Patients betrayed as FDA refuses to enforce clinical trial reporting law

American patients’ hopes for more transparency in medical research were dashed on Friday as the U.S. Food and Drug Administration flatly refused to effectively enforce a law requiring the results of many drug and medical device trials to be made public.

The FDA’s announcement came in its response to a Citizen Petition filed by Universities Allied for Essential Medicines (UAEM), an international student-led group that is advocating for greater clinical trial transparency across several North American and European countries.

Background

Following a string of high profile pharma scandals involving hidden medical evidence, Congress in 2007 passed the FDA Amendments Act with overwhelming bipartisan support. The law requires pharma companies, medical device manufacturers, universities and hospitals to publish the summary results of clinical trials on the public ClinicalTrials.gov registry within a year of completing a trial.

However, despite thousands of trials missing results on the registry, the FDA has still not imposed a single fine.

What did the Citizen Petition demand?

 

The Citizen Petition demanded that the FDA should:

1. Issue more warnings and finally start imposing fines

2. Focus its enforcement actions on the most important trials

3. Make public a list of the warnings it has issued

What was FDA’s response?

The FDA refused to commit to issuing more warnings, refused to impose fines, and claimed that it was already focusing on the most important trials anyway.

The only element of the petition that the FDA granted was to make public a list of the warnings it has issued. (This list is already online, and will be updated quarterly.)

TranspariMED's advocacy manager Marguerite O’Riordan said:

“The FDA’s response is deeply disappointing. Just as regulators across Europe are gearing up to enforce new clinical trial reporting laws, the U.S. federal agency in charge of protecting patients is publicly announcing that it will continue to allow powerful companies and institutions violate the law with impunity. American patients deserve better than this.”

FDA response in detail

Below extracts from FDA’s response, with comments by TranspariMED.

“FDA takes seriously its role in enforcing the ClinicalTrials.gov registration and results information submission requirements…”

TranspariMED: No, FDA, you clearly don’t.

“FDA notes that the summary results information available on the ClinicalTrials.gov data bank is only a portion of the extensive and comprehensive safety and efficacy data that may be submitted to and reviewed by FDA with a marketing application.”

TranspariMED: True, Clinical Study Reports (CSRs) include far more detailed data. Irony: While the European Medicines Agency and Health Canada make CSRs public, the FDA refuses to publish these documents.

“To the extent your Petition requests that FDA take enforcement action, FDA denies such request… legal action… can be resource intensive and time-consuming… Building an enforcement case requires identifying all of the evidence and determining which witnesses will testify… initial proceedings can be lengthy… a responsible party… may appeal…”

TranspariMED: True, but if FDA enforced the law a few times (rather than publicly announcing that it will continue to turn a blind eye), most companies and institutions would get the message and quickly fall into line. Also, FDA appears to have never requested additional funding from Congress for enforcing this law.

“FDA focuses [enforcement efforts] on applicable clinical trials of unapproved products in which the product is intended to address a significant public health need (e.g., COVID-19 and pivotal trials for recently FDA-approved products) and trials that include vulnerable populations (e.g., pediatrics, cognitively impaired participants).”

TranspariMED: Not true. Many FDA enforcement efforts to date have targeted trials that are of minimal clinical or public health significance.

The FDA’s full response can be found here. UAEM’s original Citizen Petition (which provides an exhaustive analysis of the law and enforcement gaps) is here. The UAEM website contains an overview of its ongoing work on clinical trial transparency. If you are a student and want to join the fight for clinical trial transparency, please consider joining UAEM.