FDA finds itself under congressional scrutiny alongside Johnson & Johnson even as the agency investigates and weighs possible enforcement against J&J following the firm's third OTC recall in eight months.

The House Oversight and Government Reform Committee will conduct a hearing May 27 as part of its investigation into the recall of 1,500 lots of liquid pediatric drugs manufactured by J&J subsidiary McNeil, including Tylenol , Motrin , Benadryl and Zyrtec brand products (¹ [A#05180190003]).

J&J CEO William Weldon was invited to testify and a committee spokeswoman said the executive "has expressed that he wants to cooperate with the chairman's invitation."

Chairman Edolphus Towns separately invited FDA Commissioner Margaret Hamburg in a May 18 letter to appear with Weldon before the committee. The spokeswoman did not say whether the New York Democrat invited additional witnesses.

Towns ascended to the Oversight and Government Reform chair in early 2009 with a reputation for being less combative toward the drug industry than his predecessor, Rep. Henry Waxman, D-Calif., who now heads the House Energy and Commerce Committee (² Also see "New House Oversight Panel Chairman Towns Less Combative With Industry" - Pink Sheet, 12 January, 2009.).

Towns' statements about the McNeil recalls show he may nudge industry to prioritize its responsibility to provide safe and effective products following such extensive quality system failures.

Although Energy and Commerce historically has been more likely to investigate pharmaceutical and dietary supplement companies, Oversight and Government Reform notes it has jurisdiction over "any matter." The spokeswoman said Energy and Commerce has the option of investigating McNeil separately.

In a May 6 release, Towns and ranking member Rep. Darrell Issa, R-Calif., point out the recall of liquid pediatric OTCs is McNeil's third since September 2009, when the firm recalled infant and children's Tylenol products because an inactive ingredient did not meet quality standards (³ 'The Tan Sheet' Sept. 28, 2009, In Brief).

From November 2009 through January 2010, McNeil recalled a total of 500 lots of Tylenol and other OTC drugs linked to contaminated shipping pallets used at a company facility in Puerto Rico. The firm received a number of associated adverse event reports from consumers and a resulting FDA warning letter in January.

"Taken together, these recalls point to a major problem in the production of McNeil products," Towns and Issa say.

Agency Also Questioned

In a May 6 information ⁴ request to Hamburg, the Oversight and Government Reform leaders note the McNeil recalls "raise questions as to the adequacy of FDA's response to repeated problems with McNeil's manufacturing practices."

Towns and Issa ask McNeil in a separate same-day ⁵ letter to provide records of ingredient supplier audits, internal investigations and AERs associated with any product dating to 2008. McNeil, like FDA, had until May 17 to respond.

Pressure from the committee and other lawmakers may compel FDA to make an example of the company and others in industry that the agency determines have persistent quality system shortcomings.

Towns and Issa pose seven questions to FDA regarding bacteria found in raw materials at McNeil's Fort Washington, Pa., manufacturing plant, the suppliers of the materials and what originally prompted the April 19-30 inspection of the facility. The recalled OTCs may contain improper levels of certain ingredients or potentially contaminated materials. No adverse events associated with the products have been reported.

Deborah Autor, director of the Office of Compliance in FDA's drug center, noted during a May 4 media briefing that the Fort Washington plant "was due to be inspected and we inspected it."

Autor also said FDA's full range of enforcement tools - including warning letters, product seizures, court orders and criminal penalties - will be considered in the McNeil case.

Longtime consumer protection advocate Sidney Wolfe said FDA should impose penalties that allow manufacturers no loopholes in compliance.

"Any company that has such an effect on the public health ... when it seems as though they've got serious manufacturing problems, [FDA] should just essentially say, 'If you want to sell any more, you're going to have to clean up all these things. And while you're cleaning up, you're not going to be producing anything,'" said Wolfe, head of Public Citizen's Health Research Group.

Short of such a hard-line response, the agency will struggle to bring companies in line with good manufacturing practices given its limited resources, said Wolfe, a member of FDA's Drug Safety and Risk Management Advisory Committee, in an interview.

Ongoing Investigation

The agency said on its Web site May 17 it is conducting a company-wide investigation of McNeil "to determine whether similar problems exist throughout the company and what additional steps the agency must take to ensure that these problems do not recur."

Though the company detailed to FDA a number of quality system and personnel reforms made in the wake of the January warning letter, the agency says it is unclear whether those changes were sufficient (⁶ Also see "McNeil Elevates Quality Management In Wake Of Tylenol, Motrin Recall" - Pink Sheet, 22 March, 2010.).

FDA's investigation comes on top of the internal review McNeil says it is undertaking with the help of independent outside experts.

Wolfe suggested McNeil management "was or should have been aware" of the shortcomings in its processes before FDA concluded its Fort Washington inspection.

He pointed out the recall was not announced until April 30, the last day of the inspection, according to the form ⁷ 483 FDA sent to the firm.

- Dan Schiff ( ⁸ d.schiff@elsevier.com )

FDA Feels Heat Alongside J&J As House Oversight Investigates OTC Recall

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