Johnson & Johnson, FDA take Heat over 'Phantom Recall'

Associated Press

Johnson & Johnson executives and the Food and Drug Administration both shouldered the blame Thursday for a secret recall in which hired contractors quietly bought up defective painkillers to clear them from store shelves.

J&J Chief Executive William Weldon told House lawmakers the company "made a mistake" in conducting the so-called "phantom recall," which is one of a string of problems that have drawn congressional scrutiny

In the same committee hearing, the FDA's deputy commissioner, Dr. Joshua Sharfstein, said his agency should have acted sooner to halt J&J's plan. At the same time, though, he stressed that regulators were not aware of the deceptive nature of the recall.

Sharfstein and Weldon testified before the House Committee on Oversight and Government Reform, which held its second hearing on J&J's unprecedented spate of recalls. The largest, involving more than 135 million bottles of infants' and children's Tylenol and other medicines, triggered the committee's investigation.

"We recognize that we need to do better, and we will work hard to restore the public's trust and faith in Johnson & Johnson," Weldon told lawmakers.

Democrats and Republicans pressed Weldon on its "phantom" recall involving 88,000 packets of Motrin, which Weldon acknowledged as "not one of our finer moments."

But lawmakers also pressed the FDA on when and what it knew about the activity. New Brunswick, N.J.-based J&J has repeatedly claimed it alerted the agency's officials in Puerto Rico, where the defective Motrin was originally manufactured.

Sharfstein said J&J informed the FDA of its plan to repurchase the pills - which did not dissolve correctly - in April 2009.

"From this point, it took until July for the FDA to tell the company that a recall should be conducted," Sharfstein said in his testimony. "In my opinion that message should have been given sooner."

But Sharfstein stressed that the FDA did not know J&J had instructed contractors to pose as regular customers while buying the product and to not alert store employees to their activity.

"Based on the documents I reviewed, I don't see any indication that the FDA was aware of the surreptitious, lying nature of the recall," he said.

Republican lawmakers criticized a "too cozy" relationship between FDA and J&J employees, citing months-long e-mail exchanges between the two before regulators took action. But Sharfstein said ultimate blame lies with J&J, pointing out that the FDA does not have the authority to order when and how companies conduct recalls.

"I think fundamentally the responsibility is with the company to handle their quality problems in a much different way," Sharfstein said.

Companies are advised to work with the FDA on recalls, although that isn't a legal requirement.

Committee Chairman Edolphus Towns, D-N.Y., has introduced a bill that would give the agency the power to order recalls.

The maker of trusted brands like Tylenol and Benadryl, J&J has announced nine recalls of drugs for children and adults since last September with problems ranging from too much active ingredient to tiny shards of metal.

In May, J&J closed its Fort Washington, Pa., facility, the largest manufacturing site for children's medications. J&J announced Thursday it would begin shipping its grape-flavored Children's Tylenol next week, the first of its children's formulas to return to the market.

Weldon said the company plans to invest $100 million across the company to improve facilities, equipment and operations around the world.

Weldon, who has been CEO since 2002, missed the committee's last hearing because of back surgery.

Testifying beside him Thursday was J&J executive Colleen Goggins, who oversaw the consumer division of the company's McNeil Healthcare unit during the recalls.

At the May hearing, Goggins told lawmakers she had no knowledge of instructions to contractors involved in the phantom recall to not tell store employees what they were doing. In her testimony Thursday, Goggins acknowledged that the company wrote those instructions.

"Based on what I have learned since May, I believe that McNeil should have handled things differently," Goggins said.

Goggins will retire in March, Johnson & Johnson announced this month.

J&J Expands January Recall to Add Benadryl, Tylenol

Bloomberg Business Week

 

Johnson & Johnson, under congressional investigation for a recall of children’s drugs, said it is expanding a separate January withdrawal of over-the- counter medicines to include lots that were “inadvertently omitted from the initial recall.”

The drugmaker’s McNeil Consumer Healthcare unit is recalling five product lots of Benadryl and Extra Strength Tylenol in addition to those announced on Jan. 15, New Brunswick, New Jersey-based J&J said today in a statement.

J&J is being investigated by the U.S. House Oversight and Government Reform Committee after pulling 40 types of children’s medicines on April 30. The January recall, of 500 lots of drugs including Rolaids, Motrin and some forms of Tylenol, was an expansion of a recall of Tylenol Arthritis Pain caplets announced in November 2009.

“This latest recall is further evidence that there are wide-ranging problems at Johnson & Johnson,” Representative Edolphus Towns, a New York Democrat and chairman of the oversight committee, said today in an e-mail. “I am troubled by what we have learned so far in our investigation and this latest development adds to my concern.”

