WASHINGTON (Reuters) - Another lawmaker asked regulators on Friday for information about Johnson & Johnson’s recall of Children’s Tylenol and other over-the-counter pediatric medicines.
Democratic Representative Rosa DeLauro sent a letter to the Food and Drug Administration asking questions about how the agency can respond to recalls and quality control lapses.
“I am concerned that the agency does not possess the authority to take appropriate action to address potentially criminal behavior by a corporation,” DeLauro wrote in the letter to FDA Commissioner Margaret Hamburg.
She asked if the FDA would recommend that the Justice Department impose fines or pursue criminal charges “if the FDA investigation determines that criminal behavior may have been involved.”
DeLauro chairs a House of Representatives subcommittee that funds the FDA. She has frequently criticized the FDA’s response to dangerous food and medicines.
FDA officials on Tuesday urged parents to seek generic alternatives to the recalled medicines and said they were weighing possible further regulatory action.
Officials at the FDA and Johnson & Johnson could not immediately be reached for comment.
On Thursday, the House Committee on Oversight and Government Reform said it opened an investigation into J&J’s recall.
The company recalled 40 widely used children’s pain and allergy medications, saying some may have a higher concentration of their active ingredients, while others may be contaminated. J&J has had four recalls in the past year of over-the-counter medicines.
In an FDA report issued on Tuesday, inspectors said they found thick dust, grime and contaminated ingredients at the J&J plant that produces Children’s Tylenol and dozens of other products recalled last week.
DeLauro, in her letter, said the company’s “disregard” for manufacturing standards was “both unnerving and unethical.”
“The corporate oversight observed at this facility appears to be symptomatic of reckless behavior that is clearly unacceptable,” she wrote.
J&J has called the manufacturing problems unacceptable and vowed to fix them. The company has suspended production at the Pennsylvania plant where the recalled children’s products are made.
DeLauro asked the FDA if the agency’s power to respond to recalls needed strengthening. The agency does not have authority to mandate a recall of any drugs, she said.
She also asked if the FDA should “require facilities to more effectively monitor trends such as consumer complaints.”
Reporting by Lisa Richwine; editing by Andre Grenon and Carol Bishopric