Increased Maternal Mortality Rates. “The U.S. maternal mortality rate increased during the COVID-19 pandemic, disproportionately impacting Black women, with far higher odds of severe complications among pregnant patients with COVID infection at delivery, a new analysis published in JAMA Network Open found. The JAMA analysis, led by researchers from the University of Southern California, Los Angeles, found the mortality risk of pregnant patients with COVID-19 at delivery between March 2020 and December 2020 was 14 times higher than those without the virus. Previous studies have found contributors to the high maternal mortality rate during the pandemic have included a lag in COVID-19 vaccination in pregnant people due to concerns over the potential effects of the vaccine that may persist despite studies showing they are safe. The CDC estimates that as of April 1, approximately 71% of pregnant people have completed the primary vaccination series (below the vaccination rate for those over the age of 18), and only about 23% of pregnant people have received an updated booster dose. The pandemic also exacerbated existing social determinants of health, and as a result disproportionately impacted women of color, who were often on the frontlines working ‘essential’ jobs and getting sick.” [Axios, 4/10/23]

The Washington Post: Two Pregnant Women Were Denied Care After Florida Banned Abortion, One Almost Died. “[Anya Cook] was about to deliver her baby alone in the bathroom of a hair salon. On this Thursday afternoon in mid-December, about five months before her due date, she knew the baby would not be born alive. Over the course of the day, according to medical records, Cook would lose roughly half the blood in her body. She had intended to deliver the fetus in a hospital, a doctor by her side. When her water broke the night before — at least six weeks ahead of when a fetus could survive on its own — she drove straight to the emergency room, where she said the doctor explained that she was experiencing pre-viability preterm prelabor rupture of the membranes (PPROM), which occurs in less than 1 percent of pregnancies. The condition can cause significant complications, including infection and hemorrhage, that can threaten the health or life of the mother, according to multiple studies. At the hospital in Coral Springs, Fla., Cook received antibiotics, records show. Then she was sent home to wait. Cook’s experience reflects a new reality playing out in hospitals in antiabortion states across the country — where because of newly enacted abortion bans, people with potentially life-threatening pregnancy complications are being denied care that was readily available before the Supreme Court overturned Roe v. Wade in June. When abortion was legal across the country, doctors in all states would typically offer to induce or perform a surgical procedure to end the pregnancy when faced with a pre-viability PPROM case. But in the 18 states where abortion is now banned before fetal viability, many hospitals have been turning away pre-viability PPROM patients as doctors and administrators fear the legal risk that could come with terminating even a pregnancy that could jeopardize the mother’s well-being, according to 12 physicians practicing in antiabortion states. The medical exceptions to protect the life of the mother that are included in abortion bans are often described in vague language that does not appear to cover pre-viability PPROM, doctors said. A 2022 study on the impact of Texas’s six-week abortion ban found that 57 percent of pre-viability PPROM patients in Texas who were not given the option to end their pregnancies experienced ‘a serious maternal morbidity,’ such as infection or hemorrhage, compared with 33 percent of PPROM patients who chose to terminate in states without abortion bans.” [The Washington Post, 4/10/23]

***MEDIA ADVISORY FOR WEDNESDAY, APRIL 12 AT 11:00 AM AZ TIME // 2PM ET***

Congress is Fighting to Finish the Job of the Inflation Reduction Act by Extending the Insulin Copay Cap to all Diabetics

Phoenix, AZ — On Wednesday, April 12 at 11:00 AM AZ TIME, Rep. Ruben Gallego (AZ-03) will join Protect Our Care Arizona to discuss the ongoing efforts to expand the Inflation Reduction Act’s insulin savings to every Arizonan. The event will showcase the Inflation Reduction Act’s insulin cap that benefits more than three million seniors nationwide, including 63,185 Arizonans. Lowering insulin costs is especially important for people of color, who disproportionately suffer from diabetes and are more likely to skip, ration, or completely forgo insulin as a result of outrageous costs. Read more about how the lifesaving policy is helping Arizonans here. 

Now, Congress is fighting to extend these savings to all Arizonans and people across the country. This would be a key step to ensuring access to the medicine an estimated 21 million patients need to thrive.

WHO:
U.S. Representative Ruben Gallego, (AZ-03)
Dora Vasquez, Executive Director, Arizona Alliance for Retired Americans
Mary Lynn Kasunic, President & CEO, Area Agency on Aging
Valle del Sol Community Health Center
Protect Our Care Arizona

WHAT: Press Conference

WHERE: Valle del Sol Community Health Center, 3807 N. 7th St., Phoenix, AZ 85014
Watch the livestream here.

