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.
Stat:
FDA Tells Drugmakers To Redo Studies Over Data Integrity Issue
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 “significant” 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)
Bloomberg:
Bayer Asks High Court To Take $1.25 Million Roundup Appeal
Bayer AG said it’s 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’s 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 Guardian:
Benefits Of ADHD Medication Outweigh Health Risks, Study Finds
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 “overall small effects”. They said the study’s findings highlighted the need for “careful monitoring”. (Topping, 4/6)
CIDRAP:
WHO Highlights Need For Better Drugs, Diagnostics For Deadly Fungal Infections
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 —
The New York Times:
Trump’s Next Tariffs Target Could Be Foreign-Made Pharmaceuticals
The drug industry got a temporary reprieve on Wednesday when foreign-made medicines were exempted from President Trump’s 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)
CBS News:
Threat Of Future Tariffs On Pharmaceutical Imports Alarms Health Care Community
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." Cook worries that tariffs on pharmaceuticals would send her costs soaring even higher. (Gutierrez, 4/4)
In health care industry news —
Modern Healthcare:
Emergency Departments Risk Closing Over Pay, Overcrowding: Rand
Emergency departments are in danger of closing without legislative intervention, according to a new report. Increased violence towards providers, declining reimbursement from payers and higher volumes of complex patients are endangering the future of emergency departments, nonprofit research organization Rand wrote in a report on Sunday. Rand said policymakers must pass legislation to help hospitals navigate the challenges that have surmounted for emergency departments over the years. (DeSilva, 4/6)
KFF Health News:
Blockbuster Deal Will Wipe Out $30 Billion In Medical Debt. Even Backers Say It’s Not Enough
Underscoring the massive scale of America’s 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)
