The US Food and Drug Administration’s (FDA) oversight of clinical trials has become more lax under President Donald Trump, a new report finds.
Fewer warning letters have been sent to scientists conducting trials and fewer investigators have been disqualified compared to the first and final three years of former President Barack Obama’s tenure.
An investigation by the magazine Science, which reviewed thousands of FDA documents, found that fewer scientists have faced disciplinary action over the last three years than under Trump’s predecessor.
In fact, in most instances, the FDA concluded that no action was needed and that the trials could continue.
An investigation by Science found that during the first three years and final three years of Barack Obama’s presidency, the FDA sent out 99 and 36 warning letters, respectively, but just 12 have been sent out during Donald Trump’s first three years
A total of 24 scientists were disqualified from continuing research in the US under Obama’s eight years while only two have been disqualified during Trump’s tenure
For the investigation, Science reviewed nearly 1,600 inspection and enforcement of trials reported to be in violation of rules or the law.
The records cover the entirety of Obama’s two terms and the first three years of Trump’s term.
Science reports that the FDA has 102 inspectors who respond to whistleblower complaints, visit labs conducting clinical trials, and review records.
Over the 11-year-period, the agency conducted about 6,700 investigations.
Final results can declare no action is needed, voluntary changes are required or ‘official action indicated,’ known as an OAI.
Warning letters may also be sent out and, in the most serious of circumstances, scientists may be disqualified from continuing research.
During the first three years of Obama’s presidency, the FDA sent 99 warning letters to researchers over ‘serious transgressions’ committed during clinical trials.
Over the last three years of Obama’s tenure, the agency issued 36 such letters.
However, during the first three years of Trump’s term, the FDA issued just 12 warning letters.
More investigators were also disqualified during the Obama administration.
A total of 24 investigators were disqualified during Obama’s presidency, an average of three per year.
Meanwhile, two investigators have been disqualified during Trump’s tenure.
Six percent of FDA probes under Obama were classified as ‘official action indicated’ compared to less than one percent of all probes under Trump. Pictured: Lisa Taylor receives a COVID-19 vaccination from RN Jose Muniz as she takes part in a vaccine study in Hollywood, Florida, August 7
‘It certainly looks like FDA is enforcing clinical trial requirements much less frequently, which is troubling for protecting subjects’ welfare and ensuring the validity of data for our medical products,’ Patricia Zettler, an attorney who reviewed Science’s findings and worked at the FDA between 2009 and 2012, told the magazine.
In one instance, the Science investigation noted the case of Dr Michael Harris, an osteopath who was cited numerous times by the FDA for serious errors made in clinical trials.
Among the errors include not obtaining consent from trial participants, not disclosing medications the volunteers were taking and backdated records from his private firm, Aspen Clinical Research in Orem, Utah.
Dr James Baker (pictured) was one of two investigators disqualified during the Trump administration in 2018 after being investigated four times from 2009 to 2017
The FDA allegedly warned Harris that he could face fines or prosecution – and be disqualified from performing medical research in the US again.
However, he never faced any repercussions, trial volunteers were never told they may have been put at risk, and his firm still contracts with pharmaceutical and medical companies to this day testing various drugs.
Under Obama, the number of FDA inspections classified as OAI reached above 120 during his first three years and about 60 during the final three years.
That is about six percent of all agency probes, reports Science.
In contrast, fewer than 20 investigations have been classified as OAI during Trump’s first three years, making up less than one percent of all investigations.
What’s more, according to Science, the FDA halted trials or prevented review boards from approving new trials seven times during Obama’s first term.
Not one such instance as occurred during Trump’s tenure.
Sanctions have also been slower during the Trump administration. One of the two disqualified scientists was Dr James Baker, an allergist-immunologist based in Oregon.
According to Science, he was investigated four times between 2009 and 2017, and each investigation found at least one violation.
He broke numerous rules including injecting patients with experimental drugs while they were on other medication that could have interacted, had volunteers participating in more than one trial at a time, and even pretended he had seen patients on days he was not in the lab.
Each time, Baker apologized and promised the errors would never occur again. But, in 2018, he was finally disqualified.