Foreign Study Sites Escape FDA Oversight: Professor
FDA has less oversight of overseas clinical trials that are used to form the basis of approval for drugs in the U.S. than it does for domestically conducted trials, according to a recent study published in the Journal of Clinical Pharmacology. “My study highlighted loopholes in the agency’s oversight processes that exploited vulnerable people and led to faulty data for drug approval decisions,” says study author and University of Connecticut pharmacy professor C. Michael White.
In an online article discussing his research, White says that foreign trials that go wrong are often simply not disclosed and there are “virtually no on-site inspections.” For example, he said that an undisclosed trial in India showed that “patients were untruthfully told that their medication to treat mania was no longer available and that they could receive only an experimental drug or placebo. Some patients did not even know they were in a trial. In a study I published in 2020, I cited a trial performed in India in which electrocardiograms filed for multiple people were later discovered to be fraudulent copies from a single person. I also came across an example of large-scale data manipulation from Chinese study sites to make an experimental drug seem more effective than it really was.”
White says that in trials conducted overseas without FDA’s knowledge, companies can cherry-pick supportive trials and leave out those with negative findings. “Thus, the FDA may not have a complete picture of the drugs’ potential benefits and adverse events when deciding if it should be approved,” he says.
White contends that the number of drugs that are approved but later withdrawn or have new serious adverse event warnings has increased from 21 per 100 drugs before 2012 to 27 per 100 drugs thereafter. “This coincides with the dramatic shift to overseas clinical trials intended for FDA drug approval,” he says.
FDA attempts to reign in suspect foreign trials were allegedly dismissed by industry in drug user fee negotiations in 2017, according to White. He says FDA proposed a fee to fund trial site inspections in developing countries, but the companies refused. “As a result, foreign clinical trial sites are 27 times less likely to be inspected by the FDA than those in the U.S.”