U.S. Senator Seeks Answers on Infant Tylenol Recall, FDA Drug Authority

A U.S. Senator is probing into a series of recalls by Johnson & Johnson and its subsidiaries, including a recent children’s medication recall, asking whether the FDA needs more authority to force drug makers to recall potentially dangerous products. 

Iowa Senator Tom Harkin, chairman of the powerful Senate Committee on Health, Education, Labor and Pensions, wrote a letter (pdf) to Margaret Hamburg, commissioner of the FDA on Monday, asking pointed questions on whether Johnson & Johnson and its subsidiaries dragged their feet on recalling potentially contaminated drugs. The letter comes just before company officials are set to face U.S. lawmakers at a hearing in the House of Representatives on Thursday.

Harkin said he was deeply concerned over a recall this month of nearly 40 liquid children’s medications by Johnson & Johnson subsidiary, McNeil Consumer Healthcare, including infant Tylenol, Benadryl, and Motrin. The products were recalled due to particulate contamination and irregularities in potency and resulted in a warning letter from FDA regarding quality control issues at a Johnson & Johnson manufacturing plant in Ft. Washington, Pennsylvania.

“I am interested in ensuring that, as a public health agency whose mission is to protect the American public, you have sufficient authority to prevent and respond to contamination of the drug supply,” Sen. Harkin wrote. “I am especially concerned because so many of the drugs at issue in this recall were intended for infants and children.”

In his letter, Harkin asked whether FDA requested the most recent recall and if McNeil had resisted the request. He also asks whether FDA could have forced the company to recall the products if it resisted, and whether FDA needs “additional authority to respond to this sort of situation.”

Although no problems have been reported in association with the recalled medications and the risk of serious medical problems is low, parents throughout the United States and 11 other countries have been urged to stop using the medications. In addition to the possibility of contamination by organisms, some of the products may have higher concentrations of active ingredients than are specified, others may contain inactive ingredients that do not meet internal testing requirements and some may contain tiny particles, according to the FDA.

Harkin pointed out that the recall was the latest in a series of problems with McNeil Consumer Healthcare products, including a September 2009 recall due to bacteria contamination; an October 2009 advisory not to use some McNeil drugs after they were stolen from a cargo terminal in Jacksonville, Florida; and a December 2009 recall of Tylenol due to a musty odor caused by contaminants from wood pallets.