WHEN: Wednesday, April 12 at 11:00 AM AZ TIME // 2PM ET

President Biden Continues to Fight to Protect Free Preventive Care for 150 Million Americans

Washington, DC — Today, the Department of Justice announced it was seeking a stay of the devastating ruling in Braidwood Management v. Becerra, which ends a major provision of the Affordable Care Act (ACA) that requires no-cost coverage of lifesaving preventive health care services. Braidwood is the latest effort by ACA opponents and their Republican allies to dismantle American health care. As it stands, Judge O’Connor’s ruling applies nationwide and ends the benefits covered under the U.S. Preventive Services Task Force, including lifesaving colorectal and other cancer screenings, anxiety and depression screenings for children and adults, heart disease screenings, and access to PrEP (pre-exposure prophylaxis), which can substantially reduce the chance of contracting HIV. Read more about the case here. 

In response, Protect Our Care Chair Leslie Dach issued the following statement: 

“Braidwood is a politically-driven effort to dismantle the ACA, brought by longtime foes of abortion rights, women’s health, LGBTQI+ rights, and affordable health care. Now, the same judge who ruled that the ACA should be overturned entirely is ending lifesaving protections under the health care law that 150 million Americans rely on. If Judge O’Connor’s ruling stands, more people will get sick, more people will die, and more people will have to choose between paying for health care and food or rent. The harm that will be caused by denying over 150 million people preventive health care is clear and irreparable. The court should act quickly to stay Judge O’Connor’s life-threatening decision.”

Watch the Event Here. 

Washington, DC – Today, Democratic Women’s Caucus Communications Task Force Co-Chairs Rep. Gwen Moore (D-WI-04) and Rep. Shontel Brown (D-OH-11) and President of the National Partnership for Women & Families Jocelyn Frye joined Protect Our Care for a press conference to discuss the ways Medicaid is a lifeline for women and children across the nation. 

During the call, speakers discussed how Republicans in Congress are seeking deep cuts to Medicaid and proposing bureaucratic work reporting requirements. GOP leaders in 10 states have still failed to expand Medicaid under the Affordable Care Act, blocking millions of families from affordable coverage. Meanwhile, protections put into place by Congress to keep people enrolled in Medicaid during the pandemic expired on April 1. It is predicted that approximately 15 million people may lose their coverage due to the unwinding with those in non-expansion states being particularly vulnerable. 

April marks the 5th annual Medicaid Awareness Month. A record 92 million Americans have enrolled in Medicaid. Adult women comprise an estimated 40 percent of those enrolled in Medicaid, and over half (54 percent) of children across the country are enrolled in Medicaid/CHIP. Read Protect Our Care’s fact sheet on how Medicaid helps women and children here. 

“I’m proud to serve as Chair of the Democratic Women’s Caucus and what we do is pretty simple: we fight with everything we’ve got for women and families. Women want their families and their kids to be healthy, plain and simple—and that means protecting Medicaid,” said Democratic Women’s Caucus Chair Lois Frankel (D-FL-22). “With Republicans in Congress seeking serious cuts to Medicaid that would be devastating for women, we’re fighting to protect and strengthen Medicaid for years to come. We’re fighting to make sure women can make their own health care decisions—without political interference. And the Democratic Women’s Caucus doesn’t back down.”

“As Republicans propose cruel and unnecessary work requirements for Medicaid, it’s so important that we stand up for this critical program and the millions of Americans it serves,” said U.S. Representative Gwen Moore (D-WI-04), Democratic Women’s Caucus Communications Task Force Co-Chair. “I am proud to join my colleagues and advocates in these efforts today and will continue championing Medicaid.”

“Medicaid is a crucial component to the health and welfare of women and children across the country,” said U.S. Representative Shontel Brown (D-OH-11), Democratic Women’s Caucus Communications Task Force Co-Chair. “Women of color consistently experience higher maternal mortality rates than white women primarily due to the intersection of multiple socio-economic factors, including generations of health inequities, and quite simply, institutional and structural racism. Expanding Medicaid and closing the coverage gap is a key element to improving maternal and reproductive health, especially for women of color.”

“As America’s crisis in maternal health worsens with each year, the importance of defending and expanding Medicaid is more urgent than ever,” said Jocelyn Frye, President of the National Partnership for Women & Families. “Medicaid is the largest source of reproductive health care in our country and strengthening its services is a key solution for addressing the maternal health crisis—which is especially severe among Black and Indigenous women.  With reproductive freedom currently under attack throughout our nation, the National Partnership is proud to mark Medicaid Awareness Month by calling on policymakers at every level to make Medicaid available to every household who needs it.”  

