As one of the worst influenza outbreaks in recent history continues to spread in the United States, the release of a new drug that could quickly cure the illness is being delayed by Food & Drug Administration’s (FDA) overly cumbersome approval process.
Centers for Disease Control and Prevention acting director Dr. Anne Schuchat held a conference call on February 16 addressing widespread flu activity. Flu-related illnesses approached historic levels as increasing numbers of Americans were becoming infected with the virus.
“Hospitalization rates are significantly higher than what we’ve seen for this time of year since our current tracking system began almost a decade ago,” Schuchat said.
As of February 24, the most recent data for which CDC statistics were available at press time, about 81 per 100,000 Americans were hospitalized because of influenza symptoms since October 1, 2017. Pneumonia and influenza caused 9 percent of all reported deaths occurring that week, according to CDC. Pneumonia is a common outcome of influenza infections.
The new drug, Xofluza, was invented by researchers for Shionogi, a Japanese pharmaceutical company. Japan’s Health, Labor, and Welfare Ministry cleared Xofluza for sale to consumers on February 23, four months after Shionogi began the approval process.
Xofluza will not be available to U.S. consumers until at least 2019 because of the much more lengthy FDA process.
‘Not a Huge Safety Risk’
Devon Herrick, a policy advisor for The Heartland Institute, which publishes Budget & Tax News, says the benefits of a potential influenza cure far outweigh the risks.
“One pill that’s already gone through safety testing in earlier stages of clinical trials is not a huge safety risk,” Herrick said. “It’s only one pill per patient, but it could save lives and billions in costs.”
Herrick says the drug has been sufficiently tested, and the FDA bureaucracy is standing in the way.
“The drug has already been tested in both Japanese and American patients in late-stage clinical trials,” Herrick said. “Japan has similar safety standards for approving drugs as the United States, yet the company has not yet submitted an application in the U.S., likely because of the bureaucratic obstacles.”
Wayne Winegarden, a senior fellow in business and economics for the Pacific Research Institute and a policy advisor for The Heartland Institute, says the FDA approval process is paralyzed by fear of failure.
“The most important thing is the conservatism of the regulations, making sure the safety is at a certain point and making sure the flu drug won’t have any [adverse] consequences,” Winegarden said. “That extra caution has consequences as well. In any government bureaucracy, you’re going to see that you don’t want to make an error of commission, so you’ll make worse errors of omission, to avoid taking the blame for that.”
Government ‘Denying Timely Access’
FDA and other large regulatory agencies naturally gravitate toward extreme caution, Winegarden says.
“Organizationally and culturally, there’s going to be a natural bias against making errors of commission, so you end up with situations where there’s a flu drug that the Japanese have deemed to be worth the costs but we’re going to have it delayed,” Winegarden said. “That conservatism is denying us timely access to it.”
Follow the Leader
Winegarden says one solution to FDA’s paralysis would be to allow people to try drugs yet to receive full approval under the agency’s lengthy review process.
“If there were drugs approved for use in Japan like this drug, why can’t we have a reciprocity, where people could just sign a form saying ‘I understand that it is not cleared by the FDA’ but giving people the right to use it under an informed assumption of risk?,” Winegarden said.