WASHINGTON Sen. Tom Harkin, D-Iowa, on Monday penned a letter addressing Food and Drug Administration commissioner Margaret Hamburg following the recall of 40 varieties of children’s and infants’ formulations of Tylenol, Motrin, Zyrtec and Benadryl by Johnson & Johnson’s McNeil Consumer Healthcare.
“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.”
Harkin, who is chairman of the Senate health, education, labor and pensions committee that has jurisdiction over the FDA, posed questions regarding the recall, events leading up to it and consumer complaints.
Harkin was particularly interested in the voluntary recall process, asking if the FDA had initiated the request for a voluntary recall, and had they been denied that request, would the agency have had the authority to mandate a recall.
Harkin requested FDA respond to his list of questions by June 11.