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READI Act offers incentives for new antibiotics, rapid diagnostics
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Legislation introduced in the U.S. House of Representatives late Thursday would provide companies with incentives, including a tax credit, to spur the development of new antibiotics and rapid diagnostic tests.
The Reinvigorating Antibiotic and Diagnostic Innovation (READI) Act was introduced by U.S. Reps. Erik Paulsen (R-Minn.) and Mike Thompson (D-Calif.) and has been supported by dozens of medical organizations and drug companies as an urgently needed effort to address the global threat of antimicrobial resistance.
According to the Infectious Diseases Society of America (IDSA), the READI Act’s tax credit is modeled after the one offered under the Orphan Drug Act for treatments of rare diseases or conditions. According to the IDSA, the tax credit would provide relief for companies developing new antibiotics that treat a serious or life-threatening infection and address an unmet medical need, as well as new rapid diagnostics.
The IDSA said it welcomed the READI Act and would work closely with Paulsen and Thompson to advance the legislation. The organization was one of 41 signees of a letter addressed to Paulsen and Thompson supporting the READI Act.
“The growing threat of antibiotic resistance is making increasing numbers of infections difficult or impossible to treat, underscoring the urgent need for new antibiotics,” William Powderly, MD, IDSA president and co-director of the division of infectious diseases at Washington University in St. Louis, said in a statement. “Rapid diagnostic tests are equally essential. Without rapid tests, we must often treat empirically — before we know exactly what type of infection a patient has — which can lead to antibiotic overuse.”
According to the CDC, at least 2 million people are infected with antibiotic-resistant bacteria each year, resulting in about 23,000 deaths.
“Antibiotic resistance is threatening our ability to provide many types of medical care — including solid organ and bone marrow transplants, joint replacements, cancer chemotherapy, care of preterm infants, and care of deep combat wounds and burns in our military service men and women — all of which rely on the availability of safe and effective antibiotics,” Johan S. Bakken, MD, PhD, FACP, FIDSA, past president of IDSA and infectious disease physician in Duluth, Minnesota, said in a statement.
Despite previous congressional actions such as the Generating Antibiotic Incentives Now (GAIN) Act and the 21st Century Cures Act, the IDSA said the antibiotic pipeline is still "fragile.” Most pharmaceutical companies withdrew from research and development because antibiotics are expensive to develop and do not bring in large profits, according to Henry F. “Chip” Chambers, MD, IDSA board member and chief of the division of infectious diseases at Zuckerberg San Francisco General Hospital.
“They are typically inexpensive and taken for a short duration, unlike many drugs for chronic diseases,” he said in a statement. “Further, we aim to limit antibiotics’ use, because overuse drives the development of resistance and renders them ineffective. This is a phenomenon unique to antimicrobial drugs. The READI Act will provide a much-needed incentive for companies to develop the new antibiotics that patients so desperately need.” – by Stephanie Viguers and Gerard Gallagher
Disclosure: Infectious Disease News was unable to confirm relevant financial disclosures at the time of publication.
Perspective
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Barbara Murray, MD
As an infectious diseases physician, I see firsthand the urgent need for new antibiotics and rapid diagnostic tests. My colleagues and I are caring for increasing numbers of patients with very serious infections that are extremely difficult to treat due to antibiotic resistance. Our therapeutic options are diminishing, as so few companies are working to develop new antibiotics. Heartbreakingly, I have been forced to send patients to hospice because we lacked any safe and effective antibiotics for their infections. Numerous expert studies and reports have repeatedly called for economic incentives to stimulate the research and development of the most urgently needed new antibiotics. Overall, new antibiotics for multidrug-resistant organisms are difficult and costly to develop and not profitable. The READI Act would help do for antibiotics what the Orphan Drug Act did for rare disease treatments — make it more financially feasible for companies to discover and develop new antibiotics by providing a tax credit to support clinical development costs. In addition, the READI Act would encourage the development of new rapid diagnostic tests, which are essential to help guide our appropriate use of antibiotics and preserve their utility. I am heartened by Rep. Paulsen's and Rep. Thompson's bipartisan leadership on this important issue and urge Congress to enact the READI Act.
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