Today’s recall involves four lots of Benadryl Allergy Ultratab Tablets, 100 count, sold in the U.S., and one lot of Extra Strength Tylenol Rapid Release Gels, 50 count, sold in the U.S., Trinidad and Tobago, Bermuda and Puerto Rico, J&J said in the statement.

J&J shares rose 72 cents, or 1.2 percent, to $59.14 at 4:15 p.m. in New York Stock Exchange composite trading. They have dropped 8.4 percent since Jan. 15.

Consumer Complaints

The January recall was the result of consumer complaints of a musty or moldy odor that has been linked to trace amounts of a chemical called 2,4,6-tribromoanisole, or TBA, found on storage pallets. The company received reports of nausea, vomiting and diarrhea after use.

The U.S. Food and Drug Administration sent a warning letter to J&J at the time, saying the drugmaker waited more than a year to notify regulators after getting complaints that tainted bottles of Tylenol sickened customers.

The medicine involved in that recall was made in J&J’s Las Piedras, Puerto Rico, manufacturing facility. The children’s medicines pulled this year were made in Fort Washington, Pennsylvania. The FDA is investigating all McNeil operations, and is closely monitoring J&J’s plan to correct its manufacturing lapses, Joshua Sharfstein, the agency’s principal deputy commissioner, said in May. The company may face seizures and criminal penalties, Sharfstein said.

Bonnie Jacobs, a spokeswoman for J&J, said the company had no further comment beyond its statement today.

F.D.A. Weighs More Penalties In Drug Recall

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.

Johnson and Johnson Recalls 43 OTC Children's Meds

The Washington Post

 

A division of Johnson & Johnson is recalling 43 over-the-counter medicines made for infants and children -- including liquid versions of Tylenol, Motrin, Zyrtec and Benadryl -- after federal regulators identified what they called deficiencies at the company's manufacturing facility.

The voluntary recall, which was announced late Friday by McNeil Consumer Healthcare, affects hundreds of thousands of bottles of medicine in homes and on store shelves throughout the United States and its territories and in nine other countries -- a vast portion of the children's medicine market.

The Food and Drug Administration is advising parents and caregivers to stop using the affected products, although Commissioner Margaret A. Hamburg called the potential for serious health problems resulting from the medications "remote."

FDA inspectors had begun a routine inspection April 19 in the company's Fort Washington, Pa., plant when they noticed "manufacturing deficiencies" that triggered the recall, said Douglas Stearn, a senior FDA official.

Stearn said the plant's manufacturing process was "not in control," a term regulators use to describe flawed procedures that affect the composition of medicine. Federal investigators do not know when the problems at McNeil began, but Stearn said that "this does go back in time" and that "we have to try to figure that out."

While the FDA investigates, McNeil has suspended operations at the facility. In a statement, the company said: "Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles." It said the problems may affect "purity, potency or quality."

Marc Boston, a McNeil spokesman, would not discuss the deficiencies cited by the FDA or say when the manufacturing facility was shut down. The company also declined to disclose the amount of products affected by the recall. In addition to the United States, Puerto Rico and Guam, the medicines were sold in Canada; the Dominican Republic; Dubai, in the United Arab Emirates; Fiji; Guatemala; Jamaica; Panama; Trinidad and Tobago; and Kuwait.

A complete list of recalled products is on the company's Web site.

McNeil received consumer complaints associated with some of the recalled medicines, but the company's decision to pull them was not made on "the basis of adverse medical events," said Boston, who declined to elaborate.

If a child who has taken any of the recalled medications exhibits any unexpected symptoms, parents or caregivers should contact a doctor, federal officials said. Consumers or health-care providers who experience problems connected to the recalled medicines are asked to contact the FDA.

As of Saturday, the FDA was not aware of any health problems related to the recalled products, said spokeswoman Elaine Gansz Bobo.

Parents and caregivers can use generic versions of the affected medicines; they are not affected by the recall. The FDA cautioned against giving adult versions to infants and children, noting the potential for serious problems.

This is at least the third major recall of Tylenol products by McNeil since 2008.

In January, McNeil recalled 49 types of Tylenol products made for adults and two Tylenol products made for children after consumers complained of a mold-like odor and of temporary and minor nausea, stomach pain, vomiting and diarrhea. The company determined that some of the medicines had been contaminated by trace amounts of a chemical that is sometimes present on shipping and storage material.

In 2008, McNeil recalled 21 types of children's and infants' Tylenol liquid products, saying that although the products met internal standards, an unused portion of one inactive ingredient did not meet all quality standards.