A congressional committee has launched an investigation into the problems that led to a massive recall of children's and infants' Tylenol and other widely used over-the-counter pediatric medicines, with lawmakers pledging to scrutinize the performances of both the drugmaker and federal regulators.
Reps. Edolphus Towns (D-N.Y.) and Darrell Issa (R-Calif.), the leaders of the House Committee on Oversight and Government Reform, said in a joint statement that they are "deeply concerned" about the recall, which affects an estimated 70 percent of the market for over-the-counter pediatric liquid medicines. It involves such brand names as Motrin, Benadryl and Zyrtec, in addition to Tylenol.
The pair pledged to ask "tough questions about the conditions of the manufacturing plant and controls put in place by the drug company's management, and about whether FDA's inspection and recall procedures were sufficient." They expect to schedule hearings in the coming weeks, they said.
The investigation comes a day after the Food and Drug Administration released documents compiled by federal inspectors who catalogued widespread quality control problems at the Pennsylvania facility where the recalled medicines were manufactured by McNeil Consumer Healthcare, a division of Johnson & Johnson.
At the McNeil plant, the FDA identified defects in quality-control methods and manufacturing processes, including a failure to track customer complaints and spot trends that may signal systemic problems, a lack of written procedures and a failure to adequately train employees.
The FDA began what it termed a 10-day "routine inspection" of the McNeil facility on April 19. On the last day of the inspection, last Friday, McNeil announced a voluntary recall of 43 types of Tylenol and other best-selling brand names made at the facility. It also suspended operations at the plant indefinitely.
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Federal investigators found that raw materials had "known contamination" with unspecified bacteria and "were approved for use to manufacture several finished lots of Children's and Infant's Tylenol drug products."
FDA officials said Tuesday they could not identify the bacteria.
But McNeil said that the raw materials it used for finished products were tested and found free of contamination.
Towns and Issa said they hope their investigation will clarify the conflicting accounts.
McNeil has said some of the recalled medicines may have a higher amount of active ingredient, others may contain inactive ingredients that do not meet internal standards, and still others may contain black particles.
FDA inspectors said that McNeil first learned it had a problem with black particles in some of the medications when it began receiving consumer complaints last June but that the company failed to fully investigate the problem and correct it. McNeil received 46 complaints between June and last month.
Federal officials said no health problems have been linked to the recalled medicines, but that their investigation continues. They have advised parents and caregivers to stop using the recalled medicines and to switch to generic versions, which are not affected by the recall. Impossible made possible
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