New path for antibiotic approvals?
Congress will consider a new drug approval pathway in an effort to
encourage development of critically needed, lifesaving antibiotics as
part of a strategy to address the public health crisis of antibiotic
resistance, the Infectious Diseases Society of America said. The society
proposed the new pathway to help streamline approval of new antibiotics
for serious infections where few or no treatment options currently
exist. The proposed mechanism would enable pharmaceutical companies to
study "Special Population Limited Medical Use" drugs in far
fewer patients than currently is required, more rapidly, and at
significantly less cost. The drugs would be reserved for use in specific
patient populations that lack other treatment options, and would include
warnings designed to encourage prudent use and slow the development of
resistance, according to the society.