Ongoing Coverage of J&J’s Appearance Before House Oversight Committee
Johnson & Johnson CEO William Weldon will appear today before the House Oversight Committee to testify about the recalls and manufacturing problems that have recently plagued the drug maker.
As we wrote yesterday, Weldons prepared testimony reveals that one of the more than 40 types of childrens medicines recalled by the company earlier this year is about to make its return to store shelves, with one million bottles available for release next week. The testimony didnt specify which med it will be, so well be watching the hearing to see if that tidbit comes out.
In addition to this years recall, which included about 136 million bottles of over-the-counter liquid childrens and infants medicines, the hearing will also likely cover J&Js handling last year of a recall of Motrin pills and childrens Tylenol, the WSJ reports. That will include questions for the FDAs role in the run-up to that recall. The A.P. reports Joshua Sharfstein, the agencys deputy commissioner, will testify that the FDA knew about the problems with the recalled drugs earlier than it has previously said.
Colleen Goggins, the head of J&J’s consumer unit, will also testify. (J&J recently announced her planned retirement.)
We’ll update throughout the hearing with key developments:
10:28 a.m.: Weldon and Goggins are sworn in to start testimony.
10:30 a.m.: Weldon says, “We let the public down” and “I accept full accountability for the problems at McNeil, and I will take full accountability for fixing them.”
10:33 a.m.: Weldon discusses investing $100 million in the company’s McNeil unit, which made the recalled products, to improve quality standards.
10:35 a.m.: Weldon says J&J should have handled the 2009 Motrin recall differently, and will do so differently in the future.
10:38 a.m.: Weldon’s spoken testimony is much shorter than his written testimony submitted into the committee record, to comply with th five-minute rule.
10:39 a.m.: Goggins is at the microphone now. She acknowledges McNeil’s instructions to contractors not to engage in discussions with store personnel where contractors were buying up Motrin products during the “phantom recall.” Says McNeil should have been more straightforward with stores.
10:43 a.m.: Under questioning by Towns, Weldon says J&J “made a mistake” in not informing the FDA that it was buying defective Motrin off store shelves in 2009. “We firmly admit that,” he says.
10:45 a.m.: Goggins, in response to Towns’s questioning, says if J&J had to do it over again in the Motrin recall, “we would be more transparent, particularly with store personnel.” J&J was buying up Motrin products because it found they didn’t dissolve properly, which could delay relief of pain in users.
10:50 a.m.: Weldon says the McNeil plant in Fort Washington, Pa., where faulty products were made, will be “state of the art” when it’s refitted and reopened.
10:52 a.m.: Weldon says he doesn’t think cost cutting or financial issues were put ahead of quality at any of its facilities.
11 a.m.: Chaffetz grills Goggins, who says that people were fired as a result of the recalls. Doesn’t name names. Chaffetz blasts the “cozy” relationship between J&J and the FDA regarding the Motrin recall.
11:08 a.m.: Rep. Dennis Kucinich (D-Ohio) gets in on the action. Goggins says she didn’t know at the committee hearing in May about certain details of the Motrin recall. Kucinich says, “This testimony is lacking credibility.”
11:12 a.m.: Weldon is discussing an incident in which raw materials used in manufacturing were discovered to be contaminated with a certain bacteria. He says no product ever shipped had this contamination. But J&J accepted the FDA’s finding there was potential risk, and agreed to make a recall.
11:25 a.m.: Weldon says the planned resumption of shipping of McNeil products next week is much sooner than J&J’s internal expectations, and he credits working closely with the FDA. He didn’t specify when J&J initially expected to resume shipping.
11:32 a.m.: Questioning ends. Weldon and Goggins get up from witness table. FDA Principal Deputy Commissioner Joshua Sharfstein is sworn in.
11:35 a.m.: The FDA’s Sharfstein says the agency hasn’t found any direct link between recalled McNeil products and any serious adverse events in users, including death.
11:37 a.m.: Sharfstein says a common concern with J&J’s recalls was the company’s failure to investigate and correct product problems in a prompt and thorough manner.
11:41 a.m.: Sharfstein says J&J omitted “phantom” part of the “phantom recall” from its notification to the FDA in 2009 regarding buying Motrin off store shelves, which complicated things. Still, he acknowledges the FDA should have acted sooner to push J&J to conduct an official recall.
11:42 a.m.: Sharfstein is asked, “Did FDA approve the phantom recall?” He responds: No.
11:47 a.m.: Sharfstein said that if the FDA had mandatory recall authority, things would have gone differently.
11:49 a.m.: Sharfstein says the FDA district director in Puerto Rico, who was monitoring the Motrin recall, is still in her post. He says the FDA declined to make her available to testify because the Justice Department said she is a central witness in a related criminal investigation. The DOJ probe of J&J has been previously disclosed by the company.
11:56 a.m.: Sharfstein says the FDA didn’t know that J&J contractors were going to be untruthful while going about buying Motrin products off store shelves.
Noon: Sharfstein is asked if he’s admitting the FDA didn’t do all it should have done in the J&J matter. “That’s correct,” he replies. He adds that the FDA is stepping up its enforcement efforts.
12:06 p.m.: Earlier in the hearing, Issa compared the FDA’s handling of J&J to the federal Minerals Management Service’s interaction with industry leading up to the BP oil spill. So far, no one has compared J&J itself to BP, however.
12:12 p.m.: Testy exchanges between Issa and Sharfstein. Issa says the FDA knew J&J was buying Motrin off store shelves, even if the FDA didn’t know about the “phantom” nature of the recall. Issa says Sharfstein has implied this was all J&J’s fault. Sharfstein says he didn’t testify it was all J&J’s fault.
12:21 p.m.: Sharfstein says the FDA received reports of adverse events in users of McNeil medicines that appeared to be linked to known risks of the drugs, not due to quality problems. Examples are drugs that can make a child “jittery” or if someone took an overdose. “That’s not because of the quality problem and production; that just happens,” he said.
12:22 p.m.: Hearing adjourns. Weldon shakes hands with committee members.
Photo of the Capitol dome by alykat via Flickr
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