- The FDA is responsible for reviewing data on vaccines, drugs, and medical devices, and deciding whether these products should be approved for use in the United States.
- A new report in the medical journal BMJ claims that the FDA did not inspect enough clinical trial sites.
- The FDA has just 89 inspectors for its bioresearch monitoring program.
Experts say the Food and Drug Administration’s oversight of clinical trials for new vaccines and drugs is “grossly inadequate,” according to an investigative report released Wednesday by
The report documents what experts say is a failure of the FDA to not only inspect clinical trial sites, but also notify the public and scientific journals when it has identified violations at those sites.
While some of these problems occurred during the COVID-19 pandemic, when travel restrictions and other measures limited the FDA’s ability to do on-site inspections, experts say the agency’s problems are not new.
The FDA is responsible for reviewing data on vaccines, drugs, and medical devices, and deciding whether these products should be approved for use in the United States.
In addition, the agency conducts
According to the BMJ report, very few sites involved in testing COVID-19 vaccines or drugs were inspected by the FDA before those products were approved by the agency.
For example, nine of 153 Pfizer-BioNTech trial sites, 10 of 99 Moderna trial sites, and five of 73 remdesivir trial sites were inspected, writes investigative journalist Maryanne Demasi, author of the BMJ report.
During the early months of the pandemic, between March and July 2020, the FDA halted routine clinical trial inspections,
One expert interviewed by The BMJ said that instead of cutting back on inspections at this time — when COVID-19 vaccines and drugs were being developed at “warp speed” — the agency should have been ramping up its oversight.
The FDA told Healthline that it “takes its oversight of clinical trials very seriously, and continued in-person inspections in the United States and other countries during the pandemic.
“We prioritized inspections for COVID-related products, including vaccines, ensuring FDA-regulated COVID-19 products are able to be used to save American lives,” the agency spokesperson said.
In addition, the agency developed new oversight tools to continue its work during the pandemic, including remote site evaluation using live streaming and remote records requests, the spokesperson said.
However, one expert told The BMJ that it is not possible to do a thorough inspection remotely, because inspectors need to examine every aspect of the site — such as cleanliness, organization, and staff coordination.
Lack of clinical trial site inspections by the FDA is not new.
Between 2000 and 2005, the FDA audited fewer than 1% of the country’s clinical trial sites, according to a 2007 report by the Department of Health and Human Services’ Office of the Inspector General.
Currently, the FDA has only 89 inspectors for its bioresearch monitoring program, the agency told The BMJ, but has a goal of increasing this to an average of 100 per year.
These inspectors are responsible for monitoring thousands of sites in the United States and other countries, the report said.
Experts who spoke to The BMJ are also concerned about the lack of transparency around the results of inspections, including violations that are uncovered at clinical trial sites.
The FDA
Ana Santos Rutschman, SJD, a professor of law at Villanova University Charles Widger School of Law, agrees that making this information more available would be useful. “A little more transparency would not hurt the agency,” she said.
According to the BMJ report, the FDA also doesn’t inform scientific journals when sites participating in a clinical trial published in that journal receive a serious warning.
In response, the FDA told The BMJ that it doesn’t monitor all publications that stem from clinical trial data submitted to the agency.
Rutschman doesn’t think it is the role of the FDA, as a regulator, to notify scientific journals about problems with clinical trial sites.
Experts who spoke with The BMJ are divided on whether the FDA has the funding and other resources it needs to oversee all the research that is under its purview, both in the country and abroad.
One felt that more funding and staffing would alleviate some of these problems. Another thought that the agency has sufficient funding and staffing to get the job done.
According to one of the experts interviewed by The BMJ, the FDA has over 18,000 full-time employees.
But Rutschman said this doesn’t mean all of these people are available to do inspections.
“The FDA doesn’t just do drug regulation,” she said, “so the actual number of people they have available on the ground [to do inspections] is rather limited.”
Rutschman added that there are two questions involved with these discussions about the FDA
One is what will it take to change the situation, including funneling more resources to the FDA, she said, because “I think most people think the agency is underfunded.”
The second is, given the FDA’s current resources, is what it is doing acceptable?
“The situation right now is far from perfect,” she said, “but I think it’s on the reasonable side of things.”
“The part [of The BMJ report] that I agree with is that it probably should be easier to find out what has triggered some warning from the agency,” she said.“But I don’t see how you would expect the FDA to be everywhere at the same time. It’s just not possible.”