U.S. Sen. Tammy Baldwin
Press Release

Baldwin Joins 240 Members of Congress in Urging Appeals Court to Prevent Dangerous Ruling Threatening Access to Mifepristone From Taking Effect

240 Members of Congress ask Fifth Circuit to stay district court ruling that threatens access to mifepristone nationwide—and access to all manner of other FDA-approved drugs

By - Apr 14th, 2023 08:35 am

WASHINGTON, D.C. – Senator Tammy Baldwin (D-WI) joined 240 Members of Congress in submitting an amicus brief to the U.S. Court of Appeals for the Fifth Circuit in the case of Alliance for Hippocratic Medicine v. FDA, in support of the Biden administration’s appeal of federal district court judge Matthew J. Kacsmaryk’s ruling that suspends the Food and Drug Administration’s (FDA) more than 20-year-old approval of mifepristone—threatening access to mifepristone for patients nationwide, as well as FDA’s Congressionally-mandated authority and drug approval process. The amicus brief comes as the Biden administration asked the Supreme Court to intervene to stop restrictions set by Kacsmaryk’s decision.

In the new amicus brief, the Members of Congress underscore that the district court ruling has no basis in law, risks denying patients in every part of the country access to mifepristone, a safe and effective medication widely used in abortion care and miscarriage management for years, and jeopardizes patients’ access to a wide array of other medications by threatening FDA’s drug approval process, which was designed and mandated by Congress. Accordingly, they ask the court to stay the district court’s order.

“The district court appears to have second-guessed FDA’s scientific determinations with cherry-picked anecdotes and studies, and on that basis, imposed a remedy that could significantly upend the status quo,” write the lawmakers in their brief.

If the district court ruling were left to stand and were to go into effect, the Members stress that not only could patients in every state be denied access to the most common form of abortion care—and a key drug used in miscarriage management—but FDA’s authority to determine the safety and efficacy of other drugs would be put at risk, threatening patients’ access to all manner of other medications.

“[T]he district court’s misguided stay under Section 705 of the Administrative Procedure Act will reduce access to abortion, exacerbating an already significant reproductive health crisis,” write the lawmakers, adding: “The consequences of the district court’s remedy could extend far beyond mifepristone, for it undermines the science-based, expert-driven process that Congress designed for determining whether drugs are safe and effective.”

“Its perilous consequences reach far beyond mifepristone. Providers and patients rely on the availability of thousands of FDA-approved drugs to treat or manage a range of medical conditions, including asthma, HIV, infertility, heart disease, diabetes, and more,” the lawmakers state.

The Members also explain that Congress specifically designed FDA’s expert-driven drug approval process to ensure that the medications relied on by Americans every day are safe and effective. FDA followed that careful review process before it approved mifepristone for use in 2000, and its approval has been repeatedly affirmed in the more than 20 years since.

“For the last century, a statutory scheme designed by Congress has assured the safety and effectiveness of the drugs available in the United States. At its core resides the application of scientific standards by agency experts,” the lawmakers write. “Here, FDA’s determination that mifepristone is safe and effective is based on a thorough and comprehensive review process prescribed and overseen by the legislative branch. Since mifepristone’s initial approval in 2000, FDA has repeatedly and consistently reaffirmed that the medication is safe and effective for its approved conditions of use. FDA’s process and conclusions have been validated by both Congress and the Government Accountability Office—and by the lived experience of over 5 million patients who have used the drug in the United States.”

The lawmakers conclude by asking the Fifth Circuit to stay the decision, writing: “emergency relief from the order is necessary to mitigate the imminent harm facing members of the public, many of whom rely on the availability of mifepristone for reproductive care—and many more of whom rely on the integrity of FDA’s drug approval process for continued access to life-improving and lifesaving drugs. Congress intended to—and did—vest authority in FDA to evaluate and ensure the safety and efficacy of drugs in the United States, and Amici call on this Court to give due weight to that intent.”

In the Senate, the amicus brief was signed by 50 Senators: Senators Schumer, Murray, Sanders, Durbin, Blumenthal, Baldwin, Bennet, Booker, Brown, Cantwell, Cardin, Carper, Casey Jr., Coons, Cortez Masto, Duckworth, Feinstein, Fetterman, Gillibrand, Hassan, Heinrich, Hickenlooper, Hirono, Kaine, Kelly, King, Klobuchar, Luján, Markey, Menendez, Merkley, Murphy, Ossoff, Padilla, Peters, Reed, Rosen, Schatz, Shaheen, Sinema, Smith, Stabenow, Tester, Van Hollen, Warner, Warnock, Warren, Welch, Whitehouse, Wyden.

