Fines left uncollected by the FDA for violations of a key pharma transparency law have today broken through the billion-dollar barrier.
The FDA Amendments Act was originally introduced to prevent companies from burying research results that show their drugs to be harmful or ineffective. Negative publicity around past disasters linked to hidden clinical trials seems to have pushed pharma companies into compliance. Today, the leading drug companies publish their trial results as required by law nearly all of the time, though some of the less prominent commercial trial sponsors continue to do badly.
In contrast, even some of the major universities and nonprofits perform dismally.
Among the top 20 trial sponsors, the worst performers are New York University School of Medicine (only 25% of trials reported), followed closely by Mayo Clinic (26%) and University of California, San Francisco (27%). These tail lights contrast sharply with other leading public institutions that have achieved 100% compliance, including Sloan Kettering, Johns Hopkins, Emory and University of North Carolina Chapel Hill.
If the FDA was enforcing the law, New York University School of Medicine alone would be facing a $7,647,109 fine for its illegal and unethical behaviour. However, to date, the FDA has not collected a single cent in fines.
Founder of TranspariMED Till Bruckner said:
"It is scandalous that the FDA idly stands by while some universities that conduct research on human beings routinely break a law designed to safeguard patient interests. Past experience shows that hidden trial results can have deadly consequences. New York University School of Medicine, Mayo Clinic and the University of California San Francisco are acting illegally and unethically. The FDA needs to protect patients and fully enforce the law, without delay."
The FDA has recently signalled that it may in future start selectively imposing fines on some occasions. Transparency advocates have sharply criticized the FDA's plan for lacking teeth.
The consultation process is ongoing.
The FDA Amendments Act requires some, but by far not all, clinical trial sponsors to post trial results onto the public registry Clinicaltrials.gov within 12 months of trial completion. The law theoretically came into force in 2007. The Final Rule for the law, setting out exactly how it will be applied, came into force in early 2018. The billion dollar figure includes only those trials that have broken the law since the Final Rule came into force.