“When I was a college student at Lehigh University, I became ill in the winter of 2005. My illness dragged on and we didn’t really find a clear diagnosis for about eight to 10 years,” said Kristin Volchansky, patient storyteller from Pennsylvania. “The great thing about the Medicaid program is that it has protected my rights as a patient with an illness. I echo the concerns about work requirements. Work requirements are something that I know personally after attempting to try to work part time when I was improving a couple of years ago. With the wages that I would have earned, there would have been a severe reduction in my benefits, or I would have been completely removed from the program.” 

“Medicaid provides people from all backgrounds affordable, quality coverage, and it is absolutely vital for promoting maternal and child health,” said Protect Our Care Communications Director Anne Shoup. “We must continue to fight Republican attempts to undermine the program and work to expand Medicaid in the final 10 states to ensure women and their children can get the care they need and stay healthy.” 

Washington, DC – Last week, a federal judge in Texas issued a ruling revoking authorization for mifepristone, a safe and effective medication essential for abortion access 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 opens the door for the politically-motivated removal of other safe and effective drugs from the market — throwing the entire U.S. drug approval process into chaos. Fierce opposition to the ruling has quickly emerged, with leaders in public health, former FDA and HHS officials, experts in the FDA, patient voices, and more than 400 top drug and biotechnology industry executives condemning the ruling. Read Protect Our Care’s new report on the case here. 

HEADLINES

New York Times: Drug Company Leaders Condemn Ruling Invalidating F.D.A. Approval of Abortion Pill. “The pharmaceutical industry plunged into a legal showdown over the abortion pill mifepristone on Monday, issuing a scorching condemnation of a ruling by a federal judge that invalidated the Food and Drug Administration’s approval of the drug and calling for the decision to be reversed. The statement was signed by more than 400 leaders of some of the drug and biotech industry’s most prominent investment firms and companies, none of which make mifepristone, the first pill in the two-drug medication abortion regimen. It shows that the reach of this case stretches far beyond abortion. Unlike Roe v. Wade and other past landmark abortion lawsuits, this one could challenge the foundation of the regulatory system for all medicines in the United States. ‘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,’ said the statement.” [New York Times, 4/10/23]

The Hill: Drug Companies Slam Texas Judge’s Ruling On Abortion Pill. “Drug industry experts, current and former administration officials and abortion rights advocates have been sounding the alarm that U.S. District Court Judge Matthew Kacsmaryk’s ruling in favor of anti-abortion groups would have far-reaching consequences for FDA’s authority. The decision ‘undermines our nation’s entire system of drug approval. It opens the door for courts to overturn FDA’s evidence-based decisions for purely political or ideological reasons,’ Health and Human Services Secretary Xavier Becerra said in a statement Friday after the ruling. If the decision is upheld, it could open the door to any third party to challenge any medication or treatment that they disagree with, including vaccines for children, AIDS drugs, birth control or hormone therapy. […] William Schultz, a partner at Zuckerman Spaeder and former FDA deputy commissioner, told reporters during a briefing Monday that the ruling adds another barrier for bringing drugs and treatments to the market. ‘In order to get a drug approved, companies will not just have to survive literally often hundreds of millions of dollars and years of testing [and] FDA scientific review, but then they’ll have to survive challenges in court, which could be immediate, or as in this case, 20 years later, Schultz said.” [The Hill, 4/10/23]

The Washington Post: Justice Department Appeals Texas Abortion Pill Ruling. “The Justice Department on Monday appealed a Texas judge’s decision that would block access to a key abortion drug across the country, arguing that the challengers had no right to file the lawsuit since they were not personally harmed by the abortion pill. The 49-page appeal, filed in the right-leaning U.S. Court of Appeals for the 5th Circuit, landed less than one business day after Judge Matthew J. Kacsmaryk suspended Federal Drug Administration approval of mifepristone — one of the two medications used in more than half of all abortions in the United States. […] The judge’s ruling, Justice Department lawyers said, ‘upended decades of reliance by blocking FDA’s approval of mifepristone and depriving patients of access to this safe and effective treatment, based on the court’s own misguided assessment of the drug’s safety.’” [The Washington Post, 4/10/23]

Talking Points Memo: Upholding Kacsmaryk’s Decision Would Invite Challenges To Vaccines, Contraception. “These problems with the case make it an enormous risk — even beyond making mifepristone unavailable for the millions who need it — should Kacsmaryk’s ruling be upheld. It could fling wide the floodgates to those seeking to challenge the FDA’s approval in an attempt to get certain drugs removed from the market. This danger could also prove mifepristone’s salvation: Even a fundamentally anti-abortion Supreme Court majority might be less inclined to uphold Kacsmaryk’s decision, given the severity of the ramifications. ‘Allowing the courts to do this, to do this kind of searching inquiry and overturn FDA if the judge thinks FDA was wrong in combination with the court’s ruling on standing…could allow virtually anyone to challenge any FDA drug approval decision with a good chance at succeeding,’ William Schultz, former deputy FDA commissioner and HHS General Counsel, told reporters Monday.” [Talking Points Memo, 4/11/23]

