Ama­zon sub­sidiary Pill­Pack reach­es a set­tle­ment with US gov­ern­ment and will have to shell out over $5.6M

Ama­zon’s on­line phar­ma­cy has set­tled a law­suit in New York af­ter al­le­ga­tions of over­billing for the life­sav­ing drug in­sulin.

The set­tle­ment re­solves al­le­ga­tions that the phar­ma­cy, known as Pill­Pack, im­prop­er­ly billed gov­ern­ment health­care pro­grams like Medicare and Med­ic­aid for more in­sulin pens than pa­tients need­ed ac­cord­ing to their pre­scrip­tions, and for false­ly un­der-re­port­ing the days in­sulin sup­plies were dis­pensed.

Un­der the set­tle­ment, Pill­Pack has agreed to pay ap­prox­i­mate­ly $5.6 mil­lion to the US gov­ern­ment and over $175,000 to oth­er states that were fraud­u­lent­ly over­billed for in­sulin. As a part of the set­tle­ment, Pill­Pack has al­so ad­mit­ted and ac­cept­ed re­spon­si­bil­i­ty for cer­tain con­duct, in­clud­ing that it dis­pensed in­sulin pens that ex­ceed­ed im­posed days-of-sup­ply lim­its.

Dami­an Williams

“Phar­ma­cies are trust­ed to pro­vide ac­cu­rate in­for­ma­tion to Gov­ern­ment health­care pro­grams and to pre­vent waste when dis­pens­ing med­ica­tions to pa­tients. Pill­Pack abused this trust by dis­pens­ing in­sulin re­fills long be­fore pa­tients need­ed them and by false­ly re­port­ing the days of sup­ply of in­sulin ac­tu­al­ly dis­pensed to pre­vent its claims for re­im­burse­ment from be­ing de­nied,” US at­tor­ney Dami­an Williams said in a state­ment.

Ac­cord­ing to the gov­ern­ment, Pill­Pack sought re­im­burse­ment for in­sulin pens, but it was re­quired to re­port the quan­ti­ty dis­pensed and the days of sup­ply.

In­stead of ac­cu­rate­ly re­port­ing the days of sup­ply and con­tact­ing the Cen­ters for Medicare and Med­ic­aid Ser­vices, the gov­ern­ment al­leged that Pill­Pack would dis­pense and bill for the full car­ton and re­duce the days of sup­ply re­port­ed to the gov­ern­ment pro­gram to con­form to the lim­it. As a re­sult, for those claims, Pill­Pack re­port­ed days-of-sup­ply da­ta to GH­Ps that were dif­fer­ent from, and low­er than, the days-of-sup­ply that should have been re­port­ed.

From April 2014 through Nov. 2019, Pill­Pack’s gen­er­al prac­tice was to dis­pense in­sulin pens to pa­tients us­ing full car­tons. Pill­Pack would dis­pense and bill for the full car­ton and false­ly un­der­re­port the days of sup­ply to make it ap­pear that the dis­pens­ing did not vi­o­late the pro­gram’s days-of-sup­ply lim­it.

This prac­tice of un­der-re­port­ing al­so led Pill­Pack to dis­pense pre­ma­ture re­fills to pro­gram ben­e­fi­cia­ries, which led to fre­quent­ly dis­pensed in­sulin pen re­fills days or weeks be­fore pa­tients need­ed them ac­cord­ing to their pre­scrip­tions.

Pill­Pack, which was ac­quired by Ama­zon in 2018, was brought un­der Jeff Be­zos’ fold dur­ing a time when he, Berk­shire Hath­away and JP Mor­gan were try­ing to think up ways to dis­rupt the US health­care sys­tem. While Pill­Pack was not a part of that ven­ture, Ama­zon in­her­it­ed Pill­Pack’s phar­ma­cy li­cens­es in all 50 states, be­com­ing a play­er in the phar­ma­cy de­liv­ery ser­vice.

How­ev­er, Pill­Pack’s set­tle­ment al­so comes at a time when the av­er­age re­tail price for in­sulin has risen dra­mat­i­cal­ly over the years, over 54% from 2014 to 2019, ac­cord­ing to GoodRx.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

BREAK­ING: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,300+ biopharma pros reading Endpoints daily — and it's free.

Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,300+ biopharma pros reading Endpoints daily — and it's free.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,300+ biopharma pros reading Endpoints daily — and it's free.

Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

FDA's ad­vanced ther­a­pies of­fice pro­vides more clar­i­ty on gene ther­a­py CMC con­sid­er­a­tions

As the Office of Tissue and Advanced Therapies (OTAT) transforms into the Office of Therapeutic Products (OTP), with new user fee funds and “super office” status, the department focused on cell and gene therapies also opened its doors to a town hall Thursday offering clarification on guidance and regulations for manufacturers.

Some of the major concerns from manufacturers were the CMC considerations between first-in-human studies and late-phase studies supporting a marketing approval.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 151,300+ biopharma pros reading Endpoints daily — and it's free.

Sens. Rand Paul (R-KY) and Cory Booker (D-NJ) (Olivier Douliery/Sipa USA (Sipa via AP Images)

Sen­ate pass­es bill to re­work an­i­mal test­ing re­quire­ments for drug de­vel­op­ers

The US Senate passed via unanimous consent on Thursday afternoon a bipartisan bill that would alter a federal mandate for animal testing on new drugs, but stops short of removing animal testing entirely.

Touted as a much-needed modernization of FDA’s rules, co-sponsor Sens. Rand Paul (R-KY) and Cory Booker (D-NJ) have said the bill will stop lots of needless suffering of animals.