PALLONE OPENING REMARKS AT PANDEMIC AND ALL-HAZARDS PREPAREDNESS ACT REAUTHORIZATION LEGISLATIVE HEARING

Hearing

"When COVID-19 hit, the federal government was not adequately prepared, and we have not done enough to prepare for the next threat.

Unfortunately, the legislation the Republican Majority has noticed for today continues to leave us vulnerable to future threats. It fails to make any significant new investments in our pandemic preparedness. It further politicizes public health by overriding the scientific decision-making of our public health agencies. And, Republicans have refused to include any legislation at this hearing to strengthen the resilience of the supply chain.

Throughout the public health emergency, health care providers, states, and emergency responders faced supply shortages of ventilators, PPE, critical medication, and testing supplies. And now we are seeing shortages of chemotherapy drugs that are threatening the path to recovery for so many patients battling cancer.

Weeks ago, Democrats introduced five bills that would help us strengthen the supply chain and none of those bills were included in today's hearing. Ranking Member Eshoo introduced a bill that would bring transparency to drug manufacturing. The United States is over reliant on foreign suppliers for critical drugs, and unfortunately, we don't even know how bad the problem is, or which drugs rely on foreign suppliers. Ranking Member Eshoo's legislation would help the Food and Drug Administration (FDA) understand the entirety of the drug supply chain, which would be beneficial if there is a manufacturing or quality issue that could lead to a shortage. FDA would then know what suppliers drug manufacturers are relying on so that it could quickly address the problem.

When drug shortages happen, FDA can work with sponsors to extend the shelf life of the drugs available in the market to the latest possible date without losing drug quality, effectiveness, or safety. However, obtaining scientific information from drug sponsors to support an expiration date change can sometimes take weeks or months--this is time patients may not have. The Ensuring Access to Lifesaving Drugs Act, introduced by Rep. Slotkin, would streamline this process.

Additionally, we know that there are times when FDA is not even aware that a shortage of a product is coming. When there are unforeseen demand spikes, FDA has little insight into these issues until the problem is already impacting patients. Bipartisan legislation from Representatives Jacobs and Mills would ensure manufacturers notify FDA when these demand spikes occur. Right now, there is also no requirement in place for medical device manufacturers to notify FDA of supply problems. Representative Castor has introduced a bill to fix that.

We also requested that the Republican majority finally take on the glaring drug safety risk that exists when a dangerous or contaminated drug must be recalled, but FDA has no power to pull it from the shelves. This Committee has worked to fix this problem before on a bipartisan basis, and it is time we finally get this done.

The Republican majority's refusal to include these bills at today's legislative hearing is irresponsible.

While the Majority was not willing to discuss drug and device policies, a few bills noticed for today's hearing would make strides toward improving our public health response. A bill introduced by Representative Underwood would strengthen real-time standardized data availability of emerging public health threats at the Centers for Disease Control and Prevention. As Dr. Walensky and others have testified, during the COVID-19 and mpox public health emergencies, CDC was often left with incomplete, inconsistent, and out-of-date data that hindered our response. This legislation would clarify their authorities, helping us prepare for emerging threats going forward.

We are also considering my bill to remove the requirement that the Senate confirm the CDC Director, a misguided change that the Senate insisted on including in our omnibus package at the end of last year. When President Biden took office, it was important that he was able to immediately appoint a CDC Director to lead the agency during the COVID pandemic. It is critical to have an expert CDC Director in place right away to respond to the public health threats with speed, focus, and foresight, and without furthering the politization of public health that has become too commonplace in Congress. And we all know that the Senate does not do anything quickly.

I also have serious concerns about policies that would allow congressional interference in the termination of a public health emergency, new and unworkable requirements for CDC guidance, and industry decision-making of the PHEMCE.

While it concerns me that the Republican Majority doesn't seem to appreciate the full scope of the challenges we face, I hope we can find a way to move forward in a comprehensive bipartisan way. It is important that we come together to learn the lessons COVID-19 taught us and reauthorize PAHPA on time."

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