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Drug companies, health groups back IDSA antibiotic proposal
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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.
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Janet A. Englund, MD
The Pediatric Infectious Diseases Society strongly endorses the IDSA proposal streamlining development processes for new antibiotics. As rates of antibiotic resistance rise and the availability of new therapeutics decreases, we have great concerns for our ability to treat our vulnerable patients and welcome this new proposal.
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