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Morning Briefing

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Monday, Apr 7 2025

Full Issue

Drugmakers Must Redo Research After FDA Finds Problems With Contractor

The FDA found "objectionable conditions" during a 2023 inspection of the Raptim Research facility in Nava Mumbai, India. An unspecified number of companies are affected. Raptim said on its website that the FDA recently inspected an unnamed facility and didn't find problems; it's unclear when that inspection occurred.

In a rare move, the U.S. Food and Drug Administration told an unspecified number of drug companies that studies used to support therapeutic equivalence of some of their medicines have been rejected due to false data generated by a contract research organization. The agency identified 鈥渟ignificant鈥 problems with data integrity and the way studies were conducted by Raptim Research, which had been hired by the drugmakers to test their medicines. The FDA expressed concern, specifically, about in-vitro studies, which are run to test biological processes. (Silverman, 4/4)

Bayer AG said it鈥檚 seeking a US Supreme Court review of litigation over the weedkiller Roundup, its latest effort to get beyond a mountain of legal woes. The German conglomerate asked the high court Friday to take its appeal of a 2023 verdict from a St. Louis trial in which a jury ordered Bayer鈥檚 Monsanto unit to pay $1.25 million in compensatory damages to cancer sufferer John Durnell, according to a statement. No punitive damages were awarded in the case. (Loh and Feeley, 4/4)

The benefits of taking drugs for attention deficit hyperactivity disorder outweigh the impact of increases in blood pressure and heart rate, according to a new study. An international team of researchers led by scientists from the University of Southampton found the majority of children taking ADHD medication experienced small increases in blood pressure and pulse rates, but that the drugs had 鈥渙verall small effects鈥. They said the study鈥檚 findings highlighted the need for 鈥渃areful monitoring鈥. (Topping, 4/6)

The World Health Organization (WHO) this week published two reports spotlighting gaps in adequate medicines and diagnostic tests for treating and detecting invasive fungal diseases, such as Candida auris, including a dearth of new drugs and drug candidates in advanced trials. More than 6.5 million fungal infections occur annually and cause 3.8 million deaths, according to WHO data. (Wappes, 4/4)

How tariffs might affect pharmaceuticals 鈥

The drug industry got a temporary reprieve on Wednesday when foreign-made medicines were exempted from President Trump鈥檚 far-reaching new tariffs. But Mr. Trump has been saying for weeks that he plans to impose tariffs specifically on pharmaceuticals, with the goal of shifting overseas production of medications back to the United States. He has said those levies could be 25 percent or higher. Drugmakers still expect tariffs targeting them to be announced soon. (Robbins, 4/4)

Marsha Cook of Las Vegas juggles multiple generic prescriptions on a tight budget. Any hint of a possible price hike hits hard. "I have high blood pressure, and when you even speak of it, I can feel like a stressor coming up in my neck," the 70-year-old Cook told CBS News. "I don't know what will be done. I don't know what I'll do."聽Cook worries that tariffs on pharmaceuticals would send her costs soaring even higher. (Gutierrez, 4/4)

In health care industry news 鈥

Emergency departments are in danger of closing without legislative intervention, according to a new report. Increased violence towards providers, declining reimbursement from payers and聽higher volumes of complex patients are endangering the future聽of emergency departments, nonprofit research organization聽Rand聽wrote聽in a report on Sunday.聽Rand聽said聽policymakers must pass聽legislation聽to help hospitals聽navigate the challenges that have surmounted for emergency departments over the years. (DeSilva, 4/6)

麻豆女优 Health News: Blockbuster Deal Will Wipe Out $30 Billion In Medical Debt. Even Backers Say It鈥檚 Not Enough

Underscoring the massive scale of America鈥檚 medical debt problem, a New York-based nonprofit has struck a deal to pay off old medical bills for an estimated 20 million people. Undue Medical Debt, which buys patient debt, is retiring $30 billion worth of unpaid bills in a single transaction with Pendrick Capital Partners, a Virginia-based debt trading company. The average patient debt being retired is $1,100, according to the nonprofit, with some reaching the hundreds of thousands of dollars. (Levey, 4/7)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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