FDA Policy/General

FDA Cites QOL Medical for Misleading Promotion of Sucraid

FDA has issued an untitled letter to QOL Medical, alleging that promotional emails for its rare-disease therapy Sucraid (sacrosidase) Oral Solution were false or misleading because they overstated the drug's benefits and omitted important risk information.

In the just-posted letter, CDER’s Office of Prescription Drug Promotion (OPDP) said it reviewed two marketing emails submitted by the company and concluded that the materials misbranded Sucraid, resulting in distribution of the drug in violation of the Federal Food, Drug, and Cosmetic Act.

The agency took issue with promotional statements including "Try Sucraid," "Do you have patients suffering with unresolved IBS-like symptoms?" and "Could it be CSID?" FDA said those messages created the misleading impression that Sucraid could be used to treat irritable bowel syndrome (IBS) because some IBS symptoms overlap with those of congenital sucrase-isomaltase deficiency (CSID).

According to FDA, Sucraid's approved indication is considerably narrower. The enzyme replacement therapy is approved for treating sucrase deficiency, a component of CSID, in adult and pediatric patients five months of age and older. The agency said the emails implied that Sucraid could address all contributing factors of CSID and failed to adequately communicate the limits of the drug's indication.

FDA also criticized the emails for omitting material safety information. The agency noted that the promotional materials failed to disclose warnings regarding severe hypersensitivity reactions, including wheezing, rash and itching, and did not adequately communicate that the product contains papain, which has been associated with allergic reactions.

In addition, OPDP said the emails omitted precautionary information concerning increased blood glucose levels in patients with diabetes and the need for dietary starch restriction in some patients because Sucraid does not replace the digestive enzyme isomaltase.

The agency further argued that the presentation of risk information minimized the seriousness of certain risks by placing adverse reaction information ahead of more significant precautions, potentially leading readers to underestimate the product's safety concerns.

FDA requested that QOL Medical immediately address the alleged violations, including discontinuing misleading promotional communications.

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