Experts call for more FDA involvement, enforcement in glucose monitoring

WASHINGTON — In an era of ever-increasing introduction of inexpensive glucose monitors and test strips, experts at the Glucose Monitoring Consensus Conference called for increased surveillance by the Food and Drug Administration, pushing for enforcement of standards and penalties.

“Tomorrow, we might help bring to a tipping point that the FDA has been not as careful in this space as they have to be and it has consequences,” Daniel Einhorn, MD, MD, FACP, FACE, said during the conference convened by the American Association of Clinical Endocrinologists.

His peers agreed there is room for improvement.

Reporting measures

A focus for improvement during the discussion was post-market surveillance and measures taken by both the FDA and manufacturers to report adverse events.

“There is definitely high consensus that the FDA could do better in post-market surveillance,” Pauline M. Camacho, MD, FACE, who headed the patient and lay organization discussion, said. “There’s a problem attributing responsibility for adverse events.”

She pointed to the moment of adverse event occurrence and the likelihood that the patient is unaware that the inaccuracies in his or her blood glucose reading are due to the equipment and not a true spike or dip in glucose.

“The FDA is to be commended for their recognition of the need for an independent entity to perform ongoing pre- and post-marketing testing of blood glucose monitor devices. This could be funded by industry based on percent of total strip sales,” Camacho said.

She suggested “aggressive use of media” when a product poses harm to a patient group due to its inaccuracy.

Eric A. Orzeck, MD, FACP, FACE, who moderated the societies’ panel said, “There should be a standardization so the reports are going to have the same information across the different modalities.”

Einhorn suggested that the need for enforcement of these reports reaches the ongoing differences in manufacturers.

“The ethical companies provide the reports and the unethical ones do not,” Einhorn said.

Standards set, enforced

Additionally, experts lamented the lack of high standards set and enforced by the administration.

“Studies suggest that 25% of the meters on the market today do not meet the ISO 2003 standards and about 50% do not meet the 2013 standards,” Howard M. LAndo, MD, FACP, FACE, said. “The FDA only requires that all of the meters meet 1976 mandated standards. So, even though technology has changed, those are the standards you have to meet to bring a meter to market.”

Camacho said standards should be enforced.

“The FDA should rigorously apply existing enforcement options and expeditiously prohibit the sale and marketing of devices which do not meet the ongoing evaluation of quality, including embargoing products made in other countries,” Camacho said.

Einhorn returned to the idea of ethics among manufacturers.

“The industry has made me aware of the inherent unfairness of how the playing field is right now,” Einhorn said. “It’s possible to be a company who is less ethical but still make it in the market once you’re cleared.”

He said the increasingly onerous restrictions are putting “extraordinary pressures” on strip manufacturers.

“The FDA really should be pressed to fulfill its mandate for safety, including that the initial data and in the ongoing surveillance. … There really is no good mechanism to do that,” Einhorn said. “I’m concerned to be losing ethical companies and only having unethical cheap ones be present.”

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