NY Times
Dr. Joshua M. Sharfstein, the F.D.A.’s principal deputy commissioner, left, and Michael Chappell, the agency’s acting associate commissioner for regulatory affairs at a Congressional hearing Thursday morning.
The agency is considering further actions against McNeil Consumer Healthcare, the Johnson & Johnson unit, after a pattern of violations in manufacturing and quality control practices led to a number of recent recalls, Dr. Joshua M. Sharfstein, the F.D.A.’s principal deputy commissioner, said at a Congressional hearing on Thursday.
On April 30, McNeil voluntarily recalled more than 136 million bottles of liquid pediatric Tylenol, Motrin, Benadryl and Zyrtec because they may have contained metal debris, too much of the active ingredient of the drug or inactive ingredients that failed testing requirements, the agency said. But McNeil’s problems go beyond those related to last month’s recall, including other forms of contamination, dating back two years.
During a session in which some committee members questioned McNeil’s integrity, Dr. Sharfstein noted lengthy delays by the company in reporting problems to the agency. And in one case, in 2008, he said, McNeil hired a contractor to quietly remove packages of Motrin from retailers for suspected quality problems — which he suggested was essentially an unannounced recall that was not reported to the F.D.A.
“This is something troubling to the agency,” Dr. Sharfstein said. “We think it reflected poorly on the company.”
He said the F.D.A. was “considering additional enforcement actions against the company for its pattern of noncompliance, which may include seizures, injunction or criminal penalties.”
Another agency official, Deborah M. Autor, the director of the F.D.A. Office of Compliance at the Center for Drug Evaluation and Research, told the committee that officials had referred the McNeil case to the office of criminal investigation, the agency’s law enforcement arm. That office works with the Justice Department to prosecute companies accused of violating the laws governing drug manufacturing and marketing.
The House Committee on Oversight and Government Reform called Thursday’s hearing to examine the circumstances surrounding last month’s recall and whether the F.D.A. had responded adequately. But the evidence presented indicated long-running problems.
“I have become deeply concerned about your company,” Representative Edolphus Towns, the New York Democrat who is chairman of the committee, told the Johnson & Johnson executive who testified. “It paints a picture of a company that is deceptive, dishonest and that has risked the health of many of our citizens.”
That executive, Colleen A. Goggins, the worldwide chairwoman of Johnson & Johnson’s consumer group, acknowledged lapses by the McNeil unit. “The quality and process issues that we found at McNeil, those which led to the recall and others, are unacceptable,” she said.
But she also defended the company’s integrity. “There was never any intent to deceive or hide anything,” Ms. Goggins said.
The products in the latest recall were made at a company plant in Fort Washington, Pa.
Ms. Goggins said that the risk of serious medical problems from the recalled products was remote and that there were no reports that the products had caused serious medical harm.
Earlier this week, an F.D.A. spokeswoman said that the agency had received reports of health problems associated with the recalled products, including several deaths. But she said the agency had not found evidence that the products had caused the reported health issues.
Ms. Goggins said McNeil had identified and rejected the children’s medicines that contained metal particles or higher-than-normal doses before they reached the marketplace.
As part of an overhaul of its manufacturing and quality control processes, McNeil has replaced several senior executives and is making systemwide improvements, Ms. Goggins said.
McNeil posted a statement on a company Web site this week saying that it was making improvements in every part of its manufacturing and quality control operations, including organizational changes, employee training and new procedures for investigating product problems.
But Mr. Towns, the committee chairman, said McNeil’s corporate conduct surrounding the recalls dating back several years raised integrity questions.
For example, Dr. Sharfstein said, in 2008, McNeil notified the F.D.A. that it had hired an outside contractor to buy samples of Motrin from retailers to determine whether problems with the drug’s ability to dissolve warranted a recall.
In 2009, however, the agency received information that the contractor had been buying up inventories of the product in what seemed to be an unannounced recall, he said. McNeil later initiated a formal recall of the products after the agency questioned the company about the contractor’s conduct, he said.
In answer to questions from Mr. Towns, who referred to the incident as a “phantom recall,” Ms. Goggins said that McNeil had notified F.D.A. officials that it had hired a third-party contractor to determine how much of the product in question was on the market. But she said that she could not account for the contractor’s actions and that she would provide the committee with further information.
Committee members also questioned the executive about other incidents cited by the F.D.A.
In 2008, for example, McNeil received several consumer complaints about a moldy smell emanating from some over-the-counter products that had been made at a company plant in Puerto Rico. Some people also reported stomach problems. But the company did not notify the agency of the issue until 2009, Dr. Sharfstein said.
“It should not have taken a year,” he said. “It should have taken three days.”
After hearing Dr. Sharfstein’s testimony, Representative Eleanor Holmes Norton, a Democrat from the District of Columbia, asked Ms. Goggins whether the delay amounted to a “cover-up.”
Ms. Goggins said that McNeil had initially tested the products for microbiological contamination and that the tests had come back negative. When the consumer complaints subsided, the company thought the problem had resolved itself, she said.
The consumer complaints picked up again in 2009. McNeil recalled products in November, December and in January after it determined that the odor was caused by contamination from a chemical used to treat wooden transport pallets that had leached into some products.
In an F.D.A. inspection report last month about the Fort Washington plant, the agency cited McNeil for similar issues — failing to properly investigate 46 consumer complaints of foreign particles and unidentified black bits in some products. McNeil received that report on April 30 and announced the recall that evening. In her written testimony, Ms. Goggins said that McNeil took each complaint and report seriously and sought to investigate each one.
“Reports of possible serious adverse events, for example,” she wrote, “are reported to the F.D.A. quickly.”
