Tylenol recalls referred to FDA crime division

joshua_sharfstein.gi.top.jpgFDA Commissioner Joshua Sharfstein testified about the recall of more than 40 infant and children's medicines produced by Johnson & Johnson. By Julianne Pepitone, staff reporter


NEW YORK (CNNMoney.com) -- An FDA official hammered the maker of Tylenol for a pattern of sloppy manufacturing practices that led to a series of recalls in testimony prepared for a House hearing on Thursday.

Dr. Joshua Sharfstein, the Food and Drug Administration's principal deputy commissioner, cited "significant violations" of manufacturing regulations by McNeil Consumer Healthcare.

The drugmaker McNeil, a division of Johnson & Johnson (JNJ, Fortune 500), has recalled products four times in seven months. That included a widespread recall of children's non-prescription drugs on April 30.

According to an FDA document, Johnson & Johnson also found out about a potential problem with Motrin tablets in November 2008, but did not issue a recall until July 2009.

Instead, said the document cited by the House Committee on Oversight and Government Reform, the company told contract employees to "buy up" large amounts of Motrin products from stores to test whether the medicine dissolved adequately. They were instructed "not to mention a recall."

"What we've heard today is not too reassuring or comforting," said committee chairman Rep. Edolphus Towns, D-N.Y. "I don't understand how something like this could happen at a company with such a long-standing reputation."

'Remote' health risks, but 'serious concerns': In Sharfstein's testimony, he stressed FDA experts found only "remote" risk to the public.

Despite concerns about bacterial contamination, none was detected in finished lots of Tylenol, Sharfstein said. "Tiny metal particles" in the products were also not a problem, he said, and no final products that were released for sale had high concentrations of the active ingredient acetaminophen.

However, Sharfstein also referenced an "extraordinary" meeting in February 2010, in which the FDA put Johnson & Johnson "on notice" because of the agency's growing concerns over whether the company's quality controls "ensure purity, potency and safety."

In January, Sharfstein said, the FDA had issued a warning letter to McNeil "expressing serious concerns about the company's control over the quality of its drugs and the company's failure to aggressively investigate and correct quality problems."

Upper management failed to assure timely investigation and resolution of those issues, Sharfstein said.

Potential criminal liability: During the hearing, Rep. Darrell Issa, R-Calif., asked another FDA official whether "a potential criminal liability" exists as a result of the recalls.

"Well, it has been referred to the FDA's crime division," said Deborah Autor, a director at the FDA's compliance office.

"I'm going to take that as a yes, that there are potential criminal charges and indictments," Issa responded.

According to a statement from Sharfstein, the FDA is "considering additional enforcement actions against the company for its pattern of non-compliance which may include seizure, injunction or criminal penalties."

Johnson & Johnson has suspended production at McNeil's Fort Washington, Penn., plant that manufactured the recalled children's products.

On Tuesday, Johnson & Johnson outlined steps to remedy the quality and safety lapses at its manufacturing facilities.

"You're making a lot of promises, and I hope you live up to it," Rep. Issa said. "I expect that after 100 years of consumer trust, you have a reason to." To top of page

Frontline troops push for solar energy
The U.S. Marines are testing renewable energy technologies like solar to reduce costs and casualties associated with fossil fuels. Play
25 Best Places to find rich singles
Looking for Mr. or Ms. Moneybags? Hunt down the perfect mate in these wealthy cities, which are brimming with unattached professionals. More
Fun festivals: Twins to mustard to pirates!
You'll see double in Twinsburg, Ohio, and Ketchup lovers should beware in Middleton, WI. Here's some of the best and strangest town festivals. Play
Index Last Change % Change
Dow 17,131.97 100.83 0.59%
Nasdaq 4,552.76 33.86 0.75%
S&P 500 1,998.98 14.85 0.75%
Treasuries 2.59 -0.00 -0.08%
Data as of 8:12pm ET
Company Price Change % Change
Apple Inc 100.86 -0.77 -0.76%
Bank of America Corp... 16.71 -0.03 -0.18%
Yahoo! Inc 42.71 0.16 0.38%
Alcoa Inc 16.16 -0.23 -1.40%
Facebook Inc 76.08 1.50 2.01%
Data as of 4:02pm ET

Sections

Anheuser-Busch, one of the NFL's biggest sponsors, says it is disappointed with how the league has handled recent controversies. More

Scotland's independence vote is too close to call but those who want to keep Britain united won this year's campaign funding race by some distance. More

The FBI's new facial recognition system lets local police easily identify you. It will one day spot you from your iris, voice and the way you walk. More

Y Combinator president Sam Altman is teaching a startup class at Stanford with Silicon Valley heavy hitters as guest lecturers. Bonus: All the videos will be available for free online. More

Market indexes are shown in real time, except for the DJIA, which is delayed by two minutes. All times are ET. Disclaimer Morningstar: © 2014 Morningstar, Inc. All Rights Reserved. Disclaimer The Dow Jones IndexesSM are proprietary to and distributed by Dow Jones & Company, Inc. and have been licensed for use. All content of the Dow Jones IndexesSM © 2014 is proprietary to Dow Jones & Company, Inc. Chicago Mercantile Association. The market data is the property of Chicago Mercantile Exchange Inc. and its licensors. All rights reserved. FactSet Research Systems Inc. 2014. All rights reserved. Most stock quote data provided by BATS.