IDSA and Pew praise Senators for supporting official LPAD legislation
"We are writing today to applaud your leadership in supporting the creation of the Limited Population Antibacterial Drug approval pathway to expedite patient access to critically-needed antibiotics to treat serious or life-threatening infections for which there are currently few or no satisfactory treatment options," Coukell and Relman said.
Research dedicated to the production of new antibiotics has been on a decline, while the prevalence of drug-resistant bacteria continues to increase, making the need for stronger antibiotics urgent. Coukell and Relman commended the U.S. Senate Representatives on playing a key role in supporting the LPAD process, which will make the approval process for newly-developed vaccines much easier.
The LPAD pathway will keep the U.S. Food and Drug Administration approval guidelines for new drugs in-mind during the creation process, making for shorter and less expensive clinical trials before market approval. The LPAD pathway also allows for special labeling to keep it for limited use.
The methodology has not yet been officially approved. Coukell and Relman asked Bennet and Hatch to continue their support of the guidelines by approving the LPAD pathway.
"We urge you to enact legislation to create an LPAD pathway based on the principles in the attached document in order to make development more feasible for the antibiotics needed by most patients," Relman and Coukell said.