Does biotech have a drug pricing problem?

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Sponsored by       Happy New Year, D.C. Diagnosis readers! Hope you all had a happy and safe holiday season. I’m so excited for all of the reporting we are going to bring you this year … so much so that I bombarded my editor with story ideas at 8 a.m. this morning. (Sorry, Erin!) It’s never too late to add a story idea to that list. Hit me with your best one. I’m at nicholas.florko@statnews.com.  Who is really to blame for pharma’s drug pricing problems?  Drug pricing advocates were rabid Monday over the news that biopharma companies rang in the new year by hiking the prices of more than 400 drugs, according to new analysis from GoodRx. But most of the companies guilty of jacking their prices aren’t the household names you’d expect. Some of the biggest price hikes came from biotech companies like Recordati Rare Diseases, United Therapeutics, and Leadiant Biosciences.  At a time when Washington is within striking distance of cracking down on how much drug makers can hike their prices each year, some of these decisions seem like serious PR disasters.  Recordati’s biggest price hike, for example, was for a drug that treats premature infants at risk of a congenital heart defect, known as patent ductus arteriosus.  Neoprofen now retails for nearly $3,000 — a 10% hike. Recordati took the same price hike in 2021 and 2020, according to GoodRx data.  United Therapeutics also took a 9.9% price increase on its childhood cancer medication, Unituxin, following a 9.9% increase in 2021. The drug now retails for $14,349 per vial, according to Elsevier's Gold Standard Drug Database.  Leadiant even hiked the price of a 50-year old cancer drug, Matulane, by more than 15% – making it one of the few price hikes over 10% so far this year. The drug now retails for $11,969, according to Elsevier.  Pharma isn’t blameless, however. Pfizer took price hikes for roughly 100 drugs, including a 16.8% price hike for its injectable hydrocortisone product, which a spokesperson chalked up to the “rising costs of components and materials, as well as our investments to upgrade our manufacturing facilities to produce this medicine.” (That drug still retails for less than $20.) But the currently available data suggests that many pharma giants took much smaller price hikes compared to some of their biotech counterparts. Gilead, for example, took 5.6% price hikes for all 11 of the drugs it priced up. Sanofi’s price hikes varied from 5.2% to 2.4%.  This could all change, however.  Several major drug makers aren’t included at all in GoodRx’s list, and the company told STAT that they expect data on price hikes to trickle in throughout the month.  For more on this week’s price hikes check out my colleague Ed Silverman’s story here.  Will 2022 be a better year for the FDA's vaccine center? Its top official hopes so It’s no secret that the FDA’s biologics center has had a rough two years. Its top vaccine officials quit during the heart of the pandemic, and have taken to writing op-eds not-so-thinly criticizing the agency’s recent moves. It’s had to push off some of its typical work in favor of reviewing vaccines. Vaccine staff have been working basically nonstop for more than a year – Peter Marks, the head of CBER, even said that reviewers in 2020 were “eating turkey sandwiches on Thanksgiving while reviewing documents.” Will 2022 be better? Marks hopes so. STAT spoke to the CBER director at length about his centers’ priorities for 2022 and how it will try to make this year the year it works “alongside the pandemic, as opposed to being dominated by the pandemic.”  The year won’t be without challenges, however. Even Marks says that it could take six to 12 months for certain projects to get back into full swing — like having regular meetings with cell and gene therapy developers. But he insists he’s only modestly worried about what the next year has in store.  Check out the new Q&A for STAT here. This state lawmaker is returning checks from Pfizer and other vaccine makers — but not for the reason you’d expect  Ohio state Rep. Beth Liston isn’t the first lawmaker to return a check from drug makers, but she’s one the first to do so out of fear that accepting the cash would it make it harder for her to impartially tout the benefits of vaccination against Covid-19, my colleague Rachel Cohrs writes in a new story for STAT.  The checks were small – $300 from Pfizer and $250 from Johnson & Johnson — but Liston, a Democrat at the center of Ohio’s fierce debate over vaccination, told Rachel that she feared accepting the checks would only prompt anti-vaccine activists to accuse her of pushing the vaccines for profit.  Check out Rachel’s fascinating new story here.  Sponsor content by PhRMA Why do politicians want to restrict future lifesaving medical advances? It’s government price setting that does little to address patient affordability and will decimate the US competitive ecosystem that has brought hope to so many Americans in the form of new medical advances where before there were none. This plan will result in negative consequences for the patients with the most need. Read more. As Covid-19 supplies run low, Republicans crank up the heat on Biden   Sens. Richard Burr (R-N.C.) and Roy Blunt (R-Mo.), two top Republicans with oversight over the federal health department, sent a scathing letter to the Biden administration Monday demanding answers as to why Americans still can’t find Covid-19 tests, despite Congress allocating more than $80 billion for Covid-19 testing. The letter doesn’t pull any punches. It blames the lack of testing supply on “a … fundamental lack of strategy and a failure to anticipate future testing needs by the administration.” Florida Governor Ron Desantis separately pressured the Biden administration Monday to allow states to directly order monoclonal antibody treatments from drug makers amidst stockpiling of the treatments by the federal government in response to the Omicron variant. “The only thing holding us back is the insufficient supply of treatment from the federal government,” DeSantis said in a press conference Monday. (An HHS spokesperson told STAT that "Florida should have a strong supply of [these products] on hand – and more than most other states" and that the federal government has sent roughly 30,000 antibody treatments to the state over the last three weeks.) But both efforts underscore that the exponential surge in Covid-19 cases is causing a political headache for the Biden administration. It’s an ironic situation, given Biden’s work to stand up a massive federal Covid-19 response that included spending billions on shoring up supplies for vaccines, tests, and treatments.  STAT stories you may have missed Experts say the U.S. has a ways to go to get through the Omicron surge. Here, STAT outlines what Omicron is already teaching us as this phase of the pandemic plays out. And here, STAT’s Helen Branswell shares the 10 lessons she’s learned from the pandemic.  Our 3 biggest questions about the Biden administration’s Covid response.  What racism in medicine takes from us.  The challenges to implementing the requirements of the No Surprises Act should be viewed as an opportunity to bring health care into the consumer age. The FDA is gearing up for some of its most monumental decisions in recent memory. Here are the 3 we're watching in 2022. HHS appeals rulings over drug discount program just as AbbVie is the latest to cut discounts. Thanks for reading! More next week, @NicholasFlorko Continue reading the latest health & science news with the STAT app Download on the App Store or get it on Google Play Tuesday, January 4, 2022       1 Exchange Pl, Suite 201, Boston, MA 02109 ©2022, All Rights Reserved. I no longer wish to receive STAT emails Update Email Preferences | Contact Us | View In Browser