Today, Rep. Carolyn B. Maloney, Chairwoman of the Committee on Oversight and Reform, sent a letter to Xavier Becerra, Secretary of the Department of Health and Human Services (HHS) urging HHS to take all steps necessary to ensure patients can safely and easily access the antiviral medication TPOXX (tecovirimat) for the treatment of monkeypox, including any steps required to evaluate a potential emergency use authorization for TPOXX to treat the monkeypox virus. Chairwoman Maloney issued the following statement on today’s letter:
“While I am pleased that the Biden-Harris Administration has heeded my calls to declare the monkeypox outbreak a public health emergency and speed up the federal response, I remain troubled that patients and health care providers are continuing to face hurdles accessing treatment. As more patients become infected, the Administration must ensure that every person can safely and easily access monkeypox treatment, including TPOXX, while also working to contain the spread of the virus. That’s why today, I’m calling on the Department of Health and Human Services to take all necessary steps to make TPOXX more accessible—including steps to evaluate a potential emergency use authorization—so that we can ensure patients receive the very best care and help protect our communities during this public health emergency.”
According to the Centers for Disease Control and Prevention (CDC), nearly 10,000 monkeypox cases have been reported across the United States, including nearly 3,000 cases reported in just the past week. Although the Administration has taken crucial steps to promote access to monkeypox treatment, health care providers and monkeypox patients report continued difficulties in prescribing and obtaining TPOXX.
Currently, TPOXX is only available in the United States through an emergency use pathway that requires the submission of a formal written request to the Food and Drug Administration (FDA). While the CDC and FDA streamlined the process for doctors to prescribe TPOXX last month, health care providers report that the paperwork requirements remain so burdensome that some providers are choosing not to prescribe TPOXX to patients.
Providers who have overcome these administrative hurdles and prescribed TPOXX to patients have reported that the drug has been highly effective in treating monkeypox, with lesions in several instances reportedly disappearing within days of initiating treatment. As a result, many physicians have called on the federal government to make the medication more available, including at local pharmacies.
In other countries experiencing monkeypox outbreaks, TPOXX has already been authorized or approved to treat patients infected with the monkeypox virus. The European Medicines Agency authorized use of TPOXX to treat monkeypox in January, and the United Kingdom approved TPOXX for the treatment of monkeypox in July.
In her letter, Chairwoman Maloney called on HHS to further streamline its new drug requirements so that physicians and patients can more easily access TPOXX, and to take all necessary steps for the federal government to consider a potential emergency use authorization for the drug to treat monkeypox.
Original source can be found here.
