The global antimicrobial resistance crisis has been exacerbated by the fact that the number of new antimicrobials developed and approved has decreased significantly over the past three decades, leaving fewer options for the treatment of resistant bacteria. Due to economic and regulatory obstacles, our nation’s scientific community has shifted its attention away from the development of new antimicrobials that could combat resistant infections.
Only 6 of the top 50 pharmaceutical companies in the world are still developing or studying antimicrobials, and over 80% of the products in development are being studied by smaller companies; nearly half of which are considered pre-revenue. The current market and regulatory climates make it extremely difficult for these small companies to attract the necessary levels of investment to fund the scientific research and development required to produce these vital products.
The companies that continue to pursue development face a myriad of regulatory hurdles including evolving standards for clinical trial design, which can have a great impact on size and cost of a clinical trial, and a lack of expedited approval pathways. Typically, only 1 in 5 infectious disease products that reach human testing (phase 1) will be approved for patient use.
Furthermore, the current Medicare reimbursement system creates a financial disincentive that discourages hospitals from prescribing newer, more innovative medicines.
We must encourage congress to support legislation that supports innovation in the development of new antimicrobials. Legislators should reject the idea of a post-antimicrobial era in which there are few remaining treatment options for the most routine and basic infections and provide scientists with the tools to bring these much-needed medicines to patients.
Sign the petition and let congress know you support legislation that: