In the first three years of the Trump administration, a grand total of 12 letters were sent by the FDA to drug makers warning them over violations found in their clinical drug trials. The agency’s warning letters are sent when the FDA notes violations of practice, procedure, or in some cases, law. In contrast, the first three years of the Obama presidency saw 99 such letters sent, while 36 letters resulted from the final three years of the two-term presidency. The discrepancy has experts wondering if the Food and Drug Administration’s authority is being undermined or compromised in some way under the current administration.
The journal Science filed multiple requests under the Freedom of Information Act to get the data used for the comparison. All in all, some 1,600 documents were found pertaining to trials that were violating federal rules regarding clinical drug trials. In some cases, the journal found evidence that laws themselves had also been broken. Agency inspectors conducted a significantly higher number of inspections of drug trials during the Trump presidency, but the consequences of such investigations were proven to be almost non-existent. In fact, less than 1% of inspections carried out under this administration have resulted in a warning letter being filed. Seven letters were used under the Obama administration to immediately halt an existing trial or stop new trials from being started under existing circumstances. No such action has ever been taken by the Trump administration.
The data is troubling because clinical trials involve testing drugs on real, live human beings. The consequences for the subjects can be dire, but at the same time, such a lack of oversight could also lead to the eventual release of a drug to the general public that is not safe for use. The erosion of the authority held by federal agencies to oversee drug trials only serves to enrich drug companies and has no positive outcome for the public that depends on them.
