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Mallinckrodt cited for omitting risk information from exhibit booth panels

Pharma Compliance Alert, November 8, 2006

Mallinckrodt must change exhibit booth panels promoting MD-Gastroview and OptiMARK, because the panels lack any information about the drugs' risks, according to a recent FDA warning letter.

The panels for MD-Gastroview and OptiMARK entitled "Break Through to a Brighter View" and "The Power to Illuminate," respectively, are misleading because they present effectiveness claims withoug revealing any risk information related to the drugs, the letter says.

MD-Gastroview and OptiMARK are imaging contrast agents used in gastrointestinal and liver scans, respectively. FDA-approved labeling for both drugs warns that the agents can sometimes cause a "shock-like state."

The only allusion to the drugs' risks is the direction to "see representatives in booth for full prescribing information" written inconspicuously in the lower left corner of the booth panels. The panel for OptiMARK highlights the drug's "excellent safety profile," a claim that FDA says is misleading.

FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) has warned the company about its exhibit booths before in letters in 2004 and earlier this year citing similar violations, but for different drugs.

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