Budzinski, Casten, Balint, Foushee, Tokuda Urge HHS and FDA to Ensure Patient Access to Methotrexate and Misoprostol

Nov 14, 2023
Health Care
Press

Washington, D.C. (November 14th, 2023)  Today, U.S. Representatives Nikki Budzinski (IL-13), Sean Casten (IL-06), Becca Balint (VT-AL), Valerie Foushee (NC-04) and Jill Tokuda (HI-02) led 48 of their colleagues in a letter to the U.S. Department of Health and Human Services, the HHS Office of Civil Rights, and the Federal Food and Drug Administration urging them to ensure access to methotrexate and misoprostol and urging the restoration of care for people across the country. 

“Since the Supreme Court’s Dobbs v. Jackson Women’s Health Organization decision in June 2022, people across the country have been denied access to methotrexate and misoprostol,” the lawmakers wrote. “In many states, physicians, other types of providers and pharmacists must comply with extreme and often confusing abortion bans and restrictions. These laws have created a chilling effect in which providers are fearful to offer medications like methotrexate and misoprostol to manage chronic conditions or for miscarriage management, because they could under another use be used for or cause an abortion. While we appreciate the statement on July 13, 2022, from the Department of Health and Human Services reminding retail pharmacies of their obligation to supply prescribed medications in a nondiscriminatory manner, this issue persists.”

Methotrexate is critical for patients to treat rheumatoid arthritis (RA), other autoimmune disorders, and some cancers, including breast cancer, lymphoma and leukemia, among other conditions. Misoprostol is used to prevent gastric ulcers and helps with managing miscarriages. 

The full text of the letter can be found here and below. 

Dear Secretary Becerra, Commissioner Califf, and Director Rainer,

Thank you for your leadership and collaboration in spurring adequate supply and nondiscriminatory distribution of critical medications. The dual threats of short supply and unintended chilling effects of abortion restrictions and bans have in some circumstances made accessing certain medications for chronic conditions and reproductive health particularly difficult, if those medications can also be used for or cause an abortion. We are reaching out today because these factors continue to hinder access to the medications methotrexate and misoprostol. 

Methotrexate is a commonly prescribed medication used to treat rheumatoid arthritis (RA), other autoimmune disorders, and some cancers, including breast cancer, lymphoma and leukemia, among other conditions. It is an antimetabolite which alleviates RA by reducing the activity of the immune system. It is Food and Drug Administration approved and often the first line of defense against RA, being used to treat inflammation which cannot be controlled by a biologic alone. Its injectable form is used to treat ectopic pregnancy. Misoprostol is a medication used to prevent gastric ulcers, for miscarriage management, and for abortion. 

Since the Supreme Court’s Dobbs v. Jackson Women’s Health Organization decision in June 2022, people across the country have been denied access to methotrexate and misoprostol. In many states, physicians, other types of providers, and pharmacists must comply with extreme and often confusing abortion bans and restrictions. These laws have created a chilling effect in which providers are fearful to offer medications like methotrexate and misoprostol to manage chronic conditions or for miscarriage management, because they could under another use be used for or cause an abortion. While we appreciate the statement on July 13, 2022, from the Department of Health and Human Services reminding retail pharmacies of their obligation to supply prescribed medications in a nondiscriminatory manner, this issue persists.

Further, the supply chain for methotrexate is at risk, and manufacturers have not kept up with demand. In Spring 2023, Akorn Pharmaceuticals, the largest manufacturer of generic methotrexate filed for Chapter 7 bankruptcy and closed. This has left a gap in the market, which has contributed to the shortage of the medication. 

Without access to this critical medication, people’s lives are at risk. In response to this shortage, we request answers to the following:

  • What steps are HHS and the FDA taking to strengthen the supply chain for methotrexate, and ensure an adequate supply of this medication?
  • What barriers to the manufacture and distribution of methotrexate remain?
  • What Congressional support or assistance do HHS and the FDA need to address these barriers and ensure adequate supply and distribution of methotrexate?
  • In addition to monitoring and enforcement actions, what proactive steps is the Office for Civil Rights taking to ensure that all pharmacy retailers are dispensing reproductive health medications and medications for chronic conditions, like methotrexate and misoprostol, in a nondiscriminatory manner? 

We request your prompt response to these questions and appreciate your collaboration in restoring access to care for people across the country. 

Sincerely,

###

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