US lawmakers re-introduce the PASTEUR Act
US lawmakers today re-introduced a bill to reinvigorate the antibiotic development market.
Originally introduced in September 2020, the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act would establish a subscription-style payment model for new antibiotics, under which companies that develop innovative, critically-needed antibiotics for drug-resistant infections would receive a contract from the federal government ranging from $750 million to $3 billion. In return, the drug would be made available for patients covered by federal insurance programs, and the companies would be required to support appropriate use and post-marketing studies.
The model would be fully de-linked, so companies that receive contracts would not receive income based on sales volume. The sales-based model has hindered antibiotic development because antibiotics are expensive to develop but are used for short periods of time and need to be used judiciously to maintain their effectiveness, and therefore don't generate enough revenue for companies. Many large pharmaceutical companies have abandoned antibiotic development, while smaller companies struggle to survive.
The aim of the bipartisan legislation, which was re-introduced by Sen. Michael Bennet (D-Colo.), Sen. Todd Young (R-Ind.), Rep. Mike Doyle (D-Pa.), and Rep. Drew Ferguson (R-Ga.), is to help address the broken market for new antibiotics and ensure domestic availability when needed.
"Tens of thousands of Americans die each year from antimicrobial-resistant infections," Rep. Doyle said in a press release. "Infectious disease experts agree that antimicrobial resistance is an urgent public health threat that requires a comprehensive, effective solution now. The PASTEUR Act will help scientists and researchers bring better antimicrobials to market, and it will help hospitals and doctors ensure these drugs are used properly."
Antibiotic resistance and development experts say the legislation is necessary for fixing the antibiotic pipeline and addressing the growing threat of drug-resistant infections.
"The bipartisan PASTEUR Act would establish a new avenue of federal support for the development of new antibiotics that are critically needed for patient care and public health," the Infectious Diseases Society of America (IDSA) said in a statement. "IDSA will continue to urge Congress to advance the PASTEUR Act and the important solutions to a national health crisis that it provides."
Jul 16 Senate press release
Jul 16 IDSA statement
WHO supports shorter regimen for drug-susceptible TB
The World Health Organization (WHO) said this week that, based on data from a recent phase 3 clinical trial, it will recommend a shorter treatment regimen for drug-susceptible tuberculosis (TB).
In a rapid communication intended to inform national TB programs, technical partners, and other stakeholders, the WHO said a review of Study 31 findings by members of the Guideline Development Group indicated a 4-month regimen composed of rifapentine, isoniazid, pyrazinamide, and moxifloxacin was non-inferior to the standard 6-month regimen for drug-susceptible pulmonary TB and was equally well tolerated.
The trial, which involved more than 2,500 newly-diagnosed TB patients from 13 countries, compared two 4-month regimens, one with moxifloxacin and one without, to the standard 6-month regimen. The results were published May 6 in the New England Journal of Medicine.
The 6-month regimen has been the standard for drug-susceptible TB for decades, but the TB treatment community has long sought a shorter regimen that could improve treatment adherence and reduce drug costs and adverse effects.
"The 4-month regimen, which is shorter, effective and all-oral, would be a preference for many patients and also national TB programmes, allowing faster cure and easing the burden on both patients and the healthcare system," the WHO said, adding that the implementation and uptake of the regimen will be more feasible if the cost of rifapentine is reduced. The agency also noted that appropriate use of the regimen will need to be ensured, since moxifloxacin is usually used for treatment of drug-resistant TB.
The WHO said updated guidelines for drug-susceptible TB treatment will be released later in 2021.
Jun 14 WHO rapid communication
May 6 N Engl J Med study