FDA could get 30-day warrant to crack down on open access to hearing aids


Seemingly dissatisfied with the Food and Drug Administration’s slow pace in authorizing over-the-counter hearing aid purchases, two senators are threatening the FDA with a bill. Meanwhile, costs and supply chain issues are pushing people toward refurbished walkers and wheelchairs.

Stat: Warren and Grassley threaten to slap the FDA with a 30-day deadline for over-the-counter hearing aid rules

A bipartisan duo of senators are done waiting for the Food and Drug Administration to finalize a rule that will finally allow companies to sell over-the-counter hearing aids. Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) introduced a bill on Friday that would require the Biden administration to release long-blocked FDA regulations on hearing aids within 30 days. The new bill is the latest sign of frustration in Washington over the FDA’s work on access to hearing aids; Grassley and Warren passed legislation to pave the way for cheaper over-the-counter devices five years ago, in 2017. (Florko, 4/8)

In other medical device news —

KHN: Refurbished Walkers and Wheelchairs Fill Gaps Created by Supply Chain Issues

Michele Lujan needed a wheelchair for her 52-year-old husband who had been hospitalized with covid-19. But she had lost her job and money was tight. Insurance wouldn’t cover the cost, and she didn’t see the point of buying something to meet a temporary need. So she turned to a loan closet not far from her home in the Denver suburb of Highlands Ranch. At the South Metro Medical Equipment Loan Closet, crutches hung from the walls, lap scooters lined the floor, and shower seats and toilet risers overflowed the shelves. She found a wheelchair that she could borrow for free. (Ruder, 4/11)

In the news from the pharmaceutical industry —

USA Today: Breakthrough leukemia treatment offers ‘moment of hope’ in fight against solid tumors

On Wednesday, 5-year-old Mary Stegmueller will reach a milestone. She will have survived her expected life expectancy. Twice. At the age of 4, Mary, an exuberant animal lover from Northglenn, Colorado, had nine months to live. A devastating brain tumor was extending its tentacles through his brainstem, the area that controls breathing, heart rate and other essential functions. The tumor, called diffuse intrinsic pontine glioma, strikes 300 to 400 Americans each year, mostly children, and several thousand more worldwide. (Weintraub, 4/10)

Stat: RNAM Vaccine Amplification May Help CAR-T Therapy Treat Solid Cancers

While CAR T therapy has cured some people with blood cancers, this form of immunotherapy has so far produced poor results for solid tumors like lung or kidney cancer. But a new early-stage clinical trial presented at the American Association for Cancer Research (AACR) conference on Sunday suggests that CAR T cells may be able to shrink some solid tumors – provided they are boosted by a mRNA vaccine from BioNTech. (Chen, 4/10)

NPR: CDC assesses new opioid prescribing guidelines amid controversy over old ones

Doctors will soon have new guidance from the Centers for Disease Control and Prevention on how and when to prescribe opioids for pain. These guidelines – currently under review in draft form – will serve as an update to the agency’s previous advice on opioids, published in 2016. This advice is widely accused of having harmful consequences for patients suffering from Chronic Pain. Federal officials have acknowledged that their initial guidelines were often misapplied; it was meant to serve as a roadmap for clinicians to make difficult decisions about opioids and pain, not as a set of rigid rules. (Peter, 4/9)

Statistic: Aduhelm’s coverage restrictions could shape the future of accelerated approval

Where is Accelerated Approval going? Amid the hubbub over new Medicare coverage restrictions for Alzheimer’s treatments, one key issue may not be fully appreciated: There is now a bona fide denial against accelerated approval. , a controversial strategy used by regulators and companies to bring new drugs to market faster than usual. At first glance, this suggests potentially wider – and sobering – implications for the pharmaceutical industry and patients, as they may one day have to wait longer for new drugs to roll out of the proverbial door. (Money Man, 4/9)

KHN: Journalists Discuss Insulin Costs and Ethical Issues Surrounding North Carolina Rehab Program

KHN Midwest correspondent Bram Sable-Smith discussed insulin costs on NBC’s LX on April 6. in North Carolina which offers free room and board to convalescents in exchange for free work – on WUNC’s “WUNC Politics” podcast on April 6. (4/9)

As well –

Houston Chronicle: Doctor Completes First TULSA Procedure Performed at Houston Hospital

The story was made on Friday as a local doctor performed a procedure that had never been performed at a Houston hospital. Advanced prostate cancer treatment called ultrasound transurethral ablation is now offered at Houston Methodist Willowbrook, the hospital announced this week. “This is the first time the TULSA procedure has been performed in a Houston-area hospital, providing patients with prostate cancer or an enlarged prostate with a meaningful opportunity to maintain their lifestyle. “said Steven Sukin, MD, in the announcement. (Feuk, 4/8)

AP: Can cancer blood tests hold the promise of saving lives?

Joyce Ares had just turned 74 and was feeling great when she agreed to donate a blood sample for research. So she was surprised when the screening test came back positive for signs of cancer. After a new blood test, a PET scan and a needle biopsy, he was diagnosed with Hodgkin’s lymphoma. “I cried,” said the retired real estate broker. “Just a few tears and I thought, ‘OK, now what do we do? It searches for cancer by checking DNA fragments released by tumor cells. (Johnson, 4/11)

Stat: Lighting up cancer cells with PH-activated nanoparticles

On a screen at the American Association for Cancer Research (AACR) conference here on Saturday, one of Jinming Gao’s graduate students squirted acid into a test tube in their South Medical Center lab. west of the University of Texas. Almost immediately, the liquid at the end of the tube began to glow like a white star under infrared light, visible on a surgical monitor. When the student squirted it with a base, the light went out. Inside the tube is a nanomaterial that, at the molecular level, looks like a bunch of strings – polymers – organized into a sphere. Gao, a biomedical engineer working in cancer applications and a member of the Harold C. Simmons Comprehensive Cancer Center, calls it a micelle, and it has several unique properties that experts say other labs have struggled to achieve. . In particular, micelles can carry a therapeutic load and deliver it only at the precise acidity of a cancerous tumor. (Chen, 4/10)

Stat: Seeing the benefits of a fully sequenced new genome could take years

Genomics has made significant inroads into mainstream medicine – DNA data is now commonly used to tailor cancer treatments, for example. But the reference genome created by the Human Genome Project, which has underpinned so many scientific and clinical advances over the past 20 years, was never truly complete. Technology at the time could not fix the remaining 8% – large gaps spread across the genome that together amounted to missing an entire chromosome. If you imagine a map of the world, it’s about the size of Africa. This means that doctors have always flown with a significant blind spot. If a patient has a disease-causing mutation in one of these missing or error-containing parts of the reference genome, there is no way to find it. That’s why there was so much excitement last summer when a team of nearly 100 scientists announced they had deciphered those pesky, previously impossible-to-map regions and unveiled the first-ever truly complete human genome. (Molténi, 4/8)

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


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