In the House, the brief was signed by 190 Representatives: Representatives Jeffries, Clark, Pallone, Nadler, DeGette, Barbara Lee, Adams, Allred, Aguilar, Auchincloss, Balint, Barragán, Beatty, Bera, Beyer, Bishop, Blumenauer, Blunt Rochester, Bonamici, Bowman, Boyle, Brown, Brownley, Budzinski, Bush, Caraveo, Carbajal, Cárdenas, Carter, Cartwright, Casar, Case, Casten, Castor, Castro, Cherfilus-McCormick, Chu, Cicilline, Clarke, Cleaver, Clyburn, Cohen, Connolly, Courtney, Craig, Crockett, Crow, Davids, Davis, Dean, DeLauro, DelBene, Deluzio, DeSaulnier, Dingell, Doggett, Escobar, Eshoo, Espaillat, Evans, Fletcher, Foster, Foushee, Frankel, Frost, Gallego, Garamendi, R. Garcia, C. García, Gluesenkamp Perez, Goldman, Gomez, Gottheimer, Green, Grijalva, Higgins, Himes, Holmes Norton, Horsford, Houlahan, Hoyer, Hoyle, Huffman, Ivey, Jackson Lee, Jacobs, Jayapal, Johnson, Kamlager-Dove, Kaptur, Kelly, Khanna, Kildee, Kilmer, Kim, Krishnamoorthi, Kuster, Landsman, Larson, Susie Lee, Summer Lee, Leger Fernandez, Levin, Lieu, Lofgren, Lynch, Magaziner, Manning, Matsui, McClellan, McCollum, McGovern, Meeks, Menendez, Meng, Moore, Morelle, Moskowitz, Mullin, Napolitano, Neal, Neguse, Nickel, Norcross, Ocasio-Cortez, Omar, Panetta, Pappas, Pascrell, Payne, Pelosi, Peltola, Peters, Pettersen, Phillips, Pingree, Pocan, Porter, Pressley, Quigley, Raskin, Ross, Ruiz, Ruppersberger, Ryan, Sablan, Salinas, Sánchez, Sarbanes, Scanlon, Schakowsky, Schiff, Scholten, Schrier, Bobby Scott, Sewell, Sherman, Sherrill, Slotkin, Smith, Sorensen, Soto, Spanberger, Stansbury, Stanton, Stevens, Strickland, Swalwell, Sykes, Takano, Thompson, Titus, Tlaib, Tokuda, Tonko, Ritchie Torres, Norma Torres, Trahan, Trone, Underwood, Vasquez, Veasey, Velázquez, Wasserman Schultz, Waters, Watson Coleman, Wexton, Wild, Williams, Wilson.

The lawmakers’ amicus brief can be read in full here.

An online version of this release is available here.

NOTE: This press release was submitted to Urban Milwaukee and was not written by an Urban Milwaukee writer. While it is believed to be reliable, Urban Milwaukee does not guarantee its accuracy or completeness.

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Comments

  1. robertm60a3 says:

    What has Senator Baldwin done to hold anyone in government accountable for failure? Has anyone been fired? Are any promotions on hold?

    Does she listen to the people that she is supposed to represent? Or, does she hire a few professional staffers without any background and just go through the motions?

    What has she actually done? What about the loss in Afghanistan, billions spent making private companies rich running military housing. Not one is held accountable for waste and poor leadership.

    Again, what has the Senator done?

  2. gwarzyn says:

    Perhaps you are mixing her up with Ron Johnson

  3. robertm60a3 says:

    No. However, I agree – I can’t think of anything Ron Johnson has done to hold anyone accountable. There was a Senate hearing on military housing – then nothing, and both Senator Johnson and Baldwin voted to approve the promotion of one of the individuals responsible.

    Believe that part of the problem is the media publishing news releases and not asking hard questions. But, . . .

