Lawmakers propose new antibiotics pathway to combat superbugs
- Sens. Michael Bennet (D-CO) and Orrin Hatch (R-UT) have introduced new legislation to make it easier for companies to get approval for antibiotics designed to treat antibiotic-resistant infections, RAPS reports.
- The Promise for Antibiotics and Therapeutics (PATH) Act is intended to create a 'limited population' pathway for antibiotics so that pharma companies can develop antibiotics targeted at very sick patients--without increasing the already severe problem of antibiotic resistance.
- Antibiotic approval has dropped dramatically since the mid-1980's, while the scourge of antibiotic-resistant infections has increased to the point of becoming a crisis.
The battle to conquer multi-drug resistant pathogens and the infections they cause is underway. Approximately 23,000 Americans die each year from antibiotic-resistant infections, leading government officials to declare this problem a public health challenge. In fact, in September, President Obama issued an Executive Order to combat antibiotic resistance. Companies on the front line of this effort include GSK, AstraZeneca, Cubist (which is in the process of being acquired by Merck) and others.
- Regulatory Affairs Professional Society Bill Seeks Creation of New Pathway for Antibiotic Drug Approvals