The Renal Physicians Association has recommended that the U.S. Food and Drug Administration expedite review of the importation of additional peritoneal solution from manufacturing facilities outside of the U.S. to address Baxter Healthcare's shortage of the sterile solutions in the United States.
"RPA fully supports the FDA’s mission to protect the nation’s public health by assuring the safety, efficacy, and security of products such as PD solution, and we appreciate the attention that FDA devotes to safety issues affecting the care delivered to populations of patients such as those on dialysis," the professional organization of nephrologists said in a letter to the FDA. "We do however also believe that in times of need such as when shortages of drugs and medical products affect patient care and quality of life, regulatory flexibility is appropriate."
The RPA warned that the shortage of solutions would affect dialysis patients' access to modality choices. "The current shortage of PD solution seems certain to impede access to PD for both incident and prevalent dialysis patients desiring this modality," the RPA wrote. "This is unfortunate in that there have been distinct increases in the number of home dialysis patients (both on PD and HHD) in the last several years, and it would be a significant step backward for that momentum to be lost. "
The National Renal Administrators Association sent a similar letter to the agency Sept. 5.
Baxter reported in August that it was experiencing supply constraints for peritoneal dialysis solutions and instituted a process to temporarily limit the number of new peritoneal dialysis patient referrals across their entire base of customers. The company said they recommend that health care professionals prioritize new PD patient starts based on medical necessity where other therapy options may be contraindicated.
Read the full RPA letter here.