    I sent a letter to both Senator Baldwin and Johnson with a draft letter to the Secretary of the Navy and nothing. . . Following is the letter that I ask to be sent to the Secretary of the Navy – nothing. . . . I could go on with other examples.

    United States Senate
    Washington, DC

    Honorable Carlos Del Toro
    Secretary of the Navy
    1000 Navy Pentagon,
    Washington, DC 20350

    A constituent recently brought to my attention a series of Secretarial letters of Censure signed by the former Secretary of the Navy Richard V. Spencer. These letters document behavior that was a discredit to the proud history of the United States Navy and less than what should be expected by the citizens of the United States and those serving in the military.
    My constitution has asked for information on the handling of these cases and what consideration, if any, was given considering the authority granted to the Secretary of the Navy under the provisions of 10 U.S. Code § 1370 Retirement of Regular Commissioned Officers in the Highest Grade in Which Served Satisfactorily. The law provides that where an officer has committed misconduct, the Secretary of the Navy may deem the officer to have not served satisfactorily, and the grade next lower shall be the retired grade of the officer.
    Effective January 1, 2021, Subsection (f) of § 1370 provides the Secretary of the Navy with the authority to reopen a retirement grade determination “If substantial evidence comes to light after the retirement that could have led to the determination of a different retired grade if known by competent authority at the time of retirement.”
    While I understand that the final decision is your, this authority would allow you to review the following cases where the behavior was less than the high standards of the U.S. Navy and where justified, as authorized by law (10 U.S. Code § 1370(f)(6)), administratively reduce the retired rank to the next lower level.
    The following is a list of officers, the date of the Secretarial Letter of Censure, with quotes from the Letter of Censure:
    a. Rear Admiral (Upper Half) Mark C. Montgomery, USN (Ret), from Censure dated November 19, 2018
    “. . . demonstrated exceedingly poor judgment and leadership by repeatedly and improperly accepting gifts . . . improperly endorsed, provided information to, . . . made false official statements to mislead . . . you also committed the offense of graft, . . . brought discredit upon the Navy. . . “
    b. Rear Admiral (Upper Half) Richard Wren, USN (Ret), from Censure dated June 14, 2018
    “. . . demonstrated exceedingly poor judgment and leadership by repeatedly and improperly accepting gifts . . .you lied and misled the investigator rather than take responsibility for your actions. . . . brought ill-repute and disgrace upon our honored institution. . .led officers under your charge and your leadership to imitate your poor behavior.”
    c. Rear Admiral (Lower Half) Kenneth J. Norton, USN (Ret), from Censure dated November 28, 2017
    “. . . demonstrated exceedingly poor judgment and leadership by repeatedly and improperly accepting gifts. . . attended a private party . . . paid nothing . . . including services of prostitutes . . . you directed your subordinate officers to attend . . . approximately $9,000 on food, alcohol, and the services of prostitutes. . . . lead a reasonable person . . . to believe that you used your public office for private gain. . . provided the worst type of example for subordinate officers . . . deviation from the standards . . . disgrace . . .”
    d. Captain Timothy Conroy, USN (Ret), from Censure dated June 14, 2018
    “. . . demonstrated exceedingly poor judgment and leadership by repeatedly and improperly accepting gifts . . . These events involved excessive alcohol consumption and included the presence of women identified as prostitutes, . . . By encouraging subordinate officers to attend these events, . . . to identify and target other officers. . . It is clear that you did not care about the reputation of the Navy or the example you were setting for subordinate officers.”
    e. Captain Ricardo Martinez, USN (Ret), from Censure dated April 29, 2019
    “From February 2002 to July 2006, . . . you demonstrated exceedingly poor judgment and blatant disregard for principles of ethical conduct. . . . You also committed graft . . . Based on the evidence reviewed, the total value of the gifts you wrongfully received or solicited was $15,845.42. . . . you willfully derelict in your duties. . . .”
    The Sailors of the United States Navy deserve the best leadership available. Based on the behavior documents in the cited Letters of Censure (copies attached), my constitution believes that there was a failure in leadership. It is not in the security interest of the United States to reward those that fail our Sailors and bring discredit to the United States Navy.
    Please provide me with a written response so that I may provide my constitution concerning actions that you have taken or plan to take to reduce the rank of these officers in retirement.

    5 Enclosures Sincerely,
    Letters of Censure

    Ron Johnson
    Senator

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