Maloney calls on HHS to reduce barriers to monkeypox therapy

House Oversight & Reform Chairwoman Carolyn Maloney is urging HHS Secretary Xavier Becerra to improve access to monkeypox therapy Tpoxx by streamlining expanded access protocols.

In an Aug. 10 letter to Becerra, Maloney cites the severity of the outbreak — it’s been declared a public health emergency in the U.S. — and contrasts the regulatory status of Tpoxx tecovirimat in the U.S. with Europe, where the antiviral is authorized or approved. While FDA and CDC have taken measures to streamline expanded access IND protocols, she said that the measures have not reduced hurdles to accessing the therapy. ...