J&J, FDA face tough questions at hearings

Two Johnson & Johnson execs and an FDA official faced tough questions from Reps. Dennis Kucinich, Darrell Issa and Jason Chaffetz Thursday during the House Committee on Oversight and Government Reform's hearing regarding the company's recalls of children's medicines.

After the House members offered their statements, CEO Bill Weldon was quick to own responsibility for the recalls: "I know that we let the public down. We did not maintain our high quality standards, and as a result, children do not have access to our important medicines," he said in prepared testimony. "I accept full accountability for the problems at McNeil, and I will take full accountability for fixing them."

He also promised that a million bottles of a liquid Tylenol would be distributed next week--and 4 million by year's end. It was revealed that it will be grape-flavored Liquid Children's Tylenol, made at a plant in Guelph, Canada, the Wall Street Journal reports.

But a testy Kucinich wasn't going to make it easy on the company. He started by proposing that if it can be established a company knowingly avoided telling the public about a serious health problem, its corporate charter should be cancelled--that is, it should be put out of business. He also barked at the soon-to-retire Colleen Goggins, head of the company's consumer business, saying she wasn't answering his question, then stated that he believed her testimony was lacking in credibility. Kucinich observed Weldon and Goggins' testimony seemed to be coached by spin meisters.

Deputy FDA Commissioner Joshua Sharfstein followed the J&J execs. He said the company's activities exemplify the need for the FDA to be given authority to mandate recalls--a sentiment Committee Chair Edolphus Towns had echoed earlier in the hearing. But then GOP members took the FDA to task.

During his questioning, Chaffetz maintained that Maridalia Torres, the FDA's San Juan district director who worked with the company during the Motrin retrieval, should have testified in front of the committee. It was then that Sharfstein said that she could not, per the Justice Department. In fact, DOJ said she shouldn't testify because of a related ongoing criminal investigation--a baffled Chaffetz responded that he believed she should be able to testify, as he didn't believe it would hamper the criminal investigation.

Issa also grilled Sharfstein, saying FDA reps aren't exercising all the authority at their disposal and questioning how expanded agency authority can help. He also said the agency is heaping all the blame on the company--a charge Sharfstein denied.

"The pattern emerging at FDA is one of carelessness, deficiency, and untruthfulness," Issa said, as The Hill notes. "Johnson & Johnson and its subsidiaries do not get a pass," he added, "[but] the government has failed to do its job." 

- get more from ABC News
-
read The Hill's coverage
- see the WSJ report
- check out the Philadelphia Inquirer's story

ALSO: During the meeting, Weldon, Goggins and Sharfstein were asked if they knew what "soft-market recall" meant. The phrase was used in the emails discussing the "phantom recall," but all three were perplexed, saying they had never heard the term. Goggins called the use of the word "unfortunate."

Related Articles:
J&J chief, FDA give warring testimony on recalls
J&J chief in hot seat at tomorrow's hearing
J&J: No written deal with FDA on 'phantom recall'

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