FDA Warning Clinical Trial Companies For Not Reporting Trial Results
April 25th, 2022 // 1:28 pm @ jmpickett
FDA has restarted the policy of warning companies of $10,000 fines if they don’t report clinical trial results. In this case, they are warning clinical trial biotech company Ocugen. Most of us know Ocugen for attempting to bring a new COVID-19 vaccine to the US from India.
The trial that is being questioned by FDA was finished in May 2019. It was a Phase 3 clinical trial of brimonidine tartrate nanoemulsion eye drop made to treat dry eye disease. The company noted in its November 2019 SEC filing that the trial was completed and it showed the drug is usually well tolerated. Also, there were no severe adverse events, but it didn’t meet the required endpoints for signs and symptoms.
FDA has given Ocugen until May 15 to release the results of their clinical trial. It isn’t clear at this time why FDA has taken this long to go after firms after their clinical trials finish. They also are taking longer than expected to follow up if the firm doesn’t respond to a letter. In the past, FDA sent about 40 Pre-Notices Of Noncompliance that were designed to encourage FDA compliance with the requirements on Clinicaltrials.gov.
However, it’s been almost one year since the agency initially warned a company of this type of violation. It first warned Acceleron for not posting clinical trial results from one of its cancer clinical trials. It also said the firm had a month to correct the issue or it could have to pay a fine of $10,000 or face potential criminal prosecution. We don’t know if FDA has followed through on the fine.
FDA also is going after people running clinical trials, such as a urogynecologist named Andrey Petrikovets. He didn’t release his clinical trial results for ICE-T Postoperative Multimodal Pain Regimen Compared to the Standard Regimen in Same Day Vaginal Pelvic Reconstructive Surgery: A Randomized Controlled Trial.
FDA also is getting more pressure to take these kinds of actions against clinical trial companies. One non-profit called Universities Allied For Essential Medicines is asking the FDA commissioner to help FDA do its work to enforce clinical trial publishing standards.
Violations of this law have been many and often, and FDA could have levied at least $30 billion in fines. But FDA doesn’t usually this part of the law. However, it appears that FDA is beginning to put together a framework to enforce the law. Once they do that, it’s likely more clinical trial companies will release their results to avoid fines.
