McClain: The FDA Must Act to Improve Internal Controls and Prevent Crises from Happening Again

Press Release

"Six weeks ago, this subcommittee held its first oversight hearing on last year's infant formula crisis.

During that hearing, we heard from the former Deputy Commissioner in charge of the Office of Food Policy and Response, Frank Yiannas.

Mr. Yiannas' testimony highlighted many internal failures within the FDA that led to the crisis including the FDA's poor efforts to carry out one of its most critical missions--food safety.

His testimony also raised questions of why key facts about the crisis were omitted when Commissioner Califf, Dr. Mayne, and Mr. Yiannas testified before the Energy and Commerce Committee last February, and in the so-called independent Solomon Report.

Today's hearing will continue the long overdue oversight of the Food and Drug Administration's response to the infant formula crisis.

We will get answers to why the FDA has not been fully forthcoming with Congress and the public.

Today's hearing will examine why it took more than four months for inspectors to arrive at the Abbott plant in Sturgis, Michigan after babies started getting sick.

We will determine why it took so long for the Biden Administration to take action to secure the infant formula supply after a recall left shelves bare.

Why was the FDA unprepared for this crisis?

Why did they only inspect three of twenty-three infant formula manufacturing facilities in 2020?

Why did they fail to investigate whistleblower warnings?

Did the FDA follow its regulatory protocols?

Did the FDA respond quickly enough?

Was the FDA's so-called independent review truly independent? Was it a cover-up?

Today, I hope we will get answers to these questions to better understand exactly what happened.

American families must be confident that the FDA has ability to prevent a crisis like this from ever happening again.

In our previous hearing, we learned a lot about how this crisis happened and how it could have been handled better from former FDA officials.

Here is what we know so far:

The FDA ignored an Abbott employee's 34-page disclosure detailing concerns at the Sturgis plant.

The FDA's telework policies and lax approach to oversight left it unprepared to address supply shortages after the Sturgis facility was shut down.

The FDA has failed to prioritize food safety.

The FDA has not taken the action needed to prevent a similar crisis from happening again.

The American people paid the FDA 6.7 billion dollars this year.

In next year's budget, the FDA wants over 10 percent more -- totaling 7.2 billion dollars.

FDA leaders should have been doing their jobs.

FDA field inspectors should have been doing their jobs.

But they weren't -- and there were serious consequences.

And they still got their paychecks.

Now it's time for current FDA leadership to be held to accountable.

Here we will discuss what failures within the FDA led to the crisis.

We will discuss ways that the FDA can improve its internal controls to get ahead of potential disruptions and prevent future supply chain shortages.

We will discuss why the FDA has omitted key facts from the public.

We owe it to parents, caregivers, and infants, to get to the bottom of what happened and keep it from happening again.

As I said at our last hearing, the families of the babies that died from contaminated formula deserve answers on how this tragedy was allowed to occur in the first place.

Thank you to Dr. Mayne for being here. We look forward to your testimony.

Now I yield to Ranking Member Porter for her opening statement."

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