About one month after the announcement of McNeil Consumer Healthcare’s recall of children’s liquid pain and allergy medications (see back story, “J&J Voluntarily Recalls Certain OTC Products Because of Manufacturing Problems”), the US Food and Drug Administration testified before the US House Committee on Oversight and Government Reform about the issue. Representing FDA was Principal Deputy Commissioner Joshua M. Sharfstein.
On May 27, Sharfstein explained to the committee the agency’s quality concerns about McNeil, a division of Johnson & Johnson (J&J, New Brunswick, NJ).
“Over the last several years, FDA has had growing concerns about the quality of the company’s manufacturing process,” said Sharfstein. “These concerns have led to a number of unsatisfactory inspections and consumer recalls. FDA has inspected the company’s facilities with an increased frequency, and in February 2010, the Agency took the extraordinary step of convening a meeting with the management of the parent company, Johnson & Johnson, to express concern about a pattern of non-compliance.”
Some of the problems FDA identified before 2009 included laboratory controls, equipment-cleaning processes, and a failure to investigate identified problems. “The company generally fixed the specific problems, and the Agency inspected the firm regularly,” added Sharfstein. In May and June 2009, FDA found several violations of current good manufacturing practice (CGMP), including McNeil’s failure to meet its quality standard in an ingredient (microcrystalline cellulose) in its over-the-counter liquids, which led to a recall last summer of 8 million bottles of finished product.
In the fall of 2009, added Sharfstein in his testimony, McNeil received reports of a musty odor in certain products. The company did not fully investigate the reports or notify FDA of the reports, he said. The odor turned out to be a chemical called 2,4,6-tribromoanisole (TBA) and more recalls were made.
FDA issued McNeil a Warning Letter in January 2010 about the quality of its drugs and failure to adequately investigate and correct quality problems. Also in early 2010, FDA followed up on a report of the death of a 6-year-old child who died after taking several of the products in question that were manufactured by McNeil. No contamination in the products was discovered.
The agency expressed its concerns to J&J management at an unconventional meeting in February 2010. “The Agency learned that McNeil was taking several major steps to address these issues, including implementing management reporting structure changes, hiring new managers, and engaging a third party manufacturing consultant,” said Sharfstein.
In April 2010, FDA inspectors returned to one of the McNeil facilities in question—Fort Washington, Pennsylvania—but the facility was shut down before the inspection began due to manufacturing issues. Particulates were found in children’s liquid medications, which led to the major recall of Children’s Tylenol, Motrin, and Benadryl on Apr. 30, 2010.
Looking ahead, Sharfstein said FDA is “closely monitoring the implementation of a corrective action plan developed by McNeil that includes significant enhancements to its quality system, organizational changes, and senior management oversight. FDA will continue to investigate issues related to the Fort Washington facility including oversight related to renewal of manufacturing operations at that facility, to evaluate the facility’s suppliers, and evaluate the compliance of all other McNeil facilities.” He added that FDA is considering additional enforcement actions against the company.
Sharfstein detailed a few lessons learned from this case, including that FDA needs to more fully consider “the corporate structure” of a company and that it needs to review its recall process. “A range of activities are underway at the Agency to bring this vision to reality, including strengthening our criminal enforcement of FDA’s laws,” he concluded.
Tylenol Hearing to Take Place Today (blog post)