By Susan Heavey
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 officer 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.
"Since then, we have obtained additional documents, which raise troubling questions about both the accuracy of J&J's earlier testimony and the extent of the 'phantom recall,'" Committee Chairman Edolphus Towns said at the beginning of the hearing.
In probing the April recall of children's medicines, the committee discovered that J&J had hired outside contractors in 2009 to buy packages of adult Motrin that had dissolving problems.
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 -- a total of 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 40 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
Lawmakers want to determine if the FDA knew about the stealth Motrin 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 email 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 Towns is pushing through legislation.
"Even if the FDA was technically aware of it, that does not excuse what Johnson & Johnson did," Towns said. "Johnson & Johnson had both the legal and the moral obligation to do the right thing, and they did not."
Despite the recalls, shares of J&J, a huge diversified healthcare company, have largely tracked the broader market. They were up about 0.1 percent at $62.35 in morning trading, while the Standard & Poor's 500 index rose 0.5 percent.
Chief Financial Officer Dominic Caruso told investors in July that the recalls cut quarterly sales by $200 million, or about 5 cents per share.
(Additional reporting by Ransdell Pierson in New York; Writing by Andy Sullivan; Editing by Lisa Von Ahn)
