News

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]

Watch the Event Here. 

Washington, DC — Today, Former Deputy FDA Commissioner and HHS General Counsel Williams Schultz and Dean of GWU’s Milken Institute School of Public Health Lynn Goldman joined Supreme Court and appellate lawyer Andy Pincus and Protect Our Care to discuss the disastrous implications of Judge Matthew Kacsmaryk’s ruling to invalidate the FDA’s approval of mifepristone. During the event, speakers discussed how Judge Kacysmaryk’s ruling has wider implications for the health care system and sets a precedent for any judge to be able to overrule the evidence-based and scientific FDA medication approval process. Read Protect Our Care’s new report on the case here. 

“In this case where the drug has been in use for decades, the harm to tens if not hundreds of thousands of women from removing its availability would be very significant,” said Andrew Pincus, Visiting Lecturer in Law at Yale Law School and experienced Supreme Court and appellate lawyer. “If this decision stands, then any group of doctors who are opposed to a particular drug or vaccine could bring a similar lawsuit, and that will really open the door to very broad instability in the drug approval process.” 

“Congress in the statute directed the FDA to evaluate the safety and effectiveness of drugs to determine whether the benefits of the drug outweigh the risks. This is a complex decision involving medicine, statistics, and sometimes epidemiology,” said William Schultz, Partner, Zuckerman Spaeder, former Deputy Commissioner, FDA, former General Counsel, Department of Health and Human Services. “If the decision were upheld, it could have a devastating effect on drug and vaccine development in this country. It would mean that in order to get a drug approved, companies will not just have to survive 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.” 

“For doctors or patients and their families, it is critically important that we can trust the basis for the approval of a drug,” said Lynn R Goldman, MD, MS, MPH, Professor and Dean, Milken Institute School of Public Health, George Washington University. “There are reams of data that underlie every drug approval process and a multitude of decisions that must be made. For us to trust the consequences of that review, they need to be made by scientific experts who understand those data and can best evaluate them —  and those experts are not judges and they’re not courts of law.” 

“Judge Kacysmaryk’s ruling threatens to throw the entire U.S. drug approval process into chaos,” said Protect Our Care Chair Leslie Dach. “It not only puts at risk the use of mifepristone for safe and legal abortions, but it opens the door for the politically-motivated removal of other safe and effective drugs from the market. If the ruling stands, millions of patients will suffer.”

***MEDIA ADVISORY FOR MONDAY APRIL 10 AT 2:30 PM ET***

Devastating Ruling Threatens Essential Reproductive Care and Entire U.S. Drug Approval Process

Washington, DC — On Monday, April 10, 2023 at 2:30 PM ET, Williams Schultz, former deputy FDA commissioner and HHS General Counsel, Lynn Goldman, Dean of the Milken Institute School of Public Health at George Washington University, and experienced Supreme Court and appellate lawyer Andy Pincus will join Protect Our Care to discuss the disastrous implications of Judge Matthew Kacsmaryk’s ruling to invalidate the FDA’s approval of mifepristone. Judge Kacysmaryk’s ruling puts at risk not only 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.

During the call, speakers will discuss how the Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration lawsuit has wider implications for the health care system and sets a precedent for any judge to be able to overrule the evidence-based and scientific FDA medication approval process.

PRESS CALL:

WHO:
William Schultz, Partner, Zuckerman Spaeder, former Deputy Commissioner, FDA, former General Counsel, Department of Health and Human Services
Lynn R Goldman, MD, MS, MPH, Professor and Dean, Milken Institute School of Public Health, George Washington University
Andrew Pincus, Visiting Lecturer in Law at Yale Law School and experienced Supreme Court and appellate lawyer
Leslie Dach, Chair of Protect Our Care

WHAT: Virtual Press Conference 

WHERE: Register for the Event Here

WHEN: April 10, 2023 at 2:30 PM ET

Devastating Ruling Threatens Access to Essential Reproductive Care and Entire U.S. Drug Approval Process

Washington DC — Today, Judge Matthew Kacsmaryk issued a ruling to pull mifepristone from the market. Mifepristone is a safe and effective medication that is essential to abortion access across the nation. This decision not only threatens access to vital reproductive care for millions of women, but it opens the door for the politically-motivated destruction of the entire drug approval process. In response, Protect Our Care Chair Leslie Dach issued the following statement:

“Today’s decision is a disaster for the American people. We are talking about a right-wing judge overruling the opinion of top scientists and other medical experts at the FDA. Taking away a safe, effective medication for abortion is dangerous, especially for rural women, people of color, and other vulnerable groups. This decision also means that judges now have the power to rip away other medications at the whim of their political motivations. This ruling must not stand.”

***MEDIA ADVISORY FOR THURSDAY, APRIL 6***

During Medicaid Awareness Month, Republicans’ Latest Attack on the ACA Targets Lifesaving Preventive Care for More than 150 Million Americans 

On Thursday, April 6th, U.S. Representative Jimmy Gomez, California Attorney General Rob Bonta, New York elected officials, and health care advocates will join Protect Our Care in California and New York to discuss U.S. District Judge Reed O’Connor’s devastating decision to strike down a major provision of the Affordable Care Act (ACA) that requires free coverage of lifesaving preventive health care services. During the call, speakers will highlight what this decision could mean for Americans’ access to lifesaving health care services, and discuss what is to come as the lawsuit moves through the court system.

Judge O’Connor’s decision in Braidwood Management v. Becerra would end the ACA’s guaranteed free access to essential preventive services including lifesaving cancer screenings, anxiety and depression screenings for children and adults, heart disease screenings, intimate partner violence screenings, and access to PrEP (pre-exposure prophylaxis), which can reduce the chance of contracting HIV. In 2020 alone, more than 150 million Americans benefited from these preventive services. Read more about the case here. 

The decision comes as Medicaid Awareness Month kicks off with groups across the country highlighting Republican threats to the program, including plans to slash funding, endangering care for millions of seniors, families, and children who rely on the program for coverage.

CALIFORNIA
WHO:
U.S. Representative Jimmy Gomez
California Attorney General Rob Bonta

WHEN: Thursday, April 6, 10 AM PT // 1 PM ET

WHERE: Register to join the Zoom event (Registration required)

NEW YORK
WHO:
Brad Hoylman, New York State Senator, 47th District
Erik Bottcher, New York City Council Member, 3rd District
Peter Meacher, Chief Medical Officer, Callen-Lorde Community Health Center
Jason Cianciotto, Vice President of Communications & Policy at Gay Men’s Health Crisis
Amanda Babine, Executive Director of Equality New York
Dr. Archie Jao, Medical Director at Housing Works
Paul Nagle, Executive Director of Stonewall Community Development Corporation

WHEN: Thursday, April 6 at 1:30 PM ET 

WHERE: Register to join the Zoom event (Registration required)