HEALTH

Congressional committee investigates J&J’s Motrin ‘phantom’ recall

BY Michael Johnsen

WASHINGTON Rep. Ed Towns, D-N.Y., on Thursday announced that the Committee on Government Oversight and Government Reform, which he chairs, has begun querying contracting companies on whether they were hired by Johnson & Johnson in late 2008 to execute a “phantom” recall of a certain SKU of Motrin available primarily through the convenience channel.

“Rather than doing the right thing and announcing a recall, we have learned that the drug company hired contractors to basically sneak into stores to purchase the products as if they were legitimate customers,” stated Towns.  “We need to better understand Johnson & Johnson’s relationship with the contractor and get to the bottom of the services the contractor was asked to provide.”

Towns had addressed the Motrin recall with Colleen Goggins, J&J worldwide chairman, consumer group, during last week’s hearing. Goggins testified that she did not know the specific language of the contract between J&J and the contractor, but that the Food and Drug Administration had knowledge of J&J’s particular actions in this situation at the time the contract was being executed.

The committee is examining an alleged attempt by J&J, parent company of McNeil Consumer Healthcare, to hire a contractor to go into retail stores and secretly purchase the suspect Motrin in order to avoid issuing a formal recall. Only when the FDA discovered this covert activity did J&J announce a recall of the affected medication, Towns asserted. “It wasn’t until this caper was foiled by the Food and Drug Administration that McNeil did what it should have done in the first place and recalled the affected medication,” Towns said. “The company’s motivation was apparently to save itself the embarrassment and potential financial loss associated with a recall.”

According to a document obtained by the Committee, WIS of San Diego was recruited by Carolina Supply Chain Services, now a division of Inmar, “on behalf of Johnson & Johnson” to purchase the affected Motrin.

Chairman Towns sent formal requests for information to WIS and Inmar today about their relationship with J&J, and asked for details on their alleged role in the phantom recall. The chairman also asked for the amount of Motrin that was purchased and what was done with those packages.

The committee learned of the phantom recall while investigating the recent recall of over-the-counter Johnson & Johnson/McNeil pediatric products, Towns said. This week, the chairman expanded that investigation to include the issue of Johnson & Johnson’s phantom recall of Motrin.

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AARP survey: Hispanics more sexually active than counterparts

BY Michael Johnsen

WASHINGTON According to a new AARP survey called “Sex, Romance, and Relationships Among Hispanics Age 45 or Older: AARP Survey of Midlife and Older Adults” that was released Wednesday, Hispanics over the age of 45 are more sexually active than their counterparts in the general population.

“Hispanics 45-plus continue to be more sexually active than the rest of the 45-plus population,” stated AARP’s Love & Relationships ambassador Pepper Schwartz. “For them, sex is a necessary component to living a happy and healthy life, and plays a critical role in relationships and overall quality of life.”

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Perrigo receives FDA approval for generic Monistat-1 Combination Pack

BY Michael Johnsen

ALLEGAN, Mich. Perrigo on Thursday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for over-the-counter miconazole nitrate vaginal cream and suppository, a generic to Monistat-1 Combination Pack, and expects to begin shipping immediately.

Annual sales of Monistat-1 totaled approximately $90 million and is indicated for the treatment of vaginal yeast infections and for the relief of external itching and irritation they cause, Perrigo reported.

Perrigo was the first to file an ANDA containing a Paragraph IV certification, and the resulting patent litigation filed by Johnson & Johnson previously was dismissed. Perrigo’s approval included 180 days of generic marketing exclusivity.

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