OIG re­port ac­cus­es FDA of not fol­low­ing poli­cies for for­eign drug in­spec­tions

A new re­port from the US De­part­ment of Health and Hu­man Ser­vices’ Of­fice of In­spec­tor Gen­er­al ac­cus­es the FDA of not fol­low­ing its poli­cies around for­eign drug in­spec­tions, and rec­om­mends some im­prove­ments.

The OIG re­port, re­leased on Thurs­day, found that the FDA has not al­ways fol­lowed its poli­cies and pro­ce­dures for for­eign for-cause drug in­spec­tions, and that the agency al­leged­ly mis­placed doc­u­ments to prove its lead in­ves­ti­ga­tors com­plet­ed their re­quired train­ing.

The OIG al­so ac­cused the agency of fail­ing to record cer­tain in­for­ma­tion such as whether an in­spec­tion was an­nounced, and lack­ing poli­cies re­quir­ing su­per­vi­sors to ver­i­fy that lead in­ves­ti­ga­tors com­plet­ed their train­ing.

The FDA blamed lim­it­ed re­sources and “un­ex­pect­ed events and com­plex cir­cum­stances,” ac­cord­ing to the re­port. Agency of­fi­cials told the OIG that due to mul­ti­ple lo­ca­tion moves, it had mis­placed records show­ing that lead in­ves­ti­ga­tors met the train­ing re­quire­ments.

The re­port notes that the FDA’s over­sight is be­com­ing more com­pli­cat­ed as drugs that used to be man­u­fac­tured in the US are go­ing over­seas. Ac­cord­ing to the OIG,  74 % of API man­u­fac­tur­ers and 54% of fin­ished goods man­u­fac­tur­ers are now lo­cat­ed out­side the US. Though the agency start­ed im­ple­ment­ing some changes to the for­eign in­spec­tion process in 2017, Con­gress has ex­pressed con­cerns.

“We rec­om­mend that FDA iden­ti­fy and im­ple­ment ad­di­tion­al ways to im­prove the time­li­ness of its for­eign for-cause drug in­spec­tion process. We al­so made oth­er pro­ce­dur­al rec­om­men­da­tions that are list­ed in the re­port,” the re­port states.

Ac­cord­ing to the OIG, the FDA agreed with the rec­om­men­da­tions and promised to work on im­prov­ing the time­li­ness of its over­all for­eign in­spec­tion process. The agency al­so said it would im­ple­ment a sys­tem to “bet­ter doc­u­ment and track in­ves­ti­ga­tors’ qual­i­fi­ca­tions and cer­ti­fi­ca­tion.”

“FDA al­so stat­ed that it is ad­dress­ing ways to re­duce the time spent writ­ing and re­view­ing EIRs and that it is con­duct­ing a work­load analy­sis for in­di­vid­u­als re­spon­si­ble for de­ter­min­ing fi­nal clas­si­fi­ca­tion, is­su­ing warn­ing let­ters, and hold­ing reg­u­la­to­ry meet­ings,” the re­port said. How­ev­er, no time­line was giv­en.

For­eign in­spec­tions have al­ways been a ma­jor top­ic for the FDA. For­eign drug fa­cil­i­ty in­spec­tions fell by about 10% from 2016 to 2018 as the FDA strug­gled to hire new in­spec­tors. At the time, Re­pub­li­cans ar­gued that the agency was not com­plet­ing enough for­eign drug in­spec­tions and that it couldn’t hire enough in­spec­tors.

In March, a bill came for­ward that would re­quire FDA to con­duct a pi­lot pro­gram to in­crease the num­ber of unan­nounced in­spec­tions of for­eign drug fa­cil­i­ties, which was a pro­vi­sion al­so in­clud­ed in the fed­er­al bud­get bill. The leg­is­la­tion would al­so is­sue a re­port to eval­u­ate any dif­fer­ences be­tween unan­nounced and an­nounced in­spec­tions, bar­ri­ers to con­duct­ing unan­nounced in­spec­tions, and chal­lenges to evening the play­ing field for do­mes­tic and for­eign drug in­spec­tions.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Up­dat­ed: Hit by an­oth­er PhI­II flop, Sanofi culls breast can­cer drug — sound­ing alarm for the class

Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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President Joe Biden signs the Democrats' landmark climate change and health care bill. From L-R: Sen. Joe Manchin (D-WV), Senate Majority Leader Chuck Schumer (D-NY), House Majority Whip James Clyburn (D-SC), Rep. Frank Pallone (D-NJ) and Rep. Kathy Castor (D-FL). (Susan Walsh/AP Images)

Pres­i­dent Biden signs ma­jor drug pric­ing re­forms in­to law: What's com­ing for bio­phar­ma?

President Joe Biden yesterday afternoon signed into law historic, decades-in-the-making new drug pricing reforms as part of a wider reconciliation bill that will likely take a chunk out of biopharma companies’ profits for some blockbusters just prior to generic or biosimilar competition.

The partisan bill (all Democrats in the House and Senate voted for it, and all Republicans voted against it) includes not only Medicare price negotiations — which won’t kick off until 2026, leaving ample time for a legal challenge — but mandatory inflation-related rebates, and a $2,000 annual cap on what seniors’ pay for their prescription drugs.

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Paul Perreault, CSL Behring CEO

CSL CEO Paul Per­reault de­ter­mined to grow plas­ma col­lec­tion af­ter full-year sales dip

As the ink dries on CSL’s $11.7 billion Vifor buyout, the company posted a dip in profits, due in part to a drop in plasma donations amid the pandemic.

However, CEO Paul Perreault assured investors and analysts on the full-year call that the team has left “no stone unturned” when assessing options to grow plasma volumes. The chief executive also spelled out positive results for the company’s monoclonal antibody garadacimab in hereditary angioedema (HAE), though he isn’t revealing the exact numbers just yet.