Some committee members said that if Congress wanted to prevent delayed actions by drug makers on defective medicines, it should give the F.D.A. the authority to recall such products and levy civil penalties on companies. The agency cannot now require a recall, but pharmaceutical companies may voluntarily recall problem drugs.
On April 30, McNeil voluntarily recalled more than 136 million bottles of liquid pediatric Tylenol, Motrin, Benadryl and Zyrtec because they may have contained metal debris, too much of the active ingredient of the drug or inactive ingredients that failed testing requirements, the agency said. But McNeil’s problems go beyond those related to last month’s recall, including other forms of contamination, dating back two years.
During a session in which some committee members questioned McNeil’s integrity, Dr. Sharfstein noted lengthy delays by the company in reporting problems to the agency. And in one case, in 2008, he said, McNeil hired a contractor to quietly remove packages of Motrin from retailers for suspected quality problems — which he suggested was essentially an unannounced recall that was not reported to the F.D.A.
“This is something troubling to the agency,” Dr. Sharfstein said. “We think it reflected poorly on the company.”
He said the F.D.A. was “considering additional enforcement actions against the company for its pattern of noncompliance, which may include seizures, injunction or criminal penalties.”
Another agency official, Deborah M. Autor, the director of the F.D.A. Office of Compliance at the Center for Drug Evaluation and Research, told the committee that officials had referred the McNeil case to the office of criminal investigation, the agency’s law enforcement arm. That office works with the Justice Department to prosecute companies accused of violating the laws governing drug manufacturing and marketing.
The House Committee on Oversight and Government Reform called Thursday’s hearing to examine the circumstances surrounding last month’s recall and whether the F.D.A. had responded adequately. But the evidence presented indicated long-running problems.
“I have become deeply concerned about your company,” Representative Edolphus Towns, the New York Democrat who is chairman of the committee, told the Johnson & Johnson executive who testified. “It paints a picture of a company that is deceptive, dishonest and that has risked the health of many of our citizens.”
That executive, Colleen A. Goggins, the worldwide chairwoman of Johnson & Johnson’s consumer group, acknowledged lapses by the McNeil unit. “The quality and process issues that we found at McNeil, those which led to the recall and others, are unacceptable,” she said.
But she also defended the company’s integrity. “There was never any intent to deceive or hide anything,” Ms. Goggins said.
The products in the latest recall were made at a company plant in Fort Washington, Pa.
Ms. Goggins said that the risk of serious medical problems from the recalled products was remote and that there were no reports that the products had caused serious medical harm.
Earlier this week, an F.D.A. spokeswoman said that the agency had received reports of health problems associated with the recalled products, including several deaths. But she said the agency had not found evidence that the products had caused the reported health issues.
Ms. Goggins said McNeil had identified and rejected the children’s medicines that contained metal particles or higher-than-normal doses before they reached the marketplace.
As part of an overhaul of its manufacturing and quality control processes, McNeil has replaced several senior executives and is making systemwide improvements, Ms. Goggins said.
McNeil posted a statement on a company Web site this week saying that it was making improvements in every part of its manufacturing and quality control operations, including organizational changes, employee training and new procedures for investigating product problems.
But Mr. Towns, the committee chairman, said McNeil’s corporate conduct surrounding the recalls dating back several years raised integrity questions.
For example, Dr. Sharfstein said, in 2008, McNeil notified the F.D.A. that it had hired an outside contractor to buy samples of Motrin from retailers to determine whether problems with the drug’s ability to dissolve warranted a recall.
In 2009, however, the agency received information that the contractor had been buying up inventories of the product in what seemed to be an unannounced recall, he said. McNeil later initiated a formal recall of the products after the agency questioned the company about the contractor’s conduct, he said.
In answer to questions from Mr. Towns, who referred to the incident as a “phantom recall,” Ms. Goggins said that McNeil had notified F.D.A. officials that it had hired a third-party contractor to determine how much of the product in question was on the market. But she said that she could not account for the contractor’s actions and that she would provide the committee with further information.
Committee members also questioned the executive about other incidents cited by the F.D.A.
In 2008, for example, McNeil received several consumer complaints about a moldy smell emanating from some over-the-counter products that had been made at a company plant in Puerto Rico. Some people also reported stomach problems. But the company did not notify the agency of the issue until 2009, Dr. Sharfstein said.
“It should not have taken a year,” he said. “It should have taken three days.”
After hearing Dr. Sharfstein’s testimony, Representative Eleanor Holmes Norton, a Democrat from the District of Columbia, asked Ms. Goggins whether the delay amounted to a “cover-up.”
Ms. Goggins said that McNeil had initially tested the products for microbiological contamination and that the tests had come back negative. When the consumer complaints subsided, the company thought the problem had resolved itself, she said.
The consumer complaints picked up again in 2009. McNeil recalled products in November, December and in January after it determined that the odor was caused by contamination from a chemical used to treat wooden transport pallets that had leached into some products.
In an F.D.A. inspection report last month about the Fort Washington plant, the agency cited McNeil for similar issues — failing to properly investigate 46 consumer complaints of foreign particles and unidentified black bits in some products. McNeil received that report on April 30 and announced the recall that evening. In her written testimony, Ms. Goggins said that McNeil took each complaint and report seriously and sought to investigate each one.
“Reports of possible serious adverse events, for example,” she wrote, “are reported to the F.D.A. quickly.”
Some committee members said that if Congress wanted to prevent delayed actions by drug makers on defective medicines, it should give the F.D.A. the authority to recall such products and levy civil penalties on companies. The agency cannot now require a recall, but pharmaceutical companies may voluntarily recall problem drugs.
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