Can Federally Funded ‘Netflix Model’ Fix Broken Market for Antibiotics?

“The Covid-19 pandemic has demonstrated America’s vulnerability to catastrophic public health crises, and it highlights the urgency to take reasonable steps to prevent them in the future,” said Senator Todd Young, Republican of 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 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 describe as flaws in the FDA’s approval process for antibiotics. “Under the Pasteur Act, taxpayer dollars would be wasted on drug manufacturers as a blank check for limited antimicrobials,” they wrote.

One of the signatories, Yale School of Medicine Assistant Professor Dr. Reshma Ramachandran, who she and others argue, puts regulatory provisions on antibiotics in the bill that allows companies to market drugs of dubious value. His objection to the position centered on a central tenet of the FDA’s antibiotics review process: that new drugs can be approved under a concept known as non-inferiority, which allows novel drugs to be less effective than existing drugs. Dr. Ramachandran, who focuses on antimicrobial resistance and health policy, and other critics of the bill said the FDA would have to follow a system where drugmakers demonstrate that new antibiotics are better than existing ones.

“As a physician, it’s a big concern for me that new expensive drugs can be put on the market without regulatory oversight to ensure that these drugs make clinical sense or that they even address resistant infections,” Dr. Ramachandran said.

However, many experts say such an approach is impractical and raises ethical questions. To establish whether a new antibiotic is better than an existing one, researchers must conduct clinical trials that test the new treatment against a placebo or drug. For study participants fighting infections, receiving a placebo or substandard drug can be dangerous.

“This whole notion of superiority is meaningless. We don’t hold any drug to that standard,” said Kenneth E. Thorpe, a Clinton administration health policy official who is a consultant to the advocacy group. Coalition to Fight Infectious Disease. “We need to spur innovation and get access to the diversity of infections and the many new antibiotics that could pose a threat to human health if we fail.”

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