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FDA warning: Report your clinical trial result or pay a $10,000 fine

The U.S. Food and Drug Administration has warned biotech company Ocugen that it will face a fine of $10,000 per day unless it makes a clinical trial result public.

In a letter sent on 15 April, the FDA warned the company that:

“FDA has determined that your company failed to submit results information for the applicable clinical trial… and is providing your company with the opportunity to remedy its noncompliance by submitting the required clinical trial results information within 30 calendar days after you receive this Notice of Noncompliance.”

“FDA may initiate an administrative action seeking a civil money penalty against your company… In addition to civil money penalties, violations of section 301(jj) of the FD&C Act (21 U.S.C. 331(jj)) could result in other regulatory action, such as injunction and/or criminal prosecution, without further notice.”

The trial in question, which involved 241 patients with Dry Eye Disease, should by law have made its results public by February 2020.

Endpoints reports that:

The trial in question with FDA, completed in May 2019, was a Phase III study of brimonidine tartrate nanoemulsion eye drop to treat dry eye disease. The company said in an SEC filing in Nov. 2019 that the Phase III trial has completed “and although the study showed that OCU310 is well tolerated, as demonstrated by no adverse events regarding as ‘severe,’ it did not meet its co-primary endpoints for symptoms and signs." The FDA is now giving Ocugen until May 15 to post the results from the trial.

The FDA’s letter explains that the agency initially contacted the company about its overdue clinical trial result in July 2021, but that the company did not subsequentrly upload the trial's results.

FDA under fire for weak enforcement

The episode highlights multiple weaknesses in the FDA’s enforcement process:

In an open letter, campaign group Universities Allied for Essential Medicines recently called for the FDA to step up its enforcement efforts:

“Although violations of the law have been so frequent and so flagrant that they could have generated over $30 billion in fines to date, the FDA has historically neglected its duty to enforce [trial reporting law] FDAAA. The NIH, which shares enforcement authority with the FDA, has stated that they have no obligation to enforce the law unless the FDA takes action first.”

“After significant pressure from the public, including our group of student advocates, the FDA has taken limited enforcement action only in the past year, sending, to date, four Notices of Noncompliance to trial sponsors.”

The group urged the newly appointed FDA commissioner to “prioritize clinical trial results reporting and make significant progress on this front.”

FDA enforcement in global comparison

Experts have long warned that failures to make clinical trial results public harm patients and public health. A recent study showed that 2,272 trials involving children had never made their results public.

While several jurisdictions have laws on the books requiring the results of (some) clinical trials to be made public, regulators have so far neglected to effectively enforce those laws.

The UK is currently moving to legally require all clinical trial results to be made public, and is expected to actively monitor and enforce that law. A recent UK proposal calls on the World Health Organisation – which has long been strongly supportive of clinical trial transparency – to develop a global action plan to improve clinical trial quality and transparency worldwide.

UPDATE 26 April

In a statement shared with Endpoints, Ocugen announced that:

"We’ve been in dialog with the agency [FDA] ever since receipt of their letter and we will submit information as requested ahead of their deadline.”


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