Scripps Re­search In­sti­tute has set­tled a case with the Jus­tice De­part­ment al­leg­ing claims of mis­ap­pro­pri­at­ed funds, the US at­tor­ney for the dis­trict of Mary­land an­nounced late last week.

Pros­e­cu­tors said the in­sti­tute im­prop­er­ly used NIH-fund­ed re­search grants for non-grant re­lat­ed ac­tiv­i­ties, in­clud­ing work­ing on new grant ap­pli­ca­tions, teach­ing ac­tiv­i­ties and oth­er ad­min­is­tra­tive tasks. As part of the set­tle­ment, Scripps has agreed to pay $10 mil­lion.

Pros­e­cu­tors not­ed that no de­ter­mi­na­tion of li­a­bil­i­ty had been made in the case.

“The NIH has fi­nite re­sources to sup­port im­por­tant re­search across the na­tion,” said gov­ern­ment lawyer Jef­frey Clark in a state­ment on Sept. 11. “To­day’s set­tle­ment demon­strates our com­mit­ment to pro­tect those re­sources by en­sur­ing that NIH grants funds are used for the pur­pos­es for which they were in­tend­ed.”

Ac­cord­ing to the an­nounce­ment, Scripps re­ceives mil­lions of dol­lars in NIH grant fund­ing every year, and the set­tle­ment re­solves al­le­ga­tions that oc­curred be­tween 2008 and 2016. Scripps al­leged­ly did not pro­vide a prop­er ac­count­ing sys­tem for its re­searchers to keep track of time spent on non-grant projects. As such, the in­sti­tute charged the time to the gov­ern­ment rather than al­lo­cate it as in­di­rect costs.

The al­leged in­ci­dents were orig­i­nal­ly brought to light through a whistle­blow­er claim from a for­mer Scripps em­ploy­ee, who will re­ceive $1.75 mil­lion as part of the agree­ment. While at Scripps, their salary was al­leged­ly 100% charged to the gov­ern­ment for at least two years, ac­cord­ing to re­port­ing by the Palm Beach Post. 

A spokesper­son for Scripps told End­points News that the charges stemmed from an “ac­count­ing dis­crep­an­cy that av­er­aged less than half of one per­cent per year of the in­sti­tute’s an­nu­al fed­er­al grant fund­ing.”

The in­sti­tute’s state­ment con­tin­ued:

Through­out the course of the in­quiry the In­sti­tute ful­ly co­op­er­at­ed with the fed­er­al gov­ern­ment, pro­vid­ing all re­quest­ed doc­u­men­ta­tion and as­sist­ing gov­ern­ment in­ves­ti­ga­tors. No ques­tions were raised con­cern­ing the qual­i­ty or con­duct of our re­search or the con­tri­bu­tions of our fac­ul­ty to sci­ence, in­no­va­tion, and the im­prove­ment of hu­man health.

Scripps Re­search tremen­dous­ly val­ues the in­vest­ment the fed­er­al gov­ern­ment makes in sci­en­tif­ic re­search, and we are deeply com­mit­ted to us­ing this sup­port to its ut­most to make dis­cov­er­ies and in­no­va­tions that im­prove hu­man health.

Scripps is one of the most promi­nent sci­en­tif­ic in­sti­tu­tions in the bio­med­ical are­na, with lo­ca­tions in La Jol­la, CA and Jupiter, FL. Dur­ing the Covid-19 pan­dem­ic, Scripps ex­ec­u­tive vice pres­i­dent Er­ic Topol has been one of the staunchest pro­po­nents of in­dus­try trans­paren­cy, pub­licly push­ing for vac­cine mak­ers to di­vulge in­for­ma­tion about their tri­als. Mod­er­na, Pfiz­er and As­traZeneca, the three com­pa­nies con­duct­ing Phase III stud­ies in the US, each re­leased their safe­ty blue­prints with­in the last four days.

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

GlaxoSmithKline’s Benlysta isn’t alone in the small circle of approved lupus nephritis drugs anymore.

Little Aurinia Pharmaceuticals has gotten the green light from the FDA to start marketing its first and only program, voclosporin, under the brand name Lupkynis — something CEO Peter Greenleaf says it’s been ready to do since December.

Regulators went right down to the wire on the decision, keeping the company and the entire salesforce it’s already assembled on its toes.

GlaxoSmithKline’s HIV unit ViiV was dealt a stinging loss back in late 2019 when the FDA slammed the brakes on its application for a once-monthly injection based on manufacturing issues. Now, with that roadblock in the rearview, ViiV has finally made good on its promise to change the HIV game.

The FDA on Thursday approved ViiV’s Cabenuva (cabotegravir and rilpivirine) as a long acting, once-monthly therapy for HIV-positive adults who are virologically suppressed and on a stable antiviral regimen.