12.14.21

At Hearing to Consider Dr. Califf, Senator Murray Emphasizes FDA’s Important Work to Tackle COVID-19, Opioid Crisis, Youth Tobacco Use, and More

*** WATCH SENATOR MURRAY’S FULL REMARKS HERE***

 

(WASHINGTON, D.C.) – Today, U.S. Senator Patty Murray (D-WA), Chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, led a hearing to consider the nomination of Dr. Robert Califf to serve as Commissioner of the Food and Drug Administration (FDA). At the hearing, Senator Murray emphasized the important work of the FDA to tackle the urgent challenges our nation is facing, and emphasized that the FDA needs an experienced leader, like Dr. Califf, who is ready to hit the ground running.

 

“Families also deserve to know they have an experienced leader at the FDA who understands the many challenges our nation is facing, and the importance of ensuring science comes first,” said Senator Murray in her opening remarks. “Dr. Califf has worked on these issues before—when he was previously confirmed to lead FDA in an overwhelming bipartisan vote and I look forward to working with him again to ensure FDA continues to protect families across the country, uphold the gold standard of safety and effectiveness, and put science and data first.”

During the hearing, Senator Murray focused on the critical role of the FDA to address the COVID-19 pandemic and meet our country’s need for testing, address the worsening opioid crisis, prevent youth tobacco use, and more. In her opening statement, Senator Murray also emphasized the important work ahead at the FDA to increase diversity in clinical trials—which have too often excluded pregnant people and people of color, ensure FDA keeps pace with discoveries and technological advances being made in medical science and biotechnology, and fight sky-rocketing drug costs by stopping drug companies from misusing the process to keep cheaper drugs off the market.

 

Senator Murray also noted the Committee’s work to give the FDA the tools it needs to do its work and keep families safe—including by reauthorizing expiring user fee agreements and making sure the Food and Drug Administration has the authority it needs to keep families safe from products that have gone for too long with too little scrutiny, including cosmetics and dietary supplements.

 

In her opening remarks, Senator Murray also made clear to Dr. Califf her expectation that the FDA always put science and data ahead of politics.

 

“Throughout this crisis, FDA has empowered its experts and ensured its decisions are based in science and data,” said Senator Murray. “And as we have seen amid the growth of misinformation around issues like vaccines and reproductive health care, maintaining that commitment to always putting science first will be more important than ever to maintaining the trust of the American people.”

 

Senator Murray’s full opening remarks are below, as prepared for delivery:

 

“Families across the country count on the Food and Drug Administration every day to follow the science and the data, and keep them safe. And COVID-19 has put that role in the spotlight like never before.

 

“This pandemic has been incredibly hard on our nation—it has killed over 800,000 Americans, and upended our lives in countless ways.

 

“As we continue our work to end this crisis and rebuild our nation stronger and fairer, we are all grateful for the tireless work of FDA scientists to review and authorize safe and effective tests, treatments, and, of course, vaccines for COVID-19.

 

“And while the COVID-19 pandemic remains one of the most urgent challenges our nation faces, there are countless other ways FDA’s work matters to families.

 

“Every day, people put the wellbeing of themselves, their families, even their pets—in FDA’s hands.

 

“When we sit down for a meal—we count on FDA’s efforts to ensure the safety of our food supply, and provide us with the information we need to make healthy choices.

 

“When we get our prescriptions filled, or rely on medical devices to stay healthy—we count on FDA’s work to uphold the Gold Standard of safety and effectiveness.

 

“The FDA needs strong leadership to continue that work, and to address other pressing challenges. Challenges like the opioid crisis. We lost over 100,000 people to drug overdoses between April 2020 and April 2021. That is an all-time high, and nearly double the number of deaths we saw only five years ago.

“Challenges like youth tobacco use. E-cigarettes and other flavored tobacco products have led to skyrocketing tobacco use among kids. According to the CDC two million youth use e-cigarettes, and a quarter of that group uses them daily.

 

“Challenges like anti-microbial resistance, a threat which could make current treatments for infections fundamentally ineffective, and common procedures—like joint replacements, organ transplants, and C-sections—life-threatening. 


“Challenges like improving health equity. We know too many communities are left behind in our public health response, including in clinical trials which historically have left out certain populations like people who are pregnant, people of color, and others.

 

“This undermines people’s health by delaying information they and their health care providers need to understand how a treatment will affect them specifically or whether it is safe during pregnancy, and by making it hard to identify differences in the safety and efficacy of treatments for these patient populations. So, over the last few years, I’ve repeatedly raised the need for FDA to improve diversity in clinical trials.

 

“Then, there’s the constant challenge of keeping pace with discovery. Senator Burr and I are both focused on making sure FDA stays ahead of the massive discoveries and technological advances being made in medical science and biotechnology.

 

“And while we need a strong leader at FDA to tackle all of these challenges—we also need to make sure we are giving the Agency the tools it needs to do this work and keep families safe. That’s why, in the year ahead, this Committee is continuing its long tradition of working in a bipartisan way to reauthorize all the user fee programs set to expire in 2022.

 

“The user fee programs are critical to supporting the agency’s work to review and approve products, and uphold the gold standard of safety and effectiveness, in a timely and efficient manner.

 

“Without these programs it would take longer for FDA to help bring safe and effective medical devices to the U.S. market, and to review generic and biosimilar drugs, which can lower drug costs by offering patients cheaper alternatives for drugs they need.

 

“And as we work to support FDA’s drug review process, we also need to stop drug companies from misusing the process to keep cheaper drugs off the market. Patients desperately need us to fight skyrocketing drug costs with every tool in our arsenal. This includes making sure affordable drugs aren’t kept off the shelf by pharmaceutical companies who are gaming the FDA approval system.

 

“We also need to make sure the Food and Drug Administration has the authority it needs to keep families safe from products that have gone for too long with too little scrutiny.

 

“When it comes to cosmetics, we have discovered known carcinogens like asbestos and formaldehyde in products like baby powder, children’s make-up kits, and hair products. And when it comes to dietary supplements, people across the country who are looking to make healthy choices, are faced with a shelf full of products that make claims about their health benefits but lack rigorous oversight, because FDA does not have the authority to collect basic information about these products — or even to know what products are on the market.

 

“Families across the country buy and use these items every day. They deserve to know all the products they entrust their health to are subject to type of careful FDA oversight they already trust to keep their food, drugs, and medical devices safe.

 

“Families also deserve to know they have an experienced leader at the FDA who understands the many challenges our nation is facing, and the importance of ensuring science comes first.

 

“Dr. Califf has worked on these issues before—when he was previously confirmed to lead FDA in an overwhelming bipartisan vote and I look forward to working with him again to ensure FDA continues to protect families across the country, uphold the gold standard of safety and effectiveness, and put science and data first.

 

“Throughout this crisis FDA has empowered its experts, and ensured its decisions are based in science and data. And as we have seen amid the growth of misinformation around issues like vaccines, and reproductive health care, maintaining that commitment to always putting science first will be more important than ever to maintaining the trust of the American people.

 

“And now, before I turn it over to Ranking Member Burr for his opening remarks, I seek unanimous consent to put in the record 13 letters in support of Dr. Califf’s nomination, signed by more than 90 organization representing health care providers, academic researchers, and patient advocates, including a letter from 6 former FDA Commissioners appointed by Presidents of both parties. So ordered.

 

“Now I’ll turn it over to Ranking Member Burr for his opening remarks and to introduce Dr. Califf.”

 

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