Doctors who want to prescribe tecovirimat, or Tpoxx, must navigate a gantlet of bureaucratic hurdles that experts say could be quickly lifted. The only drug available to treat monkeypox is so difficult to access that just a fraction of the nearly 7,000 patients in the United States have been given it.
Health officials have designated tecovirimat, also called Tpoxx, an “investigational drug,” which they say means it cannot be released from the strategic national stockpile without a series of convoluted bureaucratic steps. But most doctors do not have the time or resources to fill out the required 27-page application or to provide the detailed patient information. It doesn’t have to be this way, experts say: There is no law preventing federal officials from changing those rules and making the drug more widely available. The Food and Drug Administration approved tecovirimat as a smallpox treatment in 2018, based on safety data in people and efficacy data in primates — which, for the purposes of the trial, actually were infected with monkeypox. The so-called animal rule allows the agency to approve drugs when testing them in people would be unethical
Until the current outbreak, tecovirimat was given only rarely to monkeypox patients. As a smallpox treatment, its use against monkeypox is considered experimental. But vaccines developed for smallpox have been assumed to be effective against both diseases. Why not the treatment? Experts say the F.D.A.’s restrictions are a policy choice that can be quickly altered. “The bureaucracy of gaining access to Tpoxx is excessive given the crisis the U.S. is facing with monkeypox,” said Larry O. Gostin, an expert on public health law and director of the O’Neill Institute for National and Global Health Law at Georgetown University.
Source: This news is originally published by nytimes