RAY SUAREZ: Lawmakers continued their probe today of a drugmaking giant and the way it’s handled recalls and manufacturing problems. NewsHour health correspondent Betty Ann Bowser has the story. The Health Unit is a partnership with the Robert Wood Johnson Foundation.
BETTY ANN BOWSER: Johnson & Johnson has recalled over-the-counter medications for children and adults nine times in the last year for a range of problems. One of those recalls was the largest in history for children’s nonprescription drugs.
And, in recent weeks, the company has acknowledged that it and a subsidiary pulled adult Motrin from the shelves without publicly announcing a recall. Today, the company’s top executives were called before the House oversight committee to explain.
Committee chairman, New York Democrat Edolphus Towns:
REP. EDOLPHUS TOWNS (D-NY): We have obtained additional documents which raise troubling questions about both the acuity of J&J’s earlier testimony and the extent of the phantom recall.
When Johnson and Johnson learned it had a problem with one of its adult Motrin products in 2008 and 2009, the company hired contractors to go into stores and buy the product off the shelves, without saying it was a recall, so that the public and the news media would know what was really happening.
BETTY ANN BOWSER: Johnson & Johnson’s chief executive, William Weldon,
came to apologize, saying the company and its subsidiary, McNeil Healthcare, made a serious mistake.
WILLIAM WELDON, CEO, Johnson & Johnson: 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. I accept full accountability for the problems at McNeil, and I will take full accountability for fixing these problems.
I do think the McNeil personnel were trying to be transparent with the
FDA. McNeil also notified its customers that it would be sending in personnel to remove the products. Nonetheless, based on what I have learned since on the May hearings, including the points that this committee brought to light, it is clear to me that, in retrospect, McNeil should have handled things differently. And, going forward, if similar situations arise, they will be handled differently.
BETTY ANN BOWSER: Weldon also said he wasn’t personally aware of the
phantom recalls. Colleen Goggins is the outgoing head of McNeil’s consumer division that produced the recalled products. Ohio Democrat Dennis Kucinich sharply questioned her claims that she was unaware of the phantom recall.
REP. DENNIS KUCINICH (D-OH): Now, Ms. Goggins, since you’re head of this consumer group, are you trying to lead this committee to believe that you knew nothing about it, that, apparently, from this memo there was widespread discussion within your organization about a phantom recall, about the costs of the recall, about not being able to get cooperation from the marketing people? You’re at the top of this group, and you knew nothing about it? Really? Please, help us.
COLLEEN GOGGINS, worldwide chairman, Johnson & Johnson’s Consumer Group: I did not know at the time that I testified in May. I have since learned from looking at documents that there was a retrieval going on. I did not know that at the time.
BETTY ANN BOWSER: The FDA itself came in for serious criticism. Ranking Republican Darrell Issa from California:
REP. DARRELL ISSA (R-Calif.): Regrettably, the pattern emerging at FDA is one of carelessness, deficiencies and untruthfulness.
BETTY ANN BOWSER: FDA Deputy Commissioner Dr. Joshua Sharfstein acknowledged today they were aware of the repurchasing of Motrin as early as April 2009, but didn’t ask the company to recall the drug until July.
DR. JOSHUA SHARFSTEIN, principal deputy commissioner, Food and Drug
Administration: All it said was we’re going to retrieve it from the shelves or however they phrased it. It didn’t say that they would be telling people to act like regular customers or not disclosing the facts when they were asked about what happened when they went out.
I think that, in part, because there was limited information, that might have contributed to the delay. But I also think that FDA should have been asking questions right away.
BETTY ANN BOWSER: Dr. Sharfstein also pointed out that recalls have to be initiated by the manufacturers, not by the FDA.
DR. JOSHUA SHARFSTEIN: In this case, if FDA had the authority simply to order a recall to be done in the right way, I do not believe these events would have occurred.
BETTY ANN BOWSER: Some members argue that Congress needs to give the FDA authority to mandate recalls. But there is little prospect of that happening any time soon.