Wyden Statement on Trump and FDA Polluting National Drug Stockpile, COVID-19's Outsized Impact on African Americans

As Prepared for Delivery

This afternoon the Finance Committee is holding its first meeting since March, focusing on the FDA’s failure to adequately inspect foreign drug manufacturers for safety. In my view, the head of the FDA ought to face tough questions in any hearing on this topic. But FDA Commissioner Hahn is not with the committee today because the Trump administration blocked his testimony. They did this to prevent the committee from holding the FDA’s point person accountable. I’d also asked for the committee to invite the journalist Katherine Eban here to testify because she literally wrote the book on this issue. That did not happen either. In lieu of that, I’ll ask consent to enter into the record testimony and articles from Ms. Eban on this subject.

While the committee meets for this hearing, COVID-19 is ripping through nursing homes and killing thousands of Americans every week. Unemployment is at near-Depression levels. The kindling laid down over of centuries of racial injustice was reignited by the murder of George Floyd. The president is agitating for more violence and more escalation. Our nation is suffering.

The injustice driving peaceful protestors to the streets over the last few days is woven throughout society. Since the committee is dealing with health care in today’s hearing, I’m going to start with an immediate piece of urgently needed health care reform. COVID-19 has hit the African American community harder than virtually any other group of Americans, and the status quo is immoral.

There is a long and terrible history of our health care system working against black people in this country, from simply not listening when they report symptoms right up to performing cruel experiments on black human beings. That’s part of why COVID-19 is having such an outsized impact on the African American community today. There’s a risk that when a COVID-19 vaccine becomes available, vaccination rates in the African American community may be lower than elsewhere – because many in that community, for understandable reasons, do not believe that American health care is really looking out for them.

So I want to make something clear: this committee has muscle when it comes to health care policy – $2 trillion in spending and jurisdiction over flagship programs like Medicare, Medicaid, the Affordable Care Act and more. Today I’m calling on this committee to come together in the weeks and months ahead and use all that power to right the wrongs of the past.

As for the subject of this afternoon’s hearing, I want to focus on one specific example of the FDA and the president teaming up to put Americans in danger. Let’s talk about hydroxychloroquine.

Back in March, with the pandemic exploding nationwide, far-right media began talking about using this old malaria drug to treat COVID-19. The president glommed onto those reports, and without any valid evidence, he spent weeks declaring it the ultimate game changer in the fight against the pandemic.

The FDA, in my view, bowed to the pressure and issued what’s called an “emergency use authorization” for the drug. Doing so threw open the door to tens of millions of pills, including some, directly related to this hearing, manufactured inside facilities in Pakistan and India that have either failed FDA’s inspection or never been inspected by the FDA at all. Studies have now shown that the drug has no benefit for COVID-19 patients. In fact, it is linked to higher rates of COVID-19 mortality.

Finally on April 24, the FDA warned against using the drug in COVID-19 treatments, citing “serious and potentially life-threatening heart rhythm problems,” but the FDA still says it can be imported from unapproved manufacturing facilities.

A recent article in the New England Journal of Medicine said the episode posed, quote, “fundamental threats to the U.S. drug evaluation process.” Mr. Chairman, without objection, I’d like to have that article inserted into the hearing record.

The fact is, lots of Americans take this medication to treat other diseases, including lupus and rheumatoid arthritis. It’s prescribed by their doctors, part of a valid treatment. They’re counting on having a safe supply of their medication, and Donald Trump took that away from them. He repeated a bunch of far-right pundits touting junk science, and now the U.S. market is polluted with tens of millions of hydroxychloroquine doses that may or may not be safe. It’s not clear there’s a system in place to distinguish them from other stockpiles that came from approved sources. So if you’re talking about FDA failures leading to greater risk for Americans, hydroxychloroquine is the case in point.

There’s also the botched rollout of COVID-19 antibody tests. There’s the emergency use authorization for faulty KN95 masks that pose a danger to health care workers and first responders. There’s the fact that the number of FDA inspections of foreign drug manufacturing facilities were already down under the Trump administration.

On this committee there’s bipartisan interest in seeing improvements at the FDA, and it makes sense to look for ways to build up our drug manufacturing capacity in the U.S. However, the Trump administration just handed a big contract for COVID-19 drug manufacturing to a company with no experience manufacturing drugs and no facilities in which to manufacture them.

That’s not a good enough plan to help COVID-19 patients who are suffering right now. It also raises serious questions about how this administration would handle a COVID-19 vaccine, if and when a vaccine becomes available.

There’s a lot to account for on this issue. It’s unfortunate that the Trump administration is continuing to stonewall our oversight by blocking Commissioner Hahn from answering our questions today. Still I thank our witnesses for joining us today, and I look forward to their testimony.

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