Harkin Questions FDA in Wake of Johnson & Johnson Children’s Drug Recall

WASHINGTON, D.C. – Senator Tom Harkin (D-IA) today sent a letter to Food and Drug Administration (FDA) Commissioner Margaret Hamburg, M.D., following the recall of 40 varieties of childrens’ and infants’ formulations of Tylenol, Motrin, Zyrtec and Benadryl by Johnson & Johnson’s McNeil Consumer Healthcare.  Harkin, who is Chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee that has jurisdiction over the FDA, posed questions regarding the recall, events leading up to it and consumer complaints.  Johnson & Johnson has had problems associated with these products over the past two years.  Harkin also asked the agency if additional regulatory action is needed to prevent further recalls.

“I commend you for FDA’s leadership in responding to this crisis, both in terms of your outreach to the public and your increased regulatory activity,” Harkin wrote.  “However, 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.  I am especially concerned because so many of the drugs at issue in this recall were intended for infants and children.”

The full text of the letter can be found here.