Generic drug industry calls on FTC to dig into monopsony power among buyers, PBMs – Endpoints News

2022-04-02 09:55:08 By : Ms. Oya Leung

The generic drug industry group is calling on the Federal Trade Commission to crack down on monopsony power — or undue market control — exercised by drug buying groups’ purchasing of generic drugs, as well as anti-competitive practices of the middlemen known as pharmacy benefit managers.

On the buyers’ side, three big companies control 92% of all wholesale revenue, including Red Oak Sourcing (34%), Walgreens Boots Alliance (37%) and ClarusOne/McKesson (21%), according to the Association of Accessible Medicines.

“Excessive consolidation of power among the major Buying Groups presents the risk of exerting undue market power over generic suppliers, driving wholesale prices below marginal costs and reducing output, all of which can lead to producers exiting the market, or reducing production of unprofitable drugs,” AAM’s comment says.

This consolidation also can lead to shortages and incentivizes a race to use more low-cost manufacturing firms in regions where quality control issues may pose safety issues.

“Examination of available data from IQVIA shows that this consolidation has had significant deleterious effects, including: decisions to exit markets due to low margins; decisions not to launch (despite approval) due to low margins; large price declines on current products; harmonization of prices; and the scale-up to meet needs of a large buyer, followed by the need to drop prices to retain the volume in light of the created capacity,” AAM notes.

On the PBM side, AAM explains how again the top 3 companies control more than 80% of the market and they can control competition and are not required by law to disclose the rebates they receive from drugmakers or the difference between what they are paid by insurers to fill a prescription and how much they pay the pharmacy that fills it.

“Consolidation of PBMs has caused — and will continue to lead to — increases inpatient’s prices at the pharmacy, both through the implementation of various fees and rebates and by controlling access to networks, which limits options for patients,” AAM adds in its response to a request for public comment on how the agencies can modernize enforcement of the antitrust laws regarding mergers.

The FTC also recently put out a request in late February for comments on how PBMs’ practices affect drug affordability. Iowa Republican Sen. Chuck Grassley sent a letter last week to FTC chair Lina Khan, urging the commission to find common ground and closely examine how the PBM industry affects patients’ out-of-pocket expenses.

Disturbed or impaired sleep has been the subject of increased research attention in recent years, as both a primary disorder and in cases where disturbed sleep is a symptom of another disease. Disturbed sleep is common in people with arthritis, atopic dermatitis, Alzheimer’s Disease, Parkinson’s Disease, and many other conditions. Research is focused on measuring and diagnosing these sleep disorders, as well as the development of new treatments to improve sleep across a broad range of indications. Wearable devices provide a low-burden and remote approach to objectively quantify people’s sleep in their real life, often revealing meaningful insights that might not be available with polysomnography or self-report data. While sleep architecture and sleep staging are difficult to estimate with accelerometry alone, actigraphy is sensitive to treatment effects in previous studies of sleep disorders.1

In 2017, Ontario’s junior hockey team the Hamilton Bulldogs proposed a $252 million public spending plan to transform its home, the FirstOntario Centre, but the plan was squashed.

Fast forward to this week, when it seems that no matter how important the Bulldogs are to the community, the government is making a bet that cell and gene therapy manufacturing could be even more important. Ontario’s government unveiled plans for a $580 million new cell and gene therapy manufacturing center set to be built just a 10-minute drive from the stadium. And the government is footing much of the bill.

Hanging in the hallways of Eli Lilly’s neuroscience division are portraits of employee family members who have died from Alzheimer’s disease. The paintings are both tributes and inspiring reminders of the work Lilly employees are doing.

Now a social media effort is extending those stories beyond Lilly’s walls. Employees tell their personal stories as the children, grandchildren, caregivers and scientists connected to Alzheimer’s disease in a series of videos, six so far, with more to come.

Unlock this story instantly and join 137,600+ biopharma pros reading Endpoints daily — and it's free.

