Strik­ing while the iron is hot, six House De­moc­rats sent a let­ter Thurs­day to the act­ing chair­woman of the FTC (10 days af­ter the FTC said it would crack down on phar­ma merg­ers), call­ing for an in­ves­ti­ga­tion in­to the po­ten­tial col­lu­sion of in­sulin mar­ket lead­ers Eli Lil­ly, Sanofi and No­vo Nordisk.

Katie Porter

Led by Rep. Katie Porter of Cal­i­for­nia, the let­ter notes that the three com­pa­nies raised the prices of their in­sulins in lock­step, and be­tween 2012 and 2016, the price of in­sulin al­most dou­bled. Sen. Bernie Sanders (I-VT) and the late Rep. Eli­jah Cum­mings of Mary­land sent a let­ter to the FTC rais­ing sim­i­lar charges of col­lu­sion among the same three com­pa­nies in 2016.

“It is a unique­ly Amer­i­can phe­nom­e­non that pa­tients with di­a­betes are reg­u­lar­ly forced to ra­tion in­sulin and risk death,” wrote Porter, along with De­mo­c­ra­t­ic Reps. Lloyd Doggett (TX), Cori Bush (MO), Prami­la Jaya­pal (WA), Pe­ter Welch (VT), and Ro Khan­na (CA).

Last March, the FDA of­fi­cial­ly tran­si­tioned in­sulin prod­ucts from all three com­pa­nies from drugs to bi­o­log­ics, mean­ing com­pe­ti­tion would have to come in the form of biosim­i­lars, or even in­ter­change­able biosim­i­lars, rather than gener­ics.

Scott Got­tlieb

“The tran­si­tion of in­sulin from the drug to the bi­o­log­ics path­way will open up these prod­ucts to biosim­i­lar com­pe­ti­tion,” for­mer FDA com­mis­sion­er Scott Got­tlieb said in April 2019. “We’re al­ready see­ing ro­bust ac­tiv­i­ty among spon­sors seek­ing to bring for­ward biosim­i­lar copies of in­sulin.”

But one year since that tran­si­tion oc­curred, and the fruits of that ac­tiv­i­ty have not trans­lat­ed in­to new in­sulin biosim­i­lars yet.

For now, the House De­moc­rats are call­ing on the Biden ad­min­is­tra­tion to do some­thing, say­ing any ac­tion would align with its “com­mit­ment to equal­i­ty” as Black Amer­i­cans are fac­ing an epi­dem­ic of am­pu­ta­tions “large­ly caused by ex­or­bi­tant in­sulin prices,” the De­moc­rats wrote.

“It is clear that the in­sulin mar­ket is bro­ken, and we be­lieve that an FTC in­ves­ti­ga­tion and in­ter­ven­tion is long over­due,” they added.

Just 3 com­pa­nies con­trol near­ly all of our in­sulin sup­ply: Eli Lil­ly, Sanofi, and No­vo Nordisk. Shock­er: it turns out they raise prices in tan­dem—at least 13x in 10 years—while pa­tients are ra­tioning or starv­ing them­selves to try to cut costs. I want an­swers. pic.twit­ter.com/AtkH3OonTs

— Rep. Katie Porter (@Rep­KatiePorter) March 26, 2021

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.

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.

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

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.

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.