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FDA Would Do Better to Regulate Pre-Market Quality Control of Over-the-Counter Drugs

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When the Food and Drug Administration recalled more than 40 varieties of liquid pediatric Tylenol, Motrin, Benadryl, and Zyrtec last month they advised consumers to use drugstore “house brands” of the medications instead. But now, Perrigo, a company based in Michigan that supplies drugstores with “house” brands, has received a warning letter from the FDA about significant manufacturing violations.

The problems cited in the FDA warning letter included ibuprofen tablets contaminated with metal shavings. While the problems did not specifically concern children’s medications, the deficiencies in the manufacturing process raise important questions about why drug makers are shipping off medications to drugstores that they know are defective and potentially dangerous to consumers.

In light of the recent Johnson & Johnson Congressional hearings, the FDA should take a hard look at premarket manufacturing processes. The House Committee on Oversight and Government Reform recently suggested that criminal penalties be levied against Johnson & Johnson for their failures in abiding by manufacturing and quality-control procedures. However, the FDA would do better to ensure premarket quality of medications—both name brand and generic—before the products slip down another unknowing consumer throat.