Oversight Democrats Emphasize Importance of Accessibility to Safe Food and Drugs, Debunk Baseless GOP Attacks on FDA

Washington, D.C. (April 12, 2024)—Rep. Jamie Raskin, Ranking Member of the Committee on Oversight and Accountability, led Committee Democrats in highlighting the crucial role of the Food and Drug Administration (FDA) in ensuring Americans have access to a clean and safe food and drug supply.

“An FDA that bases its decisions on political science rather than actual science is not in the best interest of consumers.  Congress must ensure that FDA is empowered to rely on the facts, rather than bend to the will of people pushing an ideological agenda,” said Ranking Member Raskin in his opening statement.

The hearing included testimony from Dr. Robert Califf, Commissioner, Food and Drug Administration. 

Committee Democrats emphasized the role of FDA in protecting consumers by ensuring safety, security, and access to millions of products.

• Rep. Melanie Stansbury said:  “I’m grateful for the opportunity to highlight the importance of science and science-based decision making in this hearing, and all that you are doing to protect the American people to ensure that we have access to medicines that work, that we have food that doesn’t harm us, and to ensure that every American can get life-saving care.”  She went on to acknowledge that “The FDA is truly on the front lines of that battle every single day, and we’re really grateful for the work that you do.”
• Rep. Shontel Brown said:  “The Biden-Harris Administration and Democrats continue to fight to protect and preserve women’s reproductive rights.  The FDA’s recent landmark approval of over-the-counter birth control moves us one step closer to reproductive freedom, even amid brutal, backwards, and barbaric abortion bans like Arizona’s, and other attacks in reproductive health, including my own state of Ohio.”

Committee Democrats condemned the attacks on FDA’s regulatory authority and science-driven approach.  

• Rep. Ayanna Pressley discussed the science-driven approach of FDA’s approval of mifepristone, noting that “Mifepristone has been on the market for almost 24 years, and more than 100 studies have affirmed its safety since.”  She went on to state: “There are hundreds of reasons why someone might want or need to terminate a pregnancy with medication abortion.  Policymakers and judges should not be the ones making decisions for them.”
• Rep. Jasmine Crockett said:  “As a representative from the area that Roe v. Wade actually initiated, I am appalled because, for whatever reason, some people want us to go back to horse and buggy in this country. …  And so with that, thank you for the work that the FDA does.  I respect your research.  I recognize that the courts don’t do research.  I also recognize that this chamber seemingly doesn’t care about research.  But because of the work that you do, there are lives that are being saved.  And I need you to be funded to the fullest extent to make sure that we can continue to save American lives.”
• Commissioner Califf testified:  “I am on record, and so are all of us, that it would be bad for the entire system of drug development and availability of medications in the United States if judges began overruling the FDA as a matter of routine.” 

Committee Democrats underscored the importance of cooperation between the private sector and FDA to address shortages and ensure a clean food and drug supply.  

• In response to a question from Ranking Member Raskin, Commissioner Califf responded: “I think the best way to think about FDA in general is that we’re referees.  You all in Congress actually write the rule book, much like in any sport.  It’s the leadership that writes the rule book.  We enact what’s in the rule book, and in the case of food establishments, like most boards, the first line of defense are the players in the game, which is the industry that produces the products.  And by and large, they do a great job, but sometimes they don’t.  And as referees, we have to be really wise about where we step in because we don't have an unlimited budget.  So, what keeps us from inspecting all 275,000—you don't have to be a brilliant mathematician to know how many people you’d have to have.  But what we can do, for example, in food for children is to have the manufacturers be required to do the testing, which is the way the drug system works.  The manufacturers of drugs have to test every batch, and in the case of cinnamon in applesauce, if there had been mandatory testing when it got imported into the U.S. from Ecuador, the stores that were selling it probably would have picked it up at that point. 
• Rep. Summer Lee emphasized that:  “From COVID-19 vaccine manufacturing failures to dangerous lead levels in children’s applesauce products, we’ve seen the private sector repeatedly fall short.  In response, Commissioner Califf testified:  “The primary first line responsibility is with the regulated industry.  This is a situation in which we oversee the industry, but the industry has the primary responsibility to produce safe and effective products, whether it’s a device, a drug, or a food. …   This has come out with regard to almost every commodity now that it would be better for public health, I believe, if we had direct recall capabilities across the spectrum of products that we regulate.” 
• Commissioner Califf testified:  “In the United States, the safety of medical, food, and cosmetic products depends on the actions of both industry and FDA.  Industry bears the responsibility of creating a supply of medical, food, and cosmetic products that are safe and protect and promote public health.  FDA guides and oversees industry to help ensure that Americans can have confidence about the medical, food, and cosmetic products they are using and that they are duly warned about the risks of tobacco products.” 
• In response to a question from Rep. Kweisi Mfume, Commissioner Califf testified that:  “We work every day with the manufacturers.  They’re required to give us certain information.  But frankly, they resisted giving us some of the crucial information that we really need.  When there is an impending shortage, we’re finding that they’re very cooperative to work together to try to fix it.  But it’d be better if we had all the data we needed to put together predictive algorithms that would allow us to intervene preemptively much, much earlier and prevent the shortage.”

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