“The Covid-19 pandemic has demonstrated America’s vulnerability to catastrophic public health crises, and it has underscored the urgency of taking reasonable steps to prevent them in the future,” said Senator Todd Young, a Republican from Indiana and one of the bill’s co-sponsors. an email. “The next public health crisis is already here: the emergence of bacteria resistant to antibiotic treatments.”
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 describe as flaws in the current FDA approval process for drugs. antibiotics. “Under the Pasteur law, taxpayers’ money will be wasted like a blank check to pharmaceutical manufacturers for limited-benefit antimicrobials,” 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 say allows companies to market drugs of questionable value. His objection to the status quo centers on a central tenet of the FDA’s antibiotic review process: New drugs can be approved based on a concept known as non-inferiority, which allows new drugs to be less effective. than existing drugs. 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 prove new antibiotics are superior to the current ones.
“As a clinician, I am extremely concerned that we may have expensive new drugs on the market without regulatory oversight to ensure that these drugs are clinically meaningful or that they even treat resistant infections,” said Dr. Ramachandran.
Many experts say, however, that such an approach is impractical and raises ethical questions. To determine if a new antibiotic is superior to existing antibiotics, researchers should conduct clinical trials that test the new therapy against a placebo or a drug they know is less effective. For study participants who are battling an infection, getting a placebo or substandard medication could prove deadly.
“This whole notion of superiority makes no sense. We don’t hold any drugs to that standard,” said Kenneth E. Thorpe, health policy officer in the Clinton administration and adviser to the advocacy group Partnership to Fight Infectious Disease. “We need to drive innovation and get as many new antibiotics as possible given the diversity of infections and the threat to human health if they fail.”
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