Many drug companies and health groups are backing a proposal by the
Infectious Diseases Society of America that streamlines the development of
antibiotics to treat serious bacterial infections.
Called the Limited Population Antibacterial Drug (LPAD) mechanism, the
legislative initiative would be included in the FDA Prescription Drug User Fee
Act reauthorization. The purpose of the LPAD would be to speed up the
development of antibiotics to treat serious infections that currently do not
have treatment options.
“We’re on the brink of a medical catastrophe,” Thomas
G. Slama, MD, IDSA president, said in a press release. “More and more
patients are succumbing to drug-resistant infections for which we have no good
treatment options, and yet the number of new antibacterial drugs being
developed is plummeting. We are engaged in ongoing discussion with
congressional leaders to help them appreciate just how serious this problem is,
and that the wide support illustrates that LPAD is a viable part of the
solution.”
Similar to the orphan drug program, the LPAD mechanism would allow
testing for new antibacterial agents to take place in smaller, shorter and less
expensive clinical trials. The LPAD would also assure that drugs approved would
be indicated for small, well-defined patients with serious, rarer infections,
not for more common infections.
Disclosures: Dr. Slama reports no relevant financial disclosures.