McNeil Consumer Healthcare adds executive posts for quality assurance in its response to FDA's warning about a problem with packaging materials that led to a massive recall of OTC products.

The Johnson & Johnson subsidiary could provide a model for industry in the upper-management additions as well as in the overhaul of its standard operating procedures relating to quality, consumer complaint response and material handling. The firm made the changes after recalling about 500 lots of product, including Tylenol and Motrin stock-keeping units, in potentially contaminated packaging.

In a Feb. 5 ¹ letter to FDA, posted March 16, McNeil responds to a previous agency warning and lays out a series of organizational and procedural reforms bringing operations more in line with FDA expectations for pharmaceutical manufacturers.

The letter details organizational changes McNeil made to address quality control, including appointing Veronica Cruz to the new post of quality assurance VP for OTCs. Cruz moved to McNeil from VP of North America quality operations for J&J's Global Pharmaceutical Supply Group.

Cruz will report to Sam Jiwrajka, who was named to the new post of head of quality for the J&J Group of Consumer Companies.

Organizationally, McNeil is seeking increased support from J&J's consumer quality resources. Quarterly quality system reviews will include the McNeil management board as well as J&J participants.

As a member of the McNeil management board, which is accountable for product quality and regulatory compliance, Cruz will oversee an assessment of the McNeil quality system, to be completed by April.

A resulting plan for strengthening complaint vigilance, corrective and protective actions and quality systems will be shared with FDA, McNeil says.

Emphasis On Executive Oversight

Food and drug law expert Ralph Hall said McNeil's actions are unsurprising and appropriate, given FDA's expectation that senior managers have oversight of and accountability for quality assurance.

"I think this is just, among other things, a reminder to everyone of the critical role that executives, in FDA's mind - I think, correctly - play in quality system matters," said Hall, a distinguished visiting professor at the University of Minnesota Law School and counsel to Indianapolis firm Baker & Daniels.

The shifts within J&J/McNeil are typical of a large corporation's attempts to strike the right balance to ensure proper quality oversight, he added.

"There's always this tension between centralized control and management, versus holding those on the front lines accountable and responsible for what's happening within their sphere of influence. And you see, I think, here Johnson & Johnson is tweaking that balance."

Sniffing Out Trends

FDA's Jan. 15 warning letter noted the firm's failure to investigate thoroughly consumer complaints of nausea, stomach pain and other adverse events allegedly linked to a musty, moldy odor from a chemical breakdown on a supplier's wooden pallets that contaminated some product containers (² Also see "McNeil Expands Tylenol Recall As FDA Criticizes Firm's Response To AERs" - Pink Sheet, 18 January, 2010.).

In response, McNeil President Peter Luther says the firm has refined its complaint categories to "increase our ability to identify signals and trends faster, and to take action more effectively."

The revised strategy will track AE trends across product lines and lots through its "central complaint vigilance quarterly process," which currently reviews complaints, beginning in April.

Scenarios warranting an FDA field alert from McNeil - in which bacteriological contamination of a drug cannot be ruled out - also have been expanded. This "will likely result in more frequent communications with FDA," the company says.

McNeil offers in a separate Feb. 5 ³ letter an expanded response to the Form 483 report on FDA's inspection of the firm's Las Piedras, Puerto Rico, facility.

"We are confident that this corrective action plan provides the approach necessary to identify and implement systemic actions that will improve and enhance our quality processes and systems while addressing the concerns raised by the FDA," Luther writes.

Lessons From The Wine Industry

McNeil will require all material suppliers to certify their use of heat-treated pallets free of 2,4,6-tribromophenol, a wood preservative that can break down into 2,4,6-tribromoanisole under certain environmental conditions and cause contact contamination.

Contamination from treated wooden pallets previously spurred the wine industry to develop preventive measures, according to pharmaceutical supply chain consortium Rx-360.

In a March 13 release, the nonprofit group notes strategic preventive measures such as periodic inspections of third-party facilities - including testing for TBA and other halogenated anisole compounds in the atmosphere, water supply and infrastructure - sanitation of infrastructure to limit colonization of microbes, and eliminating the use of cleaners with chlorine and bromine.

While McNeil says it appears TBA contaminated the packaging but not the OTCs within, Rx-360 says things could have been worse.

"Since the plastic bottles were transported and then subsequently stored on tainted pallets, ample opportunity existed for the TBA contaminant to absorb into the containers," the consortium says.

- Dan Schiff ( ⁴ d.schiff@elsevier.com )

McNeil Elevates Quality Management In Wake Of Tylenol, Motrin Recall

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