GAO Shines Spotlight on Dearth of Antibacterial and Antifungal Treatments

There aren't enough drugs under development to treat antibacterial and antifungal infections in patients with limited treatment options, even though the FDA offers a particular pathway to help expedite such candidates, the Government Accountability Office (GAO) reported.

Thus far, economics have been an issue. Since the population who needs these drugs is very limited, drug companies can’t recoup their high drug development costs through sales, which has resulted in few drugmakers willing to fund development of such candidates, GAO found.

The 21st Century Cures Act of 2016 established the limited population approval pathway for antibacterial and antifungal drugs (LPAD) to help facilitate the approval of antibacterials and antifungals for serious or life-threatening infections that affect a limited group of patients and are not adequately addressed by available therapy.

But since 2016, drugmakers only requested the pathway for four drugs, two of which were approved.