Speaking at an event held in Washington D.C., by the Pew Charitable Trust, FDA Commissioner Dr. Scott Gottlieb on Friday described the approach as an “agency-wide” effort to encourage product stewardship as well as support efforts to better track antimicrobial resistant outbreaks.
“We can’t count on outracing drug resistance,” Gottlieb said. “But we can use stewardship and science to slow its pace and reduce its impact on human and animal health.”
Much of the plan involves changing the current reimbursement structure for antibiotics. Gottlieb said many large pharmaceutical companies have opted out of investing in new antibiotic medications over the past few decades because antibiotics are meant to be used sparingly as a last line of defense. Antibiotics overprescribing has led to a rise in antimicrobial-resistant bacteria that providers are finding difficult to treat.
“If we want to maintain a robust pipeline for antibiotics, it is necessary to change the perception that the costs and risks of antibiotic innovation are too high relative to their expected gains—without weakening antibiotic stewardship,” Gottlieb said. “It is important to pursue new policies and reimbursement approaches now, to shift the investment landscape right away.”
Gottlieb said the agency is working on a new subscription-based payment model that would require hospitals to pay a flat rate for access to a certain number of doses of new antibiotics.
“This should have the effect of creating a natural market for drugs that meet certain important specifications,” Gottlieb said.
Drug companies and governments have sought for years to find a new market model that would incentivize pharmaceutical firms to develop new antibiotics as the pipeline tightens. A recent Pew analysis of antibiotics currently in development found there were 42 with the potential to treat serious bacterial infections. Yet only one in five drugs that enter clinical trials eventually get approved for use on patients. The majority fail.
The dearth of new antibiotics has made the threat of anti-resistant pathogens even more dangerous, with health experts fearing we are getting closer to a time when there will be no antibiotics to treat the newest infections.
An estimated two million people in the U.S., develop serious infections caused by antimicrobial-resistant bacteria each year, according to the Centers for Diseases and Prevention, resulting in at least 23,000 deaths.
Of the 42 drugs in development, three-quarters belong to existing classes of antibiotics where bacterial resistance has already been observed or could easily develop. Eleven antibiotics have the potential to treat infections where the World Health Organization says there is a “critical” need to develop new antibiotics, while only one has the potential to treat Gram-negative bacteria, which are associated with some of the hardest-to-treat infections.
Gottlieb said the agency has talked with the CMS about a subscription-based model within Medicare, but that those discussions were still in their early stages. He didn’t see the subscription-based model as something that would encompass the entire healthcare market, but rather it would be reserved for the large healthcare organizations that are more likely to use the kinds of antibiotics targeted to treat multi-drug resistant pathogens.
“It would provide enough of a foundation of a guaranteed market that would help more companies get over the hurdle of making investments in new drug development in this area,” Gottlieb said. “If the goal is to develop a drug that you don’t have to use, there’s no market for that.”
Gottlieb also announced on Friday the release of the FDA’s five-year plan to promote antimicrobial stewardship in veterinary settings.
Meat producers previously have used antibiotics with no veterinary oversight as a means of staving off infections in livestock. Some producers have also used such drugs within the feed and drinking water of food-producing animals to help them gain weight. Some of the drugs that were used had medical importance to humans and raised concerns of pathogens adapting and becoming resistant.
Over the past several years, the FDA has issued regulations on veterinary antibiotics that have included requiring drug makers to put warning labels on their products that warn against using it for growth promotion, a move that has resulted in label updates to nearly 300 products and veterinary oversight over 95% of medically-important antimicrobial products, according to Gottlieb.
He said the agency from now on will focus on requiring veterinary oversight over the remaining 5% of medically-important antibiotics still in use, with plans to issue draft guidance that will help the industry make changes by the end of 2019.