“You have the problem of people coming into the U.S. who have superbugs that they’re resistant to, and then having to be tested for them,” said Paul Mazzetti, executive director of the UCR Alliance.
“They’re using the same antibiotics that we’re using to treat infections.
It’s not a great picture.”
Mazzetti, who lives in Philadelphia, said his nonprofit, which advocates for antibiotic-resistance reduction, was among several groups who sued to stop the new rule.
“The question is: How do we stop the spread?” he said.
The Trump administration, however, has been trying to push through the rules without public input.
A recent draft of the regulations had to be withdrawn after the Senate rejected it.
“This is not the right time to start talking about changing this,” said Elizabeth Kaptur, a senior fellow at the Cato Institute who is also a member of the alliance.
“I think there’s a very strong case that we should wait to see how it evolves before moving forward.”
She called the new rules a “very significant shift in the rules.”
Mrazetti and Kaptus said the group is trying to influence what the federal government does, including by urging lawmakers to support the new FDA rules.
“We are the best advocates for drug testing,” Mrazetti said.
“And we are the only ones that have seen these rules being put into place.”
The FDA did not immediately respond to a request for comment.
The FDA rules would also prohibit states and localities from requiring drug companies to test patients.
The new rules also would require all drug companies selling antibiotics to have a written plan to use the drugs only in the most extreme cases, including in emergency situations.
They would also require companies to report the frequency of antibiotic use.
The rules would require companies with more than 5,000 employees to post a detailed, daily medical record that describes how frequently antibiotics are used and the types of infections caused by them.
If a drug is not used within 24 hours, it would be required to be discarded.
The final rule is expected to go to the president’s desk this summer.
The draft of FDA regulations had sparked opposition from groups like the American College of Obstetricians and Gynecologists, the American Medical Association, the Center for Food Safety and the Physicians Committee for Responsible Medicine.
The group wrote a letter last month urging the Trump administration to “not act hastily” and instead “immediately” take the steps necessary to end the use of antibiotics in agriculture.
“A complete reversal of the trend of antibiotics being used to treat antibiotic-associated infections will send a very powerful signal to the industry, to the US economy, and to the world that antibiotics are not the answer,” said Stephanie A. Whelan, a spokeswoman for the American Academy of Pediatrics.
Wepner, who is based in New York, said that if the rules are finalized, the FDA will likely change the way it tests drugs, and that some drugs will be banned.
The agency said it was already considering changes to how it conducts drug tests and said it has “serious concerns” about the new standards.
“As with any regulatory system, FDA will continue to monitor the impact of these proposed changes on the safety and efficacy of our drugs and the public health,” said Michael B. Antonov, the agency’s assistant director of regulatory affairs.
The proposed rule is part of a $50 billion plan to tackle the drug-resistant bacteria that have infected millions of people.