Senator calls on Administration officials to expedite the process for obtaining the antiviral tecovirimat, which may benefit patients with Monkeypox

Washington (July 26, 2022) – Senator Edward J. Markey (D-Mass.) today sent letters to the Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) urging them to improve access to antiviral treatments for Monkeypox. With demand for Monkeypox vaccines outpacing supply, the federal government should use all available tools to combat the virus and support patients in need. In his letter, Senator Markey called upon the officials to reduce barriers to obtaining tecovirimat, an antiviral approved for treatment of smallpox that has been shown to be effective in treating orthopoxviruses like Monkeypox with minor side effects. The U.S. has over 1.7 million courses of tecovirimat in the Strategic National Stockpile, but health care providers must follow an extensive, time-consuming protocol to provide the drug to patients. Leading public health organizations, including the Infectious Diseases Society of America, have urged federal health officials to reduce procedural barriers required to obtain tecovirimat.

“To ensure the United States is utilizing all available tools to combat Monkeypox and to improve equity in the federal government’s response to the virus, I urge the Department of Health and Human Services (HHS) and CDC, in coordination with the Food and Drug Administration (FDA), to reduce barriers to treatments for Monkeypox,” wrote Senator Markey. “In particular … tecovirimat has been shown effective in treating disease caused by orthopoxviruses like Monkeypox.”

“Given the limited supply of vaccine and growing Monkeypox cases, the United States must use additional tools to respond to the outbreak, including expanding access to tecovirimat, to support patients suffering from this disease,” the Senator continued. “To improve access to tecovirimat, CDC and FDA must move quickly to reduce barriers to prescribing tecovirimat and communicate to health care providers the process for obtaining the drug.”

The letters ask for a response to the following by August 8th:

1. CDC and FDA recently announced a streamlined expanded access protocol for obtaining tecovirimat. What steps have your agencies taken to communicate this to providers in areas with Monkeypox outbreaks? Have you solicited feedback from providers about ways the protocol could be further improved?
2. Would you consider further changes to the protocol for obtaining tecovirimat, if clinical evidence supports expanded use?
3. Has CDC, FDA, or HHS explored supporting other forms of data collection for use of tecovirimat, including clinical trials, patient registries, or observational studies, that may enhance access to the treatment?
4. In addition to tecovirimat, the Strategic National Stockpile contains other treatments that may benefit patients with Monkeypox. Have you considered taking steps to increase access, in the form of clinical trials or expanded access protocols, for these treatments?
5. Do you need additional support from Congress, such as additional funding or regulatory authority, to support access to treatments for Monkeypox?

Read the full text of the letters HERE.

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