Tuesday, January 10, 2012

J&J Sold Insulin Pumps After Learning of Defects, FDA Says - Businessweek

By Alex Nussbaum

(Updates the shares in the 10th paragraph.)

Jan. 10 (Bloomberg) -- Johnson & Johnson’s Animas unit kept selling insulin pumps last year after learning of malfunctions with the devices that prompted it to make design changes, the Food and Drug Administration said.

The agency faulted the J&J unit for not adequately explaining “why your firm continued to manufacture insulin pumps” after they “had known failures.” The issues with Animas’ One Touch Ping and 2020 pumps prompted a company investigation that started in April, according to the FDA’s letter, which was dated Dec. 27 and released today.

J&J, the world’s second-biggest seller of health-care products, has faced a series of safety recalls and FDA warnings over the last two years. The New Brunswick, New Jersey-based company pulled dozens of brands of over-the-counter medicines in 2010 as well as faulty artificial hips and also agreed to give the FDA expanded oversight over three manufacturing plants.

The pump malfunctions involved the device’s keypad, said Caroline Pavis, an Animas spokeswoman. The warning letter only “requested further clarification on our internal quality systems and processes,” she said. “The insulin pumps we manufacture meet all product specifications.

“We are dedicated to quickly resolving the FDA’s outstanding concerns,” she said in an e-mail. “We remain strongly committed to manufacturing and delivering products to our customers that meet high quality standards and the regulations of our industry.”

Penalties Possible

Last month’s warning could lead to fines or affect J&J’s chances of winning federal contracts, the agency said in the letter. The FDA gave the company 15 days to respond.

The pump failures last year led Animas to make a design change and to switch manufacturing to a different supplier, the FDA said. The device maker said that it conducted a hazard evaluation and held a risk evaluation meeting to assess the dangers to patients, according to the agency.

Still, Animas failed to explain “why it was acceptable for your firm to continue to use” remaining pumps “with known failure modes,” the agency said in the letter.

The FDA deleted some details of the pump failures in the letter it released, which didn’t explain the exact nature of the malfunctions. Pavis, the Animas spokeswoman, didn’t immediately respond to messages seeking more information.

J&J rose less than 1 percent to $65.20 at 4 p.m. in New York. The shares gained 4.9 percent in the 12 months before today. Pfizer Inc., based in New York, is the top seller of health products.

The December letter also faulted Animas for failing to quickly report three incidents to the FDA in which patients using Animas pumps were injured. Two of the incidents involved “user error” and in a third, there was no evidence the pump malfunctioned, the FDA said. Animas lacked proper procedures for identifying and reporting problems outside the U.S., the FDA also said.

--Editors: Bruce Rule, Adriel Bettelheim

To contact the reporter on this story: Alex Nussbaum in New York at anussbaum1@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

Posted via email from Jack's posterous

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