What Would Kamala Harris’s FDA Look Like?

by Raymond J. March

After an alarmingly bad debate performance and widespread pressure to drop out, President Biden formally announced he would not pursue a second term. Shortly after his announcement, the President endorsed Vice President Kamala Harris, and many joined him.?

Less than a week later, many news outlets announced that Vice President Harris had enough support to be the Democratic Party nominee. The New York Times writes that she “took command of the Democratic Party in 48 hours” as part of a “well-orchestrated cascade.”?

Leaving aside numerous concerns about how quickly all this happened, many confused voters are scrambling to recount Vice President Harris’s experience, accomplishments, and record of public service.?

It is a relatively short and murky list, leaving many playing a guessing game about what President Harris might do. Many news outlets speculate on how she might change healthcare , immigration , entitlement programs , and environmental policy .

I’ve yet to see anyone consider how the Food and Drug Administration’s role and activity might change under a Kamala Harris Presidency.?

It is not a trivial question. Since 2016, FDA Commissioners (who are appointed by the President) typically only serve for about two years . The agency regulates at least 20 percent of all US consumer products. The FDA, in particular, has a longstanding reputation for being politically malleable .

Vice President Harris’s connection to healthcare reform and health policy is limited. What is clear from examining her prior statements is that she is significantly more left on healthcare reform than President Biden. She’s previously supported the Medicare for All bill, vows to expand abortion access and continue restoring much of the Affordable Care Act. She’s also expressed a need to lower healthcare costs (like every President over the past 25 years ).?

However, the best predictor of future action is past behavior, and we can learn much about what the FDA would look like by looking at its role in US healthcare during the Biden Administration. As a sampling:?

• Physicians’ and the FDA’s disagreements regarding the agency’s “unlawful” liberalization of access to the abortion drug Mifeprex reached the US Supreme Court. The details of the case are numerous and complicated . However, setting a precedent for the Supreme Court to overturn/ support the FDA’s decisions on drug access is clearly a political conflict of interest.?
• Last year, the FDA proposed requiring laboratory-developed tests to undergo an approval process like medical devices, significantly increasing federal oversight. These tests are used in 70 percent of diagnostic decision-making. Laboratories are already bracing for this proposal to become law.
• The FDA has struggled to perform its primary mission to ensure public health. Citing a laundry list of costly mistakes and other incompetencies, the House Committee on Oversight and Accountability recently wrote on its website , “Under the Biden Administration, the FDA has stumbled from crisis to crisis.”?
• The FDA has at least 350 current food and beverage recalls. As I have written before in The Beacon, this list includes products without reasons for being recalled. Others have been in recall for years. Even when the source of food contamination is clearly known, the FDA still struggles to find solutions.
• Under the Biden Administration, the FDA played a major role in creating and prolonging two infant formula shortages. After the crippling formula shortage of 2022, the FDA underwent reforms to prevent similar events from happening again. It didn’t work .

Under a Kamala Harris Presidency, increased government involvement in healthcare could lead to these and other concerning actions.

Major polls have Vice President Harris’s mate trailing Trump and Vance. But things can change quickly during an election year (clearly). And healthcare reform remains one of the key issues voters care about.

President Kamala Harris is possible. So is her potential to reform the FDA to meet her vision for US healthcare. That should concern all of us.?

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