“The Covid-19 pandemic demonstrated America’s vulnerability to catastrophic public health crises and underscored the urgency of taking reasonable steps to prevent them in the future,” said Sen. Todd Young, R-Indiana and one of the bill’s co-sponsors. e-mail. “The next public health crisis is here: the emergence of bacteria resistant to antibiotic treatment.”
In a letter to Congress in November, opponents of the measure said it would encourage the development of ineffective drugs, in part because of what they described as flaws in the FDA’s existing approval process for antibiotics. “Under the Pasteur Act, taxpayer dollars will be wasted as a blank check to pharmaceutical manufacturers for antimicrobials of limited benefit,” they wrote.
One of the signatories, Dr. Reshma Ramachandran, an assistant professor at the Yale School of Medicine, said the bill leaves in place a regulatory regime for antibiotics that she and others believe allows companies to market drugs of questionable value. Their objection to the status quo centers on a central tenet of the FDA’s antibiotic review process: New drugs can be approved under a concept known as noninferiority, which allows new drugs to be less effective than the existing ones Dr. Ramachandran, whose work focuses on antimicrobial resistance and health policy, and other critics of the bill said the FDA should adopt a system that requires drugmakers to demonstrate that new antibiotics are higher than the current ones.
“As a physician, it is of great concern to me that we can have expensive new drugs on the market without regulatory oversight to ensure that these drugs are clinically meaningful or even address resistant infections,” said Dr. Ramachandran said.
Many experts, however, say this approach is impractical and raises ethical questions. To establish whether a new antibiotic is superior to existing ones, researchers should conduct clinical trials that test the new therapy against a placebo or a drug they know is less effective. For study participants fighting an infection, getting a placebo or an inferior drug could prove fatal.
“This whole notion of superiority doesn’t make sense. We don’t have a drug with that standard,” said Kenneth E. Thorpe, a Clinton administration health policy official who is an adviser to the advocacy group Partnership to Fight Infectious Disease. “We need to drive innovation and get as many new antibiotics as we can given the diversity of infections and the threat to human health if we fail.”