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Rep. Carolyn Maloney Urges HHS to Streamline Access to Monkeypox Treatment TPOXX

Strategic Insights

— 2 min read

House Oversight and Reform Committee Chairwoman Rep. Carolyn Maloney (D-NY) issued a letter to the Department of Health and Human Services (HHS) on August 10, 2022, urging the agency to take all necessary steps to ensure patients can safely and easily access the antiviral medication TPOXX (tecovirimat) for the treatment of monkeypox. Maloney's letter comes as nearly 10,000 monkeypox cases have been reported across the United States, including nearly 3,000 cases reported in just the past week.

Maloney expressed concern that patients and health care providers are continuing to face hurdles accessing treatment, despite the Biden-Harris Administration's recent steps to address the outbreak. She emphasized that TPOXX has been highly effective in treating monkeypox, with lesions in several instances reportedly disappearing within days of initiating treatment. However, the current EA-IND protocols require physicians to submit their resumes and informed consent forms from all monkeypox patients to whom they intend to prescribe the drug, making it a burdensome and difficult process.

Key Takeaways:

  • Rep. Carolyn Maloney urged HHS to simplify the process for patients to access TPOXX, an antiviral medication used to treat monkeypox.
  • Nearly 10,000 monkeypox cases have been reported across the United States, with 3,000 cases reported in the past week alone.
  • TPOXX has been highly effective in treating monkeypox, with lesions reported to disappear within days of initiating treatment.
  • The current EA-IND protocols require physicians to submit extensive paperwork, including informed consent forms and resumes, making it difficult for patients to access the medication.
  • European regulatory agencies have authorized or approved TPOXX for the treatment of monkeypox, but it is available in the United States through an emergency use pathway requiring a formal written request to the FDA.
  • Many physicians have called on the federal government to make the medication more available, including at local pharmacies.

Statistics:

  • Nearly 10,000 monkeypox cases have been reported across the United States.
  • 3,000 monkeypox cases were reported in the past week alone.
  • TPOXX has been highly effective in treating monkeypox, with 100% efficacy rate in several reported cases.

Sources:

  • Centers for Disease Control and Prevention (CDC), Guidance for Tecovirimat Use Under Expanded Access Investigational New Drug Protocol During 2022 U.S. Monkeypox Cases (Aug. 3, 2022)
  • Food and Drug Administration (FDA), Expanded Access to Investigational Drugs for Treatment Use--Questions and Answers, Guidance for Industry (online at www.fda.gov/media/85675/download)
  • European Medicines Agency, Tecovirimat Siga (online at www.ema.europa.eu/en/medicines/human/EPAR/tecovirimat-siga#authorisation-details-section)
  • Medical Society of the State of New York, Press Release: MSSNY Urges Biden Administration to Declare a Public Health Emergency (Aug. 1, 2022)
  • SIGA Technologies, Inc., Press Release: SIGA Technologies Receives Approval from the European Medicines Agency for Tecovirimat (Jan. 10, 2022)

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