DexCom Pledges to Cooperate With FDA on Improved Warning Labels for Devices
San Diego’s DexCom (NASDAQ: DXCM) says it intends to cooperate with changes sought by the U.S. Food and Drug Administration in the way it labels certain biomedical devices for monitoring blood sugar levels.
In a statement yesterday, DexCom says it received an FDA warning letter alleging that the company had failed to adequately disclose that its sensor wires sometimes fracture, leaving wire splinters under the skin of some users. The FDA, which posted the warning letter on its website yesterday, recommends that DexCom make some specific changes to the company’s warning and precaution statements in its product labeling.
DexCom says its own interpretation of the relevant regulations had led the company to conclude that such events did not require such disclosures. Nevertheless, DexCom says the FDA letter triggered a torrent of investor inquiries, prompting DexCom CEO Terrence Gregg to hold a conference call with analysts and investors late yesterday. After plunging at the opening bell, DexCom shares regained altitude to close yesterday at $9.80 a share.
In its statement, the company says, “DexCom does not expect this matter will have any impact on production or on future product approvals.” DexCom also expects to respond to the FDA’s concerns “within the time frame set forth in the warning letter.”
DexCom Chief Executive Terrence Gregg downplayed the warning letter in the conference call, according to The San Diego Union-Tribune. Gregg says the labels on two specific products, DexCom’s Seven and Seven Plus monitoring systems, already carry labeling sought by the FDA that warns the products are not approved for use by children, adolescents, pregnant women or patients on dialysis. Gregg says DexCom first reported the issue involving splintered sensor wires to regulators four years ago, but this was the first time the agency had sent him a warning letter on the issue.
Gregg says he didn’t see the FDA warning letter as “a major issue” for the company.