Forging an Evolutionary Regulatory Path for Antibiotic Development

Welcome to Contagion’s podcast, Contagion Community, where we delve into factors that create and widen health care disparities.

Although the development of antibiotics remains a challenge, there are some legislative strategies that could make it more attractive and get more players involved.

On the fourth episode of the Contagion Community podcast, Evan Loh, MD, the CEO of Paratek Pharmaceuticals, discusses passing federal legislation to improve antibiotic development and reduce antimicrobial resistance.

Antimicrobial resistance (AMR) has been an ongoing public health problem for many years. A global analysis published in The Lancet back in January estimated that antimicrobial resistance was the leading cause of death worldwide in 2019. Investigators estimated that resistance itself caused 1.27 million deaths that same year, and that antimicrobial-resistant infections played a role in 4.95 million deaths.

It has been something the medical community is quite aware of and has tried to do its part by developing antimicrobial stewardship programs at hospitals and medical centers to reduce the burden of AMR. Another issue within this public health concern has been antibiotic development. With it taking so many years to create new therapies, and reimbursement less attractive, larger pharmaceutical companies have left antibiotic development altogether. These life-saving medicines have become the domain of small, independent biopharmaceutical companies.

Combine those issues with 2 years of the COVID-19 pandemic, and this significant health topic has been shelved for some time.

Paratek Pharmaceuticals is a good example of a company in the antibiotic space. This smaller company has developed an FDA-approved tetracycline-class antibiotic for adult patients with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. This antibiotic is also being studied for a variety of other potential indications.

The company is part of the Antimicrobials Working Group, which has a mission to “improve the regulatory, investment, and commercial environment for antimicrobial drug and diagnostic device development to provide doctors and patients with innovative infectious disease treatment options.”

Paratek’s CEO Evan Loh, MD, is passionate about these life-saving medicines and has been active in his support of the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2021 (DISARM) Act, which is a bill in Congress. “This bill requires additional payment under Medicare's inpatient prospective payment system for services that involve certain antimicrobial drugs, in accordance with specified limitations. Additionally, the Government Accountability Office must report on the barriers to developing such antimicrobial drugs and must recommend ways to address such barriers,” the language of the bill reads.

Along with governmental advocacy, Loh also sees the value in public and private partnerships to enable greater involvement in the antimicrobial space.

Loh spoke with Contagion about the challenges of developing antibiotics and providing incentives such as the DISARM act to attract more pharmaceutical companies to get involved in developing these vital medicines.

Listen in on the conversation and feel free to offer your feedback on this episode, interest in participating in the podcast, or suggest ideas for future episodes. Please email your correspondence to Nina Cosdon: ncosdon@mjhlifesciences.com.