FDA to keep a close eye on McNeil operations

WASHINGTON According to prepared testimony immediately posted online before members of the Committee on Oversight and Government Reform convened its “Johnson & Johnson Recall of Children’s Tylenol and other Children’s Medicines” hearing Thursday morning, J&J may be under scrutiny for more than the 40 varieties of over-the-counter infant’s and children’s liquid medicines recalled April 30.

“Just last night, the Committee obtained from the [Food and Drug Administration] even more disturbing information,” committee chairman Rep. Edolphus Towns, D-N.Y., stated as part of his opening remarks. “According to an FDA document, McNeil knew there was a potential problem with one of its Motrin products that was on the market in 2008, but rather than issue a public recall, McNeil allegedly sent contractors out to stores to buy the product back and told the stores 'not to mention' a recall,” Towns wrote. “After the FDA confronted McNeil about this, McNeil announced a recall of the affected products.”

Regarding the latest recall, Colleen Goggins, J&J worldwide chairman for consumer group, expressed the company’s disappointment in the factors leading up to the recall.

“Across our organization, we believe our first responsibility is to the doctors, nurses, and patients, to mothers and fathers, and all others who use our products and services,” Goggins noted has part of her prepared testimony. “In this instance, we have not lived up to that responsibility, and the recall is therefore a disappointment to our chairman Bill Weldon, to me personally, and to the thousands of employees in the Johnson & Johnson family of companies.

“Johnson & Johnson embraces the work of this Committee, and we hope that today’s hearing will be an important step in furthering public understanding of the recall,” she added, stating that the quality and process issues at McNeil that led to the recall “are unacceptable.”

Goggins also stressed before the committee that the health risks associated with the recalled products were remote. No serious adverse events associated with recalled products have been reported to date; no raw materials that tested positive for objectionable bacteria were ever used in the manufacture of McNeil’s pediatric products; and McNeil had rejected the products that it found had excess active ingredient before those products reached the supply chain.

Despite the public apologies issued by J&J, both legislative and regulatory officials have been taking a hard line against the company.

“Over the last several years, FDA has had growing concerns about the quality of [McNeil Consumer Healthcare’s] manufacturing process,” remarked Joshua Sharfstein, FDA principal deputy commissioner, as part of his prepared remarks. “These concerns have led to a number of unsatisfactory inspections and consumer recalls,” he continued. “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 noncompliance.”

The meeting took place Feb. 19, Sharfstein testified, and included the president of McNeil, J&J’s group chairman and “a number of quality assurance executives from both companies.”

Sharfstein testified that “FDA requested that senior officials from Johnson & Johnson attend the meeting so they would be on notice regarding FDA’s rising concerns about whether McNeil’s corporate culture supported a robust quality system to ensure the purity, potency and safety of its products.”

Sharfstein also testified that of all the good manufacturing practices violations the agency identified at McNeil’s Fort Washington, Pa., plant, that the “pubic health risk from these quality problems is low.” The FDA did not find evidence that McNeil used raw materials that tested positive for bacterial contamination. And while there was a potential for higher concentrations of Tylenol per dropper, “none of the final products released for sale tested with high levels [of active ingredient].”

Going forward, FDA plans to keep a close eye on McNeil operations, Sharfstein testified. What’s more, the FDA will take corporate culture into account in future reviews of any company. “One lesson to be drawn from the McNeil story is that it is important for the Agency to even more fully consider the corporate structure when investigating and enforcing the law,” Sharfstein testified. “[The] FDA will be developing new procedures to use what we learn at one facility in guiding our inspections of other facilities run by the same company.”