David Light, Valisure CEO

Val­isure in the hot seat: New Form 483 over a 2021 in­spec­tion as CEO fires back

The no­to­ri­ous drug test­ing com­pa­ny Val­isure, which has made a name for it­self by forc­ing FDA’s hand with some of its safe­ty-re­lat­ed un­cov­er­ings, re­ceived a let­ter this week af­ter the FDA un­cov­ered vi­o­la­tions at its Con­necti­cut-based test­ing lab in 2021.

The let­ter, which was sent on Dec. 5, stat­ed that the FDA is “con­cerned” that Val­isure was not aware of  drug sup­ply chain se­cu­ri­ty re­quire­ments.

Dur­ing an in­spec­tion last year, in­ves­ti­ga­tors had looked at records re­lat­ed to four “lots” of prod­uct that were in its pos­ses­sion, in­clud­ing records, test­ing re­sults and more. FDA in­ves­ti­ga­tors ob­served that the com­pa­ny had failed to in­ves­ti­gate sus­pect prod­uct and make “de­ter­mi­na­tions of il­le­git­i­mate prod­uct” in co­or­di­na­tion with the man­u­fac­tur­er.

In an email to End­points News, Val­isure CEO David Light em­pha­sized:

Quick sum­ma­ry is that FDA in­spec­tors came to Val­isure in May 2021 for a 6-week in­spec­tion over their ap­par­ent con­cern that we were per­form­ing GMP test­ing which we do not, and they pro­duced no ev­i­dence sug­gest­ing that we were and over DSC­SA which did not ap­ply to us even at the time of in­spec­tion be­cause we had sold our phar­ma­cy. The in­spec­tion re­sult­ed in a 483 that out­lined a se­ries of vi­o­la­tions that are ei­ther phar­ma­cy-re­lat­ed and there­fore un­re­lat­ed to our cur­rent op­er­a­tions or in­dica­tive of a fun­da­men­tal mis­un­der­stand­ing of Val­isure’s busi­ness which of­fers in­de­pen­dent cer­ti­fi­ca­tion and test­ing ser­vices that are pur­pose­ly not GMP.

Fur­ther in­spec­tion by the FDA ob­served that Val­isur­eRx did not have sys­tems in place to en­sure com­pli­ance with cer­tain “ver­i­fi­ca­tion re­quire­ments” and that Val­isure had nev­er filed an an­nu­al re­port with the FDA. How­ev­er, the US reg­u­la­tor notes that since the sale of its dis­tri­b­u­tion arm, Val­isure is not a li­censed dis­penser and that Val­isure was not en­gaged in whole­sale dis­tri­b­u­tion ac­tiv­i­ties at the time of in­spec­tion.

“We al­so are con­cerned that your dis­trib­u­tor and phar­ma­cy clients, de­spite not be­ing ob­lig­at­ed to per­form the same type of re­lease test­ing re­quired of fin­ished dosage form man­u­fac­tur­ers un­der CGMP, may re­ly on your test­ing while a drug is held for sale, to in­form their de­ci­sion to fur­ther place a drug in­to in­ter­state com­merce,” the let­ter said.

The FDA not­ed in the let­ter that it was con­cerned that “man­u­fac­tur­ers may re­ly on your ser­vices in the fu­ture to per­form con­tract test­ing to ful­fill CGMP re­quire­ments.”

The let­ter not­ed “method­olog­i­cal de­fi­cien­cies” that were found up­on the FDA’s in­spec­tion, in­clud­ing Val­isure not demon­strat­ing the an­a­lyt­i­cal meth­ods used to gen­er­ate cer­tifi­cates of analy­sis, not prop­er­ly ad­dress­ing out-of-spec­i­fi­ca­tion test re­sults, us­ing an­a­lyt­i­cal in­stru­ments that were not qual­i­fied for the test­ing be­ing per­formed and not hav­ing the cor­rect con­trol over an­a­lyt­i­cal da­ta.

While the FDA is con­cerned that Val­isure will use test re­sults for cGMP pur­pos­es, the com­pa­ny now has around 30 days to re­spond to the FDA to ad­dress the con­cerns.

Light said that cGMP test­ing is de­signed to be “prod­uct for­mu­la­tion-spe­cif­ic val­i­da­tion,” where­as Val­isure specif­i­cal­ly de­signs its test to be “broad screens” that can iden­ti­fy crit­i­cal is­sues.

“Cer­tain­ly, Val­isure’s high­ly im­pact­ful dis­cov­er­ies and stud­ies in the last few years strong­ly demon­strate how im­por­tant it is to em­ploy in­de­pen­dent test­ing/screen­ing in ad­di­tion to GMP test­ing/val­i­da­tion and that the two are not the same but com­ple­men­tary and much need­ed for pro­tect­ing pub­lic health,” Light told End­points.

Over­all Val­isure and Light em­pha­size that the com­pa­ny does not plan to con­duct or of­fer any form of cGMP test­ing and will plan to re­spond to the FDA with­in the time pe­ri­od.

Val­isure has been at the cen­ter of sev­er­al FDA-re­lat­ed sagas, in­clud­ing con­t­a­m­i­nat­ed heart burn and oth­er pills filled with ran­i­ti­dine, as well as sun­screens and sham­poos. Val­isure was al­so in the news this week as a fed­er­al judge dis­missed claims that the once top-sell­ing heart­burn med­ica­tion Zan­tac caus­es can­cer.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 157,500+ biopharma pros reading Endpoints daily — and it's free.

John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.