In her opening statement, Appropriations Committee Chair Rosa DeLauro (D-Conn.) accused agency officials of “dereliction of duty” by failing to immediately look into a whistleblower complaint about improper procedures at the Abbott facility in Sturgis, Mich.
“The FDA knew about what Abbott was doing in October,” DeLauro said of claims the company was falsifying records, failing to adequately clean the plan and releasing untested formula, “but it was not until late December that the FDA interviewed the whistleblower. And then, not until a month after that –late January — was the plant inspected in person. Abbott then issued a recall in February, some four months late.”
DeLauro also slammed the FDA for only releasing safety “guidance” for approved manufacturers, instead of requirements.
“You don’t have in place a mechanism that would guarantee the safety right now, you just don’t,” she told Califf. “That guidance does not allow you to determine and to define the safety of the products that may be coming from facilities that are not FDA-approved.”
Rep. Mark Pocan (D-Wis.) also swiped at the agency during his line of questioning, accusing it of failing to provided detailed information about the Abbott investigation.
“You can talk about it anonymously. You should talk about it [publicly],” Pocan said. “One problem I’ve seen over and over with the FDA in my 10 years here is you guys aren’t good at communicating. And, you know, this is something parents are asking us about, they want to know what happened. You all gotta get that down to explaining in a way that real people can understand. I understand there’s a science behind it. But it’s not acceptable to say that you can’t comment on it.”
During a second round of questioning, DeLauro revisited the transparency issue, telling Califf “you can’t hide behind an investigation.”
“We need answers. We need them now,” she continued. “Who received this report? What did they do with who was heading the FDA at that time? My understanding is that the acting commissioner was Janet Woodcock, what did she know about this? So who was handling all of this and was this report lent to the FDA and investigated?”
“Well, as I’ve said, you’ve got the timeline down and you’ve got the key issues. I know we have an oversight hearing next week [May 25]. And we’ll be prepared to go into much more detail at that point,” Califf responded. “And you know, as I’ve said, we could do better than we did.”
“Oversight committee next week,” DeLauro interrupted. “You’re before the committee that funds what you do. So this information is relevant to this subcommittee of appropriations.”
“I appreciate what you’re saying that — the investigation is not completed yet. And so I’m not in a position to answer specifics like that,” Califf hedged.
DeLauro then ripped Califf for his lack of response.
“You have no idea who received the document — physically received the document,” she said. “Where did it go? Or read it? What was the chain of command? You apparently don’t have any answers to that question. That is indicative of again, not responding to the seriousness of this issue. That says it all.”
During a media round earlier this week, the commissioner first posited that the issue is not a lack of baby formula, but problems with distribution.
“I don’t want this to sound in any way like we’re not concerned about the parents that are struggling to find formula for their children. That’s definitely happening in parts of the country,” he told CNN on Monday before insisting “there is formula out there.”
“But you know, the number of stock on shelves is about 90% before … the recall, and it dropped to about 79% at its lowest, and we’re on the way back up now.”
FDA is incompetent losers and the solution is to give them a shit ton of money.
amazin
https://nypost.com/2022/05/19/fdas-califf-to-face-lawmakers-during-baby-formula-shortage/
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