New Senate Legislation May Impede Voluntary Self-Enforcement by Companies Regulated by FDA

By Peter M. Jaensch –

United States Senator Charles Schumer (D-NY) recently introduced legislation that is intended to prevent sales of recalled biologics, drugs, medical devices, infant formula, and foods.  However, if that legislation is enacted it  may actually dissuade companies from undertaking voluntary recalls.

On February 14, 2011, Sen. Schumer introduced S. 330, the “Consumer Recall Protection Act of 2011,” which, if enacted, would prohibit sales “to a consumer of a covered product that is subject to a recall,” except  where the “defect was remedied” and the seller notifies the consumer of the “recall, defect, and remedy” prior to sale.  Among other products, the bill covers “[f]ood, drugs, devices, and cosmetics” as defined in the FDC Act.  The bill defines various triggers for when a product is considered to be subject to a recall.  Although specific triggers are provided for medical devices and infant formula, other products are considered subject to a recall whenever there is a “recall of the . . . product by the manufacturer or distributor in response to an advisory or other alert issued by the Commissioner of Food and Drugs that advises consumers to avoid the . . . product.”

The bill is at best ambiguous.  For example, what constitutes an “alert” or an “advisory,” and when is a recall considered to have begun “in response” to such notifications? Moreover, if enacted, S. 330 may actually reduce self-enforcement by companies.  As currently written, S.330 would appear to apply even when there is not a safety issue associated with the “recall.”  Under these and other circumstances, a manufacturer might well think twice about commencing a recall at all if the manufacturer will be prohibited from selling “recalled” products.

There is one particularly interesting bureaucratic feature in the legislation.  Even though the trigger for the prohibition of sales is largely tied to actions of the FDA, that agency would not enforce the legislation.  Instead, Sen. Schumer proposes that the Federal Trade Commission would enforce the legislation if it is enacted.