‘We Need To Change the Way We Pay For Antibiotics’

On late Tuesday, a new antibiotic, sulbactam-durlobactam (Xacduro), was FDA approved. However, approvals of this class of medications are very limited overall. There has been a dearth of antibiotic approvals in recent years. From 2017 to 2021, just one new antibiotic, cefiderocol, was FDA approved. A big reason for this is the system in which pharmaceutical companies operate.

There are some inherent challenges behind developing and getting antibiotics approved.

For starters, it takes 10 to 15 years from development to FDA approval for antibiotics. Another significant challenge explains Kevin Outterson, JD, founder and executive director, Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) and board member of Partnership to Fight Infectious Disease (PFID), is that smaller companies are mainly developing antibiotics. Much of the bigger pharmaceutical companies have exited the space. With limited funding, these smaller companies may not be able to see drug development all the way through to final approval explains Outterson, and for those that do, the medical field may ask these companies to preserve these new medicines and use them sparingly.

Organizations such as CARB-X and PFID have been involved in antibiotic development and advocacy and are trying to move towards increased development and final approval of antibiotics.

The former group helps in funding early development pipeline of new antibiotics, vaccines, rapid diagnostics, and other products. Outterson explains they have aided in 18 investigational therapies getting from early development into human clinical trials.

The latter group is made up of various infectious disease experts and stakeholders working to raise awareness of threats posed by infectious disease.

Outterson says people equate antibiotics to “infrastructure maintenance.” It has a very significant role to play, but it is not a topic people want to discuss, until there is a breakdown and people notice it.

“For antibiotics, it has been hard to get people to understand that they are a safety net or a piece of infrastructure that protects all of modern medicine,” Outterson stated. “Today we spend billions of dollars on cancer treatments, but the number 2 cause of death for people with cancer is bacterial infection. So much of what we do in modern medicine would be harder, more expensive, more dangerous, if we didn’t have antibiotics.” 

This last fact bears out. In the United States, there are more than 2.8 million antibiotic-resistant infections that occur annually and at least 35,000 people die as a result, according to the CDC’s Antibiotic Resistance Threats in the United States report. According to a study published in The Lancet, an estimated 1.27 million deaths worldwide were directly caused by AMR, and AMR played a part in nearly 5 million deaths, in 2019. This makes AMR a leading cause of death globally. Yet, this current paradigm has not changed.

However, there is some promising developments that may begin to change the existing paradigm in drug development and offer a new way to get more into the pipeline and across the regulatory finish line.

The Pasteur Act: A Subscription Based-Model
The Pioneering Antimicrobial Subscriptions to End Up surging Resistance (PASTEUR) Act, is a bipartisan, bicameral piece of legislation aimed to incentivize innovative drug development targeting the most threatening infections, improve the appropriate use of antibiotics, and ensure domestic availability when needed.

The PASTEUR Act was initially introduced in Congress by Michael Bennet (D-CO) and Todd Young (R-IN) in September of 2020. Bennet and Young along with Representatives Mike Doyle (D-PA) and Ferguson reintroduced the bill in June 2021. It was Senators Bennet and Young and Representatives Drew Ferguson (R-GA) and Scott Peters (D-CA), who reintroduced the Pasteur Act in Congress just recently.

A significant piece of the legislation is its subscription model, which would change how pharmaceutical companies are compensated for developing antibiotics.

“Pasteur pays for the access to the drug,” stated Outterson. “The company will get steady payments to the drug over a decade until the patent expires. In exchange for that, we get as much as we need, whether it is a little or a lot.”

Outterson says this subscription model is being done in the United Kingdom and that Japan has announced plans to do so as well.

Contagion spoke to Outterson recently who provided some background on CARB-X, the current challenges associated with antibiotic development today, and the prospective number of people that could be saved if the Pasteur Act is passed.