The Food and Drug Administration (FDA) wants Congress to pass a bill to help the agency combat the scourge of germs that have grown resistant to antibiotic drugs.
Legislation would allow the agency to create a program to develop special drugs designed to attack so-called “superbugs” that have become resistant to other medicine, the director of FDA's drug evaluation center, Janet Woodcock, said on Thursday.
“What we’ve been discussing is that Congress would speak on this and tell us to establish a program,” she told a House Oversight subcommittee, noting that going through a normal rule-making process could take years.
Rep. James Lankford (R-Okla.), chairman of the Oversight subcommittee on Energy Policy, Healthcare and Entitlements, said that the FDA should start work on its own, because congressional action could take too long.
“My preference, and I’m not going to speak for all of us, would be for you to get started on what you feel like you have statutory authority for now so we can have something of a process,” he said. “I would hate for FDA to sit back for two or three years to wait for us to get something done and then, once it’s done, you promulgate rules based on that and then we’re even farther behind.”
The top Democrat on the subcommittee, Rep. Jackie Speier (D-Calif.), was less pessimistic.
“It looks like there is agreement from all areas and so if we just focus on antibiotics, I think we can get this [special medical use label] moving forward,” she said. “I would like to work with [Lankford] to see if we can do that together, jointly. We’ll see what we can do.”
At least 2 million people are infected with drug-resistant bacteria in the United States each year, according to the Centers for Disease Control and Prevention, and at least 23,000 people die as a result of those illnesses.
“The need is very great,” Woodcock said. “We are behind that epidemic.”
She explained that the program would allow the FDA to “speed the introduction of antibiotics for drug-resistant organisms.”
Drugs developed to combat those bacteria could come with a special mark or label, she said, so that prescribing doctors can be sure to use “good antibiotic stewardship” to limit their widespread use.
On Wednesday, the FDA released plans to phase out the use of antibiotics in meat, which can foster the growth of drug-resistant strains of bacteria.
The voluntary program would encourage farmers to limit the drugs they feed their livestock. Food safety advocates worry that farmers who rely on the drugs can be breeding antibiotic-resistant organisms in their animals, which can be transferred to humans.