FDA Investigation Finds Problems At Indian Drug Factory Tied To Recalls

The Food and Drug Administration has found problems at an Indian factory that makes generic drugs for American patients, including one medication that was manufactured there and has been linked to at least eight deaths, federal records show.

The agency inspected the factory after a ProPublica investigation in December found that the plant, operated by Glenmark Pharmaceuticals, was responsible for an outsized share of recalls for pills that didn’t dissolve properly and could harm people. (Callahan, 3/20)

UnitedHealth Group Inc.’s drug-benefits unit is starting to reimburse pharmacies more for dispensing brand-name medicines to address longstanding complaints that expensive prescriptions are losing money for drugstores.

Pharmacy benefit managers have traditionally compensated pharmacists more for cheaper generic medicines to encourage their use, said Patrick Conway, chief executive officer of UnitedHealth’s Optum Rx unit. But generic adoption has plateaued, and Conway said the old system discouraged some pharmacies from stocking newer branded drugs like diabetes and weight-loss shots. (Swetlitz and Tozzi, 3/20)

Optum Rx is shifting its payment models to better meet the needs of pharmacies and consumers, the pharmacy benefit manager announced Thursday. The company said it will shift to a cost-based model, which will better align with “the costs pharmacies may face due to manufacturer pricing actions.”

The PBM expects the change to be a positive one for the more than 24,000 independent and community pharmacies it works with, along with its members. (Minemyer, 3/20)

Negotiations to set prices Medicare will pay for the original branded version of etanercept, Enbrel, should bring the government some genuine savings, and may indirectly make it more affordable for everyone, a new analysis indicated.

Talks between CMS and drugmaker Amgen authorized under the Inflation Reduction Act (IRA), former President Biden’s signature legislative success, led to an agreement that Medicare would pay $2,355 for a 30-day supply starting next year, approximately one-third of its 2023 list price of $7,106. (Gever, 3/20)

The Food and Drug Administration cleared Alnylam Pharmaceuticals’ treatment for a progressive heart condition Thursday, setting it up to compete with therapies from BridgeBio and Pfizer. (Chen, 3/20)

CEPI, the Coalition for Epidemic Preparedness Innovations, yesterday announced a $43.5 million deal with pharmaceutical giant AstraZeneca to advance the development of a novel antibody that could reduce costs and improve access to monoclonal antibody treatments. The antibody is called VHH (Variable Heavy domain of a Heavy chain-only antibody) and will be designed to target four potential pandemic influenza virus strains—H1, H3, H5 and H7. (Soucheray, 3/20)

A common blood test may miss ovarian cancer in some Black and Native American patients, delaying their treatment, a new study finds. It’s the latest example of medical tests that contribute to health care disparities. Researchers have been working to uncover these kinds of biases in medicine.

Recently, the Trump administration’s crackdown on diversity, equity and inclusion has jeopardized such research as universities react to political pressure and federal agencies comb through grants looking for projects that violate the president’s orders. (Johnson, 3/20)