Chairman Cassidy Delivers Remarks During Confirmation Hearing on Nomination for FDA Commissioner

WASHINGTON - U.S. Senator Bill Cassidy, M.D. (R-LA), Chairman of the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee, delivered remarks during today's confirmation hearing for the nomination of Dr. Heidi Overton to be Commissioner of the U.S. Food and Drug Administration.

Click here to watch the full hearing.

Cassidy's opening remarks as prepared for delivery can be found below:

The Senate Committee on Health, Education, Labor, and Pensions will please come to order.

Thank you, Dr. Overton for appearing before the Committee and for your service to the nation. I appreciate our conversations over the past month.

The United States has led the world in lifesaving medical discoveries, accounting for 40 percent of the world's biotech-related patents for drugs. Because of FDA's review process, we produce twice as many novel chemical or biological products as European countries.

But we are losing our advantage.

Regulatory uncertainty and outdated frameworks at FDA stifle American innovation and push developers overseas - including to Communist China where there is a more streamlined regulatory environment. Yes, in some cases China is also cutting corners and ethical boundaries but that doesn't change our responsibility to make America a more attractive place for pharmaceutical companies to conduct clinical trials.

I recently released proposals to eliminate unnecessary barriers in FDA approval processes for different products, while ensuring the gold standard of review is maintained. This should be a top priority of any future Commissioner in close coordination with Congress.

Our next FDA commissioner must have the vision and drive to ensure continued American biomedical leadership. This would be a commissioner with a vision for reform, who knows how to get buy-in across the agency to embrace change, and whom the American people can trust to make product approval decisions based on unbiased, sound science.

Unfortunately, politicization and misinformation severely damaged the credibility of FDA and HHS.

Last week, HHS Deputy Secretary nominee Chris Klomp spoke passionately about the need to differentiate the scientific process from policy decisions. And to prevent political interference from blurring those lines. I mentioned in the previous markup about reports that the President considered giving OMB a direct role in individual NIH grant decisions. I repeat these decisions must be made by people that understand science, not politicians. I hope to see the White House decide against politicizing the approval process.

The next FDA commissioner must prevent politics and political prejudice from influencing regulatory decisions if there is no substantiating scientific evidence to support it.

In particular, the agency has failed to follow the science and act when it comes to dangerous chemical abortion drugs that kill innocent babies and harm mothers.

But some of these safety concerns are commonsense.

For example, the abortion drug is only approved for up to 10 weeks' gestation and should not be taken when the mother is at risk for an ectopic pregnancy. How do you check for an ectopic pregnancy without an in-patient ultrasound? You can't. How do you know the gestational age without an in-person scan. You can't. And how can we know the frequencies of these complications without the requirement that the doctor report an adverse event?

This is something the next FDA commissioner needs to take action on.

Beyond policy changes, FDA is in desperate need of stability. It needs strong leadership, someone who is radically honest with the American people and promotes science over ideology.

Dr. Overton, you're a medical doctor, you've seen patients. You have a deep understanding of the health care system and health policy. But I have concerns.

You were behind the President in the Oval Office when he signed an executive order to break up the vaccine schedule into more doses. This completely ignores the reality of families today who are struggling to make life affordable. They are not just inconvenienced but are losing money by taking time off from work and all the expense of taking a child to a physician. That's point number one.

The order is based on zero scientific evidence.

At the same event, the President called the MMR vaccine "quite lethal." Talk about zero scientific evidence. And this comes as unvaccinated Americans are being hospitalized and even dying of measles. To say that the vaccine is "quite lethal" is going to discourage people from being vaccinated when the scientific evidence says that getting vaccinated practically eliminates the risk of getting measles, of being hospitalized, transmitting the infection to other people and perhaps themselves dying, perhaps someone else dying. The risk is in being unvaccinated. That's what the scientific evidence shows.

When Dr. Saphier, the President's Surgeon General nominee, was asked before this Committee if the MMR vaccine is lethal, she said no, the vaccine is safe and effective. I will ask you that question today.

Dr. Overton, this Committee needs to know whether you will be radically honest. That you will use your authority to stand up for sound science and protect children's health. That you will unequivocally say that the MMR vaccine is safe and not lethal.

You will also need to ensure that uninformed ideologies do not influence FDA's decision on whether to approve individual products, even if the president is pressuring. This is something you will need to answer if you are to have the Committee's support.

With that, I recognize Senator Sanders.

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