HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Tuesday, July 20, 2010

Proposed BIll Gives FDA Mandatory Recall Powers

Hat tip to Pharmalot for highlighting a proposed bill to give the FDA mandatory recall powers:

In light of the Johnson & Johnson recall scandal, the House Committee on Oversight & Government Reform has, as promised, introduced a bill to give the FDA mandatory recall powers. The move comes after Ed Towns decried the way J&J’s McNeil Consumer Healthcare unit responded to repeated quality control problems that led to the recall of tens of millions of over-the-counter pediatric meds (back story here, here and here).

Under the legislation, which amends the Federal Food, Drug and Cosmetic Act, the FDA would have the authority to demand a recall when there is an indication that a drug has been adulterated, misbranded, or exposure to a drug may cause serious adverse health consequences or death to humans and animals (here is the bill). The J&J products, which the healthcare giant is scrambling to produce elsewhere while its Fort Washington, Pa., plant is shutdown indefinitely, were found to have a musty smell, metallic flecks or too much active ingredient. Towns accused the McNeil unit of conducting a phantom recall in hopes that regulators and consumers would not be alerted to the problems.

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