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The Biden administration rolled out new guidance to drugmakers for meeting a new requirement to dole out rebates if their prices on Medicare Parts B and D go above inflation...The guidance...implements a key part of the Inflation Reduction Act passed last year. Drug companies had to start paying rebates for raising prices past inflation back in January, with the amounts going back to Medicare...“We are fighting to rein in the excessive cost of skyrocketing prescription drug prices, and now drug companies that increase their prices faster than the rate of inflation will have to pay rebates back to the Medicare Trust Fund,” said HHS Secretary Xavier Becerra in a statement...READ MORE

In 2016, a blockbuster drug called Humira was poised to become a lot less valuable...Through its savvy but legal exploitation of the U.S. patent system, Humira’s manufacturer, AbbVie, blocked competitors from entering the market. For the next six years, the drug’s price kept rising. Today, Humira is the most lucrative franchise in pharmaceutical history...Next week, the curtain is expected to come down on a monopoly that has generated $114 billion in revenue for AbbVie just since the end of 2016. The knockoff drug that regulators authorized more than six years ago, Amgen’s Amjevita, will come to market in the United States, and as many as nine more Humira competitors will follow this year from pharmaceutical giants including Pfizer. Prices are likely to tumble...READ MORE

Gigi Jordan, the millionaire pharmaceutical executive convicted of manslaughter in the death of her 8-year-old son, was found dead inside her Brooklyn home in what cops are investigating as a possible suicide...Her body was found around 12:30 a.m. Friday... just hours after US Supreme Court Justice Sonia Sotomayor issued an order that was expected to send Jordan, 62, back to prison...Jordan was accused of force-feeding her autistic son, Jude Mirra, a lethal dose of pills in February 2010...READ MORE

In the first year of the pandemic, 19 rural hospitals closed their doors. Yet in the years since, only six have. What these historic lows might suggest is deceptive, experts caution...In the decade leading up to 2020, the average margins of rural hospitals were on a downward trajectory, with more than 130 closing in that time. During the COVID-19 pandemic, existing challenges with limited staff and capacity got worse. But thanks to pandemic relief funds, rural hospitals received billions of dollars to offset mounting costs...With dwindling funds, rural hospitals are expected to return to pre-pandemic levels of profitability...READ MORE

As rescue efforts continue in the wake of a cataclysmic earthquake on the border of Turkey and Syria, drugmakers near and far are rushing to offer aid...Novartis and its generics arm Sandoz are putting up $1 million for the cause. At present, the companies are working to identify the right partners to “make sure this support gets to those most in need,”...Novartis also said it's in close contact with its local team to ensure the well-being of some 1,600 staffers and their families in the region...Bayer...will donate a total of 1.5 million euros to the affected regions...READ MORE

The agency will kick off discussions on how it will negotiate Medicare drug prices in the spring and publish the first 10 drugs selected by Sept. 1, 2023...The U.S. Department of Health and Human Services...released its timeline for negotiating prices on an initial tranche of Medicare drugs, a new power granted the agency by last year’s Inflation Reduction Act...Under the law, Medicare can negotiate prices for top-selling drugs that have no competition, starting with 10 in 2026 and rising to a total of 60 by 2029. But the law didn’t fully detail the process by which that will happen...READ MORE

The Food and Drug Administration could require drugmakers seeking speedy approvals of new treatments to begin confirmatory testing before gaining the agency’s clearance under legislation before Congress...the legislation would also expedite the process for withdrawing conditionally approved drugs...Contained in a massive, year-end federal spending bill, the provisions instruct the FDA to convene a seven-member council of agency officials to develop consistent policies and practices around accelerated approvals...READ MORE

Sixteen states have banned a pharmacy benefit management practice that involves not counting the value of drug copay assistance from manufacturers toward patient deductibles...Drugmakers use copay assistance programs to shield patients from out-of-pocket expenses — and build market share for their products in the process. But pharmacy benefit managers have cried foul, saying the copay programs undercut formularies and wind up increasing the use of expensive drugs that are not any better than less expensive ones. They have pushed back with “copay adjustment programs,” especially “copay accumulators,” which are designed to blunt the effect of the copay assistance programs by not counting their value toward patient deductibles...READ MORE

California is suing major drug manufacturers and pharmacy benefits managers for allegedly leveraging their market power to overcharge patients for insulin...The state filed suit...against drug manufacturers Eli Lilly, Novo Nordisk, and Sanofi, along with major PBMs CVS Caremark, Cigna’s Express Scripts and UnitedHealth Group’s OptumRx...The lawsuit alleges that the drugmakers and PBMs worked together to drive up the price of insulin through illegal and deceptive business practices in violation of California’s Unfair Competition Law...READ MORE

In yet another turn in the high-profile Zantac litigation, Sanofi and Pfizer agreed to settle a case set for trial in California...which comes after a U.S. District Judge ruled against the plaintiffs in the federal group of cases against the companies and others. Earlier this month, that ruling took out about 50,000 Zantac claims off the board.As for the California settlement, that lawsuit came in California Superior Court for Alameda County...The financial terms of the agreement were not revealed...READ MORE