J&J CEO faces U.S. lawmakers over string of recalls
WASHINGTON (Reuters) - Johnson & Johnson's massive recall of faulty medicines, including a quiet buyback of its Motrin painkiller, has angered U.S. lawmakers who will question the company's chief executive and a senior health regulator on Thursday.
J&J has recalled millions of bottles of potentially contaminated over-the-counter medicines such as Children's Tylenol and Benadryl, forcing one of its plants to shut down well into next year, and prompting a criminal probe and civil lawsuits.
The House of Representatives Oversight and Government Reform Committee called the hearing after a session in May that some members said just raised more questions.
"During the course of its investigation, the Committee has been concerned about the inconsistencies that it has uncovered," Democratic staffers on the panel said in a memo released ahead of the hearing.
J&J CEO William Weldon plans to say his company "let the public down," according to written testimony released on Wednesday.
He is announcing $100 million to improve facilities and operations and said at least one recalled product would be back on the market next week.
In April, J&J's McNeil consumer unit recalled 40 children's and infant products -- affecting 135 million bottles -- after Food and Drug Administration inspectors found filthy equipment and contaminated ingredients at a Pennsylvania factory.
Company and FDA officials say there have been no reported injuries from the recalled products.
Other witnesses at the hearing include FDA Deputy Commissioner Joshua Sharfstein and Colleen Goggins, the head of the McNeil unit, who is due to leave March 1.
Weldon has not announced any plans to retire but the recalls have tarnished J&J's reputation with consumers and marred his largely successful eight years at the helm.
MOTRIN RECALL
In probing the April recall of children's medicines, the committee discovered that J&J hired outside contractors in 2009 to buy packages of adult Motrin sold at convenience stores that had dissolving problems.
Lawmakers want to determine if the FDA knew about the stealth recall as J&J asserts. The FDA denies it approved the company's action.
FDA's Sharfstein plans to acknowledge that, overall, the recall was hampered by delays on all sides.
While FDA knew about some of McNeil's plans, the company "did not fully disclose the likely scale of the action or the way that the company was intending to proceed," according to Sharfstein's written testimony.
An e-mail released by the committee shows an employee for one contractor knew the buyback could be viewed negatively.
Pulling specific faulty lots "will take time and may draw suspicion to what we are doing," an employee for Inmar Inc told McNeil managers. "Some stores will not care, others will ask specifically what we are doing."
Darrell Issa, the committee's senior Republican, has questioned the FDA's handling of the situation and has asked the Department of Health and Human Services to investigate.
"There are growing concerns surrounding the relationship between the FDA and McNeil," he said.
FDA's Sharfstein said the incident highlights FDA's reliance on voluntary company actions and the need for greater agency power to demand recalls, something Committee Chairman Edolphus Towns is pushing through legislation.
Despite the recalls, shares of J&J, a huge diversified healthcare company, have largely tracked the broader market.
Chief Financial Officer Dominic Caruso told investors in July that the recalls cut quarterly sales by $200 million, or about 5 cents per share.
(Editing by Tim Dobbyn and Muralikumar Anantharaman)