New Bill Seeks to Limit the Way Manufacturers Handle Recalls

Feb 25, 2011   

Last week, United States Senator Charles Schumer (D-NY) introduced a bill aimed at limiting the options that manufacturers may pursue in the event of a product recall.  Found here, the Consumer Recall Protection Act states that “. . . a person may not sell to a consumer any covered product that is subject to a recall.”  As written, the Act will apply to a variety of products, including food, drugs, cosmetics and devices, all covered by the Food, Drug, and Cosmetic Act (FD&C).  If enacted, the Consumer Recall Protection Act will prohibit manufacturers from selling recalled products to consumers until the defect prompting the recall is remedied. 

The Bill may have come as a response to the recent controversies raised by Johnson & Johnson’s “phantom recall” efforts.  As previously reported, the handling of several recalls by J&J has led to scrutiny of the current recall process by the FDA and Congress.  After years of concern regarding the company’s manufacturing and responsiveness to FDA warnings, the massive recall of Children’s Tylenol in 2010 led Congress to probe the effectiveness of the FDA’s regulation of drug manufacturing.  During a recent hearing before the House, the FDA expressed its concern regarding J+J and the company’s efforts to postpone recalling its products.  In what is known as a “phantom recall,” J+J hired contractors to go into stores and purchase its products rather than conducting a widespread and highly-public voluntary recall.   

In addition to combating the “phantom recall,” recent legislative efforts have focused on reforming the current voluntary recall process for drug products.  Because the current drug recall scheme is voluntary, the FDA is often able to prompt manufacturers into initiating recalls after alerting the public of the possible dangers associated with the products at issue.  While the recent Food Safety Modernization Act, discussed here, granted authority to the FDA to issue mandatory recalls in certain circumstances, the FDA does not currently have the power to initiate recalls of drugs.  However, the voluntary recall process for drug products may soon come to an end.  As recently reported, new legislation has been introduced in the House that focuses on reforming the FDA’s ability to oversee and enforce drug safety.  The bill, known as the Drug Safety Modernization Act, largely mirrors the recent food safety legislation and contains provisions giving the FDA mandatory recall authority over drug products.  

While it appears that Congress is scrambling to restore public confidence in the FDA’s ability to keep consumers safe, the potential effectiveness of the newly proposed Consumer Recall Protection Act is questionable.  Although the bill may largely be a response to J+J’s phantom recall efforts, the Act will only prevent companies from selling products to consumers once a recall has already been initiated.  Because the Act would only apply once a recall has been initiated, it would not have prevented the phantom recall situation that J+J engaged in.