Creation/Revision Date: September 12, 2014
September 12, 2014
Margaret A. Hamburg, M.D., Commissioner
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20903
Dear Dr. Hamburg:
The Renal Physicians Association (RPA) is the professional organization of nephrologists whose goals are to ensure optimal care under the highest standards of medical practice for patients with renal disease and related disorders. RPA acts as the national representative for physicians engaged in the study and management of patients with kidney disease. We are writing to address the shortage of peritoneal dialysis (PD) solution in the U.S.
RPA strongly believes that dialysis patients should have freedom of choice regarding their modality of dialysis care, and that every effort should be made to ensure that PD is among the available choices. Home dialysis modalities such as PD and home hemodialysis (HHD) not only are often cost-effective but also can facilitate improved patient quality of life and return to work, among other significant benefits. However, the current shortage of PD solution seems certain to impede access to PD for both incident and prevalent dialysis patients desiring this modality. 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.
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. 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.
Such flexibility is needed now. It is our understanding that there are manufacturing centers overseas with the capacity to partially offset the PD solution shortage, but that currently there is no FDA licensing and approval to make the additional supplies of PD solution available in this country. RPA strongly recommends that the FDA expedite review of the importation of additional PD solution from safe and reliable manufacturing facilities outside of the U.S. We recognize that importation of PD solution will not completely resolve the current shortage, but we also believe that minimizing disruptions in access to PD care is a critically important component of the effort to address the population health needs of patients with ESRD.
As always, RPA welcomes the opportunity to work collaboratively with FDA in its efforts to improve the quality of care provided to the nation’s kidney patients, and we stand ready as a resource to FDA in its future endeavors. Any questions or comments regarding this correspondence should be directed to RPA’s Director of Public Policy, Rob Blaser, at 301-468-3515, or by email at email@example.com.
Rebecca Schmidt, DO