On Apr. 30, J&J's McNeil Consumer Healthcare unit announced a voluntary recall of 43 over-the-counter medicines, including versions of Tylenol, Motrin, Zyrtec and Benadryl for children, because of manufacturing deficiencies that affected the quality, purity and potency of the products. These medication are estimated to represent 70% of the market.
"The initial story was bad enough," Towns said. But the whole tale includes rolling recalls, management firings and manufacturing problems dating as far back as 2008.
Contradictions Between J&J and FDA Accounts
The committee has also revealed a "phantom recall" of Motrin from 2008 where, rather than issue a public recall to deal with a potential problem with the product, McNeil allegedly sent contractors out to stores to buy the product back. " J&J testified that there was no attempt to hide anything," Towns said, but according to the document, this is what McNeil told these contractors:
You should simply "act" like a regular customer while making these purchases. THERE MUST BE NO MENTION OF THIS BEING A RECALL OF THE PRODUCT!The closing statement recounts other differences between J&J and FDA accounts. J&J told the Committee staff that this most recent recall involved only 6 million bottles. But the FDA says it was more than 20 times that -- some 136 million bottles. J&J says none of its contaminated products has had any adverse health effects. But the FDA testified today that the issue of whether any of these products caused deaths is still being investigated.
"I was hoping that J&J would be completely forthcoming today, but I think there are still unanswered questions," Towns said, promising to pursue this further. Colleen Goggins, J&J's worldwide consumer group chairman, spoke at the hearings.
As for the FDA, the Committee found that the regulatory authority actually lacks some authority in recalls. "The FDA needs mandatory recall authority. They shouldn't have to persuade a company to recall suspect products," Towns said, adding he intends to introduce legislation to give FDA that authority.