New York Times (Opinion): I Worked at the F.D.A. The Abortion Pill Decision Is Dangerous. “A federal judge in Texas has taken a shocking and irresponsible action: invalidating the Food and Drug Administration’s approval of mifepristone, a medication used safely by hundreds of thousands of women each year to help terminate pregnancies as part of a two-pill regimen. For what appears to be the first time, a court has invalidated an agency drug approval — an approval that was based on extensive review of scientific evidence, earned the unanimous support of outside experts and retains, after two decades, the full backing of major professional medical organizations. The decision is so stunning that it is reasonable to ask whether courts should have any role in reviewing the F.D.A.’s scientific decision-making at all. In fact, judges do have an important job: protecting the ability of the agency to use science and expert judgment to support the health of the American people. The Texas decision is a perversion of this role and, by undermining the F.D.A., represents a threat to the safety of millions of Americans.” [New York Times (Opinion), 4/10/23]

Washington Post: Texas Abortion Pill Ruling Threatens FDA. “Friday’s dueling decisions over a key abortion drug thrust the Food and Drug Administration into an unprecedented legal bind, imperiling its authority to approve and regulate medications, legal scholars said. In Washington state, a federal judge ruled Friday that mifepristone is safe and effective, ordering the FDA to preserve access to the pill in the 17 states and D.C. that sued to protect medication abortion. But in Texas, another federal judge sided with antiabortion groups to block the agency’s approval of mifepristone, a decision that won’t go into effect for seven days, to give the federal government a chance to appeal. ‘It is totally unclear how FDA is supposed to resolve this because this isn’t the way FDA does its job,’ said Kirsten Moore, director of the advocacy organization Expanding Medication Abortion Access Project. ‘It shouldn’t have to say in these states the drug is approved, in these states the drug isn’t approved. That’s not tenable.’” [Washington Post, 4/7/23]

Politico: The Abortion Pill Rulings Are Scaring The FDA and Drugmakers. Here’s Why. “A Texas judge’s decision to rescind the FDA’s approval of the abortion pill could jeopardize access to the most popular method of terminating a pregnancy. And many in government and inside the pharmaceutical industry fear that it could also undermine the agency’s broader authority to regulate medicines, opening the door for courts to question approvals of anything from birth control pills to new treatments for debilitating diseases. […] William Schultz, former deputy commissioner for the FDA and former general counsel for HHS, said the decision ‘could allow virtually anyone to challenge any FDA drug approval decision with a good chance of succeeding.’ ‘Any FDA drug approval involves hundreds of judgments by the agency. If a court feels free just to kind of take a fresh look at each of those, there’s a chance that a court will find one of those judgments is wrong,’ Schultz said. HHS did not immediately respond to a request for comment on Monday.” [Politico, 4/10/23]

New York Times: Why Drugmakers’ Battle in Texas is Such a Big Deal. “The decision by a judge in Texas to overturn F.D.A. approval for the abortion pill mifepristone could have consequences far beyond the fraught area of reproductive health, throwing the regulatory regime for medicines into disarray and potentially upending the business of drug making. The ruling to reverse a green light given more than 20 years ago has sparked a furious response from pharmaceutical executives, and the Biden administration is pushing for the decision to be blocked. More than 400 pharmaceutical and biotech industry leaders slammed the ruling. ‘Judicial activism will not stop here,’ they warned in an open letter on Monday, after Matthew Kacsmaryk, a federal court judge, sided with anti-abortion groups who challenged the F.D.A. approval of mifepristone over ‘safety concerns.’ Medical organizations such as the American Medical Association and the American College of Obstetricians and Gynecologists say the drug is safe, and the pharmaceutical executives called for ‘the decision to disregard science’ to be reversed. The Justice Department said Mr. Kacsmaryk’s findings were incorrect and that he had engaged in an ‘extraordinary and unprecedented’ effort to usurp the F.D.A.’s authority. Retrospectively overturning F.D.A. decisions that are based on years of testing could also destabilize the industry. Dr. Jeremy Levin, C.E.O. of Ovid Therapeutics and the former chairman of BIO, a biotech trade association, told The Times that the ruling opened the door to ‘a political determination of what a medicine is and isn’t.’ The precedent could be ‘deeply harmful for vaccines, Alzheimer’s drugs, all the others,’ he added.” [New York Times, 4/11/23]