Reps. introduce bill for antibiotic approval pathway, breakpoints

A bipartisan group of representatives introduced in the U.S. House of Representatives a bill that would create an accelerated approval pathway for antibiotics and antifungals for use in limited populations and would update the criteria that HHS uses to determine breakpoints for drugs. Under the Antibiotic Development to Advance Patient Treatment (ADAPT) Act, FDA could approve antibiotics and antifungals for limited populations based on a smaller number of patients or alternative endpoints, as well as data from Phase II trials or pharmacologic or pathophysiologic data. The Infectious Diseases Society of America (IDSA) first proposed the approval pathway. Though new legislative authority is not needed to implement the pathway, stakeholders have said congressional enactment of the regulatory framework could be valuable (see BioCentury Extra, July 31).

IDSA expressed support for ADAPT but recommended amending the bill to include a logo requirement to clearly mark drugs approved under the pathway. Currently, a label would only include a statement noting the drug is intended for use in a limited population. In a letter to the sponsors, the Pew Charitable Trusts also recommended legislators "strengthen" labeling requirements for drugs approved under the proposed pathway and limit the pathway to bacterial infections (see BioCentury, Jan. 28). ...