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.

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.