Lack of FDA Post-Marketing Oversight on Meter Accuracy Puts Diabetes Patients’ Lives at Risk
The Diabetes Patient Advocacy Coalition (DPAC) is an alliance of people with diabetes, caregivers, patient advocates, health professionals, disease organizations and companies working collaboratively to promote and support public policy initiatives to improve the health of people with diabetes. DPAC’s guiding principles focus on 3 key areas:
- Safety (enforce established safety standards on devices, medications and practices for diabetes care
- Quality (advance the standards of care for diabetes management)
- Access (access to health care and quality diabetes products for all 29M Americans with diabetes)
Given the rising costs of diabetes in America, it is critical that Americans have access to ALL components of diabetes training and treatment programs to prevent costly hospitalizations and complications. Yet many patients are facing increasing cost burdens for their diabetes treatment regimens and are choosing to use lower cost self-monitoring blood glucose testing systems (SMBG). Medicare has implemented the competitive bidding program that severely limits patient choice and access for SMBG and has led to a plethora of low-cost blood glucose systems that Medicare patients are forced to use.
Various studies have shown the importance of SMBG in a patient’s diabetes disease management program and is even more critical for those patients that use insulin, as it is used for dosage calculation and prevention/detection of hypoglycemia and hyperglycemia. Inaccurate glucose information can lead to severe consequences. Patients who use continuous glucose monitoring (CGM) also are impacted by inaccurate blood glucose monitoring systems as they are required to calibrate CGM devices through SMBG systems and dose insulin based on their CGM readings.
After a SMBG is approved for use by the FDA, there is currently no systematic follow-up process that monitors for ongoing product quality and compliance with international accuracy standards. The Diabetes Technology Society established a surveillance program for SMBG in May 2014. This surveillance program assessed the accuracy of 18 SMBG marketed in the USA and representing approximately 90% of the commercially available systems. Twelve systems failed to meet the accuracy standards, yet these products are still on the market and 2 of them (Prodigy, Embrace) account for over 40% of the Medicare market.
Even though the FDA was engaged in the development of the protocol for the SMBG surveillance program and was listed as co-authors of the summary paper, it is not clear why the FDA has not more aggressively regulated the market for SMBG systems. For 510k approval, the FDA relies on data generated and submitted by the manufacturer and does not independently evaluate the device. Once the product is approved and in the market, the FDA has limited resources to conduct manufacturing inspections, especially overseas. Many of the manufacturers of the low-cost brands also do not provide medical device reports (MDRs), which makes it difficult for the FDA to track post-market performance.
While DPAC applauds cost-containment efforts for patients, we do not advocate such measures at the expense of patient safety and poor patient outcomes. We support efforts that require the FDA to more rigorously monitor the post-market performance of self-monitoring blood glucose systems and provide black-box warning labels for those systems that do not meet international accuracy standards.