UPDATED: FDA warns small biotech Ocugen of potential $10K fines for failing to post trial results
The FDA is back to warning companies of $10,000 fines for failing to report the results of clinical trials, this time going after clinical stage biotech company Ocugen, known most recently for trying to bring a Covid-19 vaccine from India to the US and other markets.
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. Although as noted by the nonprofit Transparimed, which has dedicated resources to help this kind of reporting, it’s unclear why the FDA is taking so long to target companies after their trials finish, and to follow up after the company doesn’t respond to an initial letter. The agency previously sent more than 40 “Pre-Notices of Noncompliance” to encourage compliance with the ClinicalTrials.gov requirements.
But it’s been almost a year since the FDA warned the first company for this type of infraction, as it warned Acceleron for its failure to post results from a cancer trial, and similarly said the company has 30 days to correct this failure or it may have to pay a $10,000 penalty or face criminal prosecution. It’s unclear if any of the fines have actually been levied.
The agency also has targeted individuals running trials, including Los Angeles-based urogynecologist Andrey Petrikovets, who failed to release results from his trial, known as,”ICE-T Postoperative Multimodal Pain Regimen Compared to the Standard Regimen in Same Day Vaginal Pelvic Reconstructive Surgery: A Randomized Controlled Trial.”
Meanwhile, the pressure is on FDA to do more in this area. A group known as the Universities Allied for Essential Medicines is calling on FDA commissioner Rob Califf to help the agency do its job of enforcing these trial publishing requirements.
“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 FDAAA,” the UAEM wrote in a letter to Califf last week. “The FDA should therefore establish an actionable prioritization framework for enforcement of FDAAA, and demonstrate an intent to begin more rigorous enforcement.”
Ocugen told Endpoints News in an emailed statement:
Ocugen is committed to compliance and takes transparency regarding clinical data and trial reporting seriously. We submitted information to update the site after trial was completed. In November 2021, we updated the site with additional information, which is not reflected. We’ve been aware of the latest U.S. Food & Drug Administration’s request to update clinicaltrials.gov with results of our discontinued, OCU310 program. We’ve been in dialog with the agency ever since receipt of their letter and we will submit information as requested ahead of their deadline.
Editor’s note: Article updated with comment from Ocugen above.