Johnson & Johnson's recent recall of over 40 liquid kids medicines due to bacterial contamination is prompting a key senator to probe whether the agency charged with overseeing drug safety has enough power to do the job.
Senator Tom Harkin, D-IA, is asking the Food and Drug Administration for more information about how well the company cooperated with the kids' meds recall and several other incidents over the past year. But he takes it a step further.
"I commend you for FDA's leadership in responding to this crisis," the letter to FDA Chief Peggy Hamburg says. "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."
FDA initiated the recall after investigating conditions at a Pennsylvania plant of J&J's consumer health division, McNeill Consumer Healthcare. At the time of the recall, FDA said there were no safety concerns with the medicines.
Still, it warned consumers not to use the recalled medicines, and suggested that parents pick up generic versions of those products instead.
Harkin says the kids' meds recall is "only the most recent in a series of disturbing events associated with products sold by the company since September 2009."
Specifically, he points out that consumer complaints about a "musty odor" associated with adult medicines last year garnered consumer complaints for over a year before J&J took action to recall the products.
These two incidents may indicate a pattern of lax oversight, NPR's Scott Hensley told Morning Edition Host Renee Montagne earlier this month.
Harkin wants the FDA to provide more details about what it plans to do next with J&J, and whether the agency needs more power over pharmaceutical ingredients and drug recalls in general, spokeswoman Kate Cyrul tells Shots.
It's too soon to say whether the senator will seek hearings or legislation, she added.
J&J/McNeill has not yet returned a request for comment.