The US Food and Drug Administration (FDA), a federal agency in charge of issuing rules to ensure the safety in foods, drugs, cosmetics and medical devices, has come under pressure in recent months from President Donald Trump , who has sought a quick solution to the coronavirus pandemic while simultaneously undermining his administration's health and science experts.
The vaccines recently developed by BioNTech-Pfizer, Moderna and AstraZeneca have given Americans hope that a solution is close for a pandemic that has so far killed more than 280,000 people (9.12.2020) in the United States — the highest recorded nationwide death toll in the world.
The FDA will play an integral role in deciding whether the general public will have expedited access to the drug by the end of the year. On December 10, the agency's vaccine advisory committee will meet to review Pfizer's request for emergency use authorization and determine whether to begin the distribution process.
What is the FDA?
The FDA was formed 114 years ago when the US Congress passed its first major food and drug bill, the 1906 Pure Food and Drugs Act.
Today, the regulatory agency is part of the Department of Health and Human Services, and one of its primary tasks is to determine whether medical products and medicines are safe for use. According to the FDA's mission, it "is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable."
The FDA is led by a commissioner who is nominated by the president and confirmed by the Senate. There is no limit on how long a commissioner can hold the position, but a new president can choose to appoint a different commissioner.
Traditionally, the top FDA job has gone to medical experts. Current Commissioner Stephen Hahn, a radiation oncologist, was appointed by Trump last December to lead the agency.
The FDA vaccine advisory board
The FDA can often take years to approve a drug, but it has the authority to expedite the process for public health emergencies, such as the coronavirus pandemic. Right now, it is working to ensure that the recently developed coronavirus vaccines are responsibly rolled out to the public.
The agency's vaccine advisory committee, which will meet on December 10, consists of 15 voting members from the scientific and medical community who have been selected by the FDA commissioner. They will review the data available on the Pfizer vaccine and then decide whether to recommend it for distribution. However, it will then be up to the FDA to make the final decision to greenlight the vaccine distribution process.
The FDA's Trump problem
The agency has not escaped public scrutiny. For instance, during the past decade, it has been criticized for speeding up and over-approving opioid drugs, thus fueling abuse of painkillers and leading to addiction.
The last few months under the Trump administration have been especially rocky. During the summer, the president openly repudiated the FDA and its scientists through his personal Twitter account. As the election neared, Trump also made unsubstantiated claims that the agency had developed rules to purposely slow down the vaccine approval process, calling it a "political hit-job."
"President Trump has made the vaccine, and COVID itself, politically contentious," Lawrence Gostin, director of Georgetown University's health law institute, told DW.
The political interference along with mixed messages from the Trump administration and FDA leadership threatens to erode public trust in the agency. A poll conducted in September found that fewer than 1 in 10 people in the US had great trust in the FDA to look out for their interests.
Crisis of confidence
The FDA has also hurt its credibility by having to backtrack on its authorizations of COVID-19 treatments that had been touted by Trump but whose effectiveness remained unproven or questionable.
For instance, in March, the FDA initially approved the president's favorite medication, hydroxychloroquine, for emergency use. However, it reversed course three months later after it was proved that it was not effective in fighting the coronavirus.
Then, in August, Hahn had to publicly correct himself after making several misleading statements about the benefits of using blood plasma from COVID survivors to treat currently infected patients — a treatment which Trump had lauded and the FDA had approved in an expedited process.
Even though Hahn has recently attempted to reassure the public that the agency is listening to its scientists, Gostin believes he hasn't done enough. "There is considerable distrust in the COVID vaccine approval process in the US," Gostin said.
The level of trust could be crucial. While the pharmaceutical companies say the vaccines they have developed are effective, the FDA still has to convince people to take the shots once they're widely available.
Biden's vaccine distribution plan
When President-elect Joe Biden is sworn into office on January 20, he will take charge of a massive vaccine distribution process potentially started by the Trump administration.
"There will be a lot of new decisions to be made," said Natalie Dean, assistant professor of biostatistics at the University of Florida. "There are going to be questions [on] how to test the other vaccines."
Read more: Joe Biden's biggest task: Fighting COVID-19
Biden signaled his intent to focus on the pandemic and make his approach more transparent by naming a COVID-19 advisory board only days after winning the 2020 election. He has promised to let government scientists do their jobs without political interference, but he, too, will also play a role in assuring the public that the vaccines are safe.
Several more pharmaceutical companies are working to come up with different vaccines and treatments for COVD-19, guaranteeing the FDA will remain busy with reviews and approvals for months and perhaps even years to come.