At issue is a maneuver called alternative funding, which a growing number of drugmakers contend exploits their charitable programs. Basically, a plan sponsor excludes certain expensive drugs from coverage and taps an outside vendor to help patients obtain the medicines for free from patient assistance programs run by drug makers or foundations.

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taxes, according to a memo by a U.S. Senate Committee.

Specifically, the average effective tax rate for seven of the biggest drugmakers fell by 40% — dropping to 11.6% in 2020, down from 19.6% in 2016. In 2017, a new law was passed that permanently lowered corporate tax rates from 35% to 21%. Meanwhile, many of the largest pharmaceutical companies reported that 75% of their profits came from overseas.

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Pharmalot — the rotation will include this, this and this. And what about you? Given the spate of tumultuous news these past few days, perhaps spending time by calming ocean waters or in the solitude of a woodsy area is in order. Or you could zone out and binge-watch something fanciful on the telly. Or perhaps this is an opportunity to plan the rest of your life. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

Genentech said an internal review of misconduct allegations concerning a landmark 2009 paper co-authored by Marc Tessier-Lavigne, a former top executive at the company and currently president at Stanford University, did not find evidence of fraud or intentional wrongdoing, STAT reports. But the review also points to another previously undisclosed case of scientific misconduct by a post-doctoral researcher in Tessier-Lavigne’s lab. The findings come after the university newspaper reported former Genentech employees claimed an internal review uncovered falsified data and that the neuroscientist tried to keep that information quiet.

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As always, we are quaffing some cups of stimulation — roasted coconut is our choice du jour — and assembling some tidbits for your pleasure. So, time to get cracking. Hope you have a smashing day, and do stay in touch. We always enjoy your tips and insights. …

A U.S. Food and Drug Administration advisory panel concluded that a treatment developed by Biogen for a rare, genetic form of ALS should be approved, despite unanswered questions about its benefit to patients, STAT reports. The panel voted 9-0 that the “totality of the evidence” was sufficient to support conditional approval of the Biogen drug, called tofersen. By a 5-3 vote (with one abstention) the panel concluded the tofersen data, including from a failed clinical trial, were not sufficiently convincing to support full approval. The mixed votes suggest the FDA will likely grant accelerated approval, which would allow Biogen to market the drug while it collects additional data to confirm its benefit.

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The maneuver goes by different names — it’s sometimes called a specialty carve out, or alternative funding – but relies on exploiting charitable programs. It works like this: a health plan sponsor excludes certain expensive specialty medicines from coverage and taps an outside vendor to help patients obtain the drugs for free from patient assistance programs run by drugmakers or foundations.

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Our choice today is mocha marshmallow. No prescription is required, so no rebates must be paid or tracked. Meanwhile, here is the latest menu of tidbits to help you on your way. Have a wonderful day, and please do stay in touch. Postcards and telegrams are welcomed. …

The Biden administration will fine drugmakers that hiked prices faster than the inflation rate on 27 medicines administered in physician offices, STAT notes. Pfizer had the most drugs on the list of any manufacturer, with five. AbbVie’s blockbuster rheumatoid arthritis drug, Humira, is on the list. Gilead Sciences, Endo International, Leadiant Biosciences, and Kamada had two drugs each. The fines are some of the first major changes to the U.S. drug pricing landscape since the Inflation Reduction Act became law. But White House officials said they intend to delay actual invoices for the price hikes until 2025.

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Meanwhile, do keep us in mind if you hear anything saucy. Our in-basket has been outfitted to accept postcards and telegrams. Have a smashing day. …

Eli Lilly says that all doses of its new Mounjaro diabetes drug are now available after social-media enthusiasm about weight-loss benefits sparked a two-month-long shortage, Bloomberg News tells us. The drug was approved in the U.S. last May to help people with type 2 diabetes control their blood sugar levels. Mounjaro is part of a group of diabetes treatments known as GLP-1s that have shown outsize potential for weight loss. Some of the drugs, including Mounjaro, are being recommended by doctors for weight loss even though they have not been explicitly approved as an obesity treatment in a common practice known as off-label prescribing.

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In making its case, the Pharmaceutical Accountability Foundation argued AbbVie allegedly overcharged the Dutch health care system by up to $1.2 billion by “abusing” its position in the marketplace and keeping prices high. The company sold approximately $2.3 billion worth of Humira in the Netherlands between 2004 and 2018, when its patents provided a monopoly.

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Humira has been the world’s best-selling medicine since it arrived on the market in 2002. Now, it is finally getting competition with the release of Amgen’s biosimilar drug, Amjevita. Humira’s main patent expired in 2016, but a byzantine patent saga has kept other drugmakers from offering their own version of the monoclonal antibody used to treat conditions such as rheumatoid arthritis and Crohn’s disease.

In this video, STAT senior writer and Pharmalot columnist Ed Silverman breaks down the convoluted world of pharmacy benefit managers, formularies, and a legal maneuver called “patent thicketing” that controls how much patients pay for this beneficial treatment.

Although gray skies are hovering over the Pharmalot campus, our spirits remain sunny because, as the Morning Mayor taught us, “Every brand new day should be unwrapped like a precious gift.” And so, we are foraging for interesting stories and quaffing cups of stimulation, as you might have guessed. Our choice today is salted caramel mocha. And you? Is your schedule filled with meetings and deadlines and what-not? To help you along, here are some tidbits. Hope you conquer the world, and do keep us in mind when you see something fascinating. …

Pharmaceutical executives are ready to make deals, The Wall Street Journal says. Executives at Pfizer, Merck, and Novartis are looking for promising drugs to add to their pipelines and replenish sales as top-selling products lose patent protection in the coming years. Meanwhile, AbbVie is lifting a self-imposed $2 billion limit on the size of deals it would do to add more products. The acquisitions could help the companies add new sales to aging line-ups and suggest this year could be a busy one for industry dealmaking. The $88 billion in total deal value last year, involving 75 biopharma tie-ups of at least $100 million, was the lowest since 2017, according to Ernst & Young.

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