Though Congress adjourned Wednesday, the House Oversight and Government Reform Committee went ahead and heard yesterday from two Johnson & Johnson/McNeil executives and the FDA over the ‘phantom recall’ of defective adult Motrin earlier this year.
To refresh, J&J has been in the news quite a bit this year, primarily for its recall of more than 135 million bottles of children’s liquid medications in May after numerous consumer complaints and an FDA inspection of the plant in Fort Washington, Pennsylvania turned up raw materials that were contaminated with gram-negative bacteria.
At the hearing Thursday, J&J CEO Bill Weldon admitted that the company did not notify FDA that it was purchasing product in an April sweep of stores now known as the phantom recall. Emails obtained by the committee revealed that J&J contractors were instructed to buy up deficient bottles of Motrin while acting like regular customers so as not to alert employees or the public. Both Weldon and Consumer Group Chairwoman Colleen Goggins backpedaled on the “unfortunate language” and poor quality and notification systems, things that should have been done differently. There was a lot of Won’t Happen Again.
But these recalls were not just a case of unfortunate language and isolated mistakes, FDA Deputy Commissioner Joshua Sharfstein said: J&J had a big systemic quality problem. The FDA inspected every McNeil plant at least once in the last year, and every one was found to have “inspectional deficiencies,” which the agency has been working with McNeil to clean up.
Weldon, too, highlighted the cooperation with the agency on fixing the quality systems and said that the children’s medicines recalled earlier this year would be back on shelves next week.
But members of the committee were unmollified. Ohio Rep. Dennis Kucinich said that there was a pattern of concealment, and was incredulous when Goggins maintained she was unaware of a series of emails discussing the advantages of the “soft market withdrawal” of the Motrin over a regular recall.
And Missouri Rep. Lacy Clay grew impatient when he tried to get a straight answer on why the company didn’t even get to close to meeting an FDA rule that requires companies to notify the agency within three days of any suspected contamination, irregularity or other change in a drug:
Clay: You can twist my words if you want, but why didn’t you report it within three days?
Goggins: I don’t know which instance you’re talking about. If we did not sir, we should have.
Clay: Any of the incidents! You didn’t report it in a timely fashion, within three days.
Weldon: Sir if–
Clay: So why didn’t you? Simple question.
Weldon: Yes, that I cannot answer. I would say though in all instances, in some instances, I know that we did. I don’t know the specific instance. If we did not, it was a mistake on our part and we should have.
The FDA’s Sharfstein didn’t get a free pass, either. Though he said there was no evidence that FDA was aware of or had condoned the phantom recalls, Ranking Member Darrell Issa tore into the deputy commissioner for requesting recall authority, waving a binder of inspection reports from the Fort Washington plant at him and suggesting FDA should have shut the plant down instead of asking for more authority.
But Sharfstein made a clear and compelling case for why the agency should have mandatory recall authority: The agency currently cannot tell a company how to recall product, he said, or influence the timeline or execution of a recall, and if a company refuses to recall a product FDA believes to be unsafe, the agency can only take product off shelves through complicated and time-intensive court channels (you can read his full prepared testimony here).
“The event of the phantom recall raises important questions about the current voluntary recall system,” he said. “In this case, if FDA had had the authority simply to order a recall to be done in the right way, I do not believe these events would have occurred.”
Two bills before Congress now, the Drug Safety and Accountability Act and a House bill introduced by Committee Chairman Edolphus Towns, would give the FDA that authority. A third draft bill in Energy and Commerce would give FDA the same power.
Congresswoman Eleanor Norton from D.C. agreed with Sharfstein’s assessment that the current voluntary system depends totally “on companies providing accurate and complete information” to the FDA:
A voluntary system would assume all that to be the case. But I must say, it makes the same kind of assumption that was made for 10 years about the financial system, that voluntarily letting them go without regulations will do it.
In the same way, this voluntary recall notion is not only an oxymoron, I don’t see how we can continue to abide it, and expect companies to act any way but the way people do: to protect themselves, to protect their shareholders. And the only way to pierce that is with some form of regulation. If we haven’t learned that from financial reform, and now we’ve got to learn it through children’s medicines, we’ll never learn it.”
You can watch the full hearing at C-SPAN.
–Kate Petersen, PostScript blogger