For over 10 years, mandatory reporting of clinical trial results to ClinicalTrials.gov had been part of Federal law. However, the FDA has never taken any enforcing action against parties not abiding to this requirement. Unsurprisingly, a piece of law that is not enforced is often ignored.
Now plaintiffs Peter Lurie, a former associate FDA commissioner who worked on transparency issues, and Charles Seife, a New York University journalism professor who has written for Science and other outlets, represented by New York University’s Law & Policy Clinic, have won a lawsuit against the Department of Health & Human Services and the FDA.
A federal judge in New York’s Southern District ruled that for years, government research agencies have misinterpreted the law that requires them to collect and post clinical trial data, leaving behind a 10-year gap in data that now must be made publicly available.
“This decision brings us one step closer to what federal law requires — providing the American public with complete access to clinical trial results on drugs and medical devices approved by the FDA,” said Christopher Morten, a supervising attorney at New York University’s Law & Policy Clinic. The ruling, Morten said, “makes it harder for drug companies, device manufacturers, and other trial sponsors to keep unfavorable trial results secret.”
“The FDA is in charge of making sure that drugs on the market are safe and effective, but without access to data about those drugs, it’s nearly impossible to understand whether the agency is doing its job properly,” plaintiff Charles Seife said in a statement.
While some clinical trial sponsors that did not post data between 2007 and 2017 are now officially out of compliance with the federal regulation, it is not clear how quickly they’ll be required to post their results —and what the consequences might be if they don’t.
Now potentially hundreds of universities, drug companies, and medical device manufacturers are compelled to release previously unpublished data. The ruling affects trials conducted for as-yet-unapproved drugs and devices in that 10-year stretch — meaning hundreds or even upwards of 1,000 noncompliant trials will be forced to post data.
This is a win for transparancy. Although it’s a sad state of affairs that a lawsuit is necessary for the FDA to do its job.