Health

Sep 30, 2010 4:37 PM by AP

Johnson & Johnson and FDA Shouldered Blame For "Phantom Recall"

WASHINGTON (AP) - 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.

»Comments

»Topics in this article

Top Videos

1 2 3 4

Most Popular