A former biotech researcher who said he was inspired by the hit TV show “Breaking Bad” to try to make ricin — a deadly poison — out of castor beans has been spared prison but sentenced to probation and home confinement for obstruction of justice.

Ishtiaq Ali Saaem, who holds a PhD in biomedical engineering and was identified as a former “director of advanced research” at an unnamed biotech company in Massachusetts, first caught the attention of FBI agents in 2015 when he placed an online order for 100 packets of castor beans, each containing eight seeds.

Unlock this story instantly and join 137,600+ biopharma pros reading Endpoints daily — and it's free.

Three months after BridgeBio’s TTR amyloidosis candidate suffered a major — and according to CEO Neil Kumar, “baffling” — Phase III fail that wiped out $4 billion in market cap, Endpoints News has learned that the company is swinging the budget axe, all while lying  low as best it can during the restructuring.

After receiving a call and tracking social media posts regarding a number of layoffs at BridgeBio, Kumar confirmed that the company has made cuts without specifying just how many.

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

Democrats and Republicans remained divided over how to lower the price of insulin, and on the House floor Thursday, Dems voted together with 12 Republicans to pass a bill to cap insulin prices at $35 per month, by a vote of 232-193 (and 6 didn’t vote). In the Senate, the picture isn’t so clear.

House Speaker Nancy Pelosi (D-CA) took to the floor on Thursday, explaining how the price of insulin has skyrocketed in recent years, with the top manufacturers pulling in record-breaking profits by charging the US significantly more than other countries.

Biohaven’s newest “celebrity” is also its top science leader.

CSO Charlie Conway is hosting its new unbranded video series “Ideahaven: Migraine Voices.” The monthly series launched last month will tap physicians, advocates and people living with migraine to cover topics from stigma to therapies.

However, the maker of Nurtec ODT well-known for its celebrity spokespeople isn’t totally stepping away from famous faces in the unbranded work. The first guest on Conway’s show is country music singer Allie Sealey, who talks about her migraine experience and about the song she wrote for the migraine community called “Not All in Your Head.”

Unlock this story instantly and join 137,600+ biopharma pros reading Endpoints daily — and it's free.

As the House preps to vote on a $35 monthly insulin cap later today (the Senate has plans for a vote next month too), there remain several outstanding questions on how the uninsured will be covered, how Democrats plan to pay for the cap and what the after-effects might be (i.e. will this cap be offset by premium increases?).

Kicking off discussion on the White House-backed cap Wednesday, the House Rules Committee split almost evenly along party lines. Democrats called for something to be done to stop people from rationing their lifesaving insulin due to price, while Republicans have sought other plans to lower insulin costs, including market-based solutions like biosimilars, which have struggled to take off so far, or providing PBM rebates directly to patients.

Sage Therapeutics on Friday uncorked what it sees as some positive — albeit early, and unblinded — data suggesting its lead neuropsychiatric drug led to improvements in Alzheimer’s patients. Now the real test will be seeing if those results hold up in a larger, blinded group.

“The study was designed first and foremost for safety, tolerability and PK,” Aaron Koenig, Sage’s VP of early clinical development, told Endpoints News. 

Unlock this story instantly and join 137,600+ biopharma pros reading Endpoints daily — and it's free.

Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

If you're already an Endpoints subscriber, enter your email below for a magic link that lets you log in quickly without using a password. Please note the magic link is one-time use only and expires after 24 hours.

We'll e-mail you a link to set a new password. Please note this link is one-time use only and is valid for only 24 hours.

ENDPOINTS NEWS Daily at 11:30 AM ET

EARLY EDITION Daily at 7:15 AM ET

ENDPOINTS PHARMA Daily at 2 PM ET

ENDPOINTS MARKETING RX Tue at 2 PM ET

ENDPOINTS FDA+ Wed at 2 PM ET

ENDPOINTS MANUFACTURING Thu at 2 PM ET

ENDPOINTS WEEKLY Sat at 6 AM ET