U.S. federal government agency recoveries under the False Claims Act (FCA) are down slightly in the first half of 2023 relative to the first half of 2022, but that doesn’t mean companies in the life sciences can afford to let their guard down. The Senate is examining two pieces of legislation that would significantly amplify the risk for device and drug makers, including a Senate bill that would eviscerate the materiality standard as set by the U.S. Supreme Court in Escobar.
The U.K. National Institute for Health and Care Excellence (NICE) is considering a coverage policy for stenting of the carotid arteries in asymptomatic patients, a change that could give these stents a significantly larger patient population in the U.K.
When it comes to recommending reforms for the U.S.’ 30-year-old 340B Drug Discount Program, there’s one thing drug manufacturers and hospitals agree on – pharmacy benefit managers (PBM) and other middlemen should not be profiting from a program that’s intended to help uninsured and vulnerable patients gain access to affordable prescription drugs or other health care services.
In game-changing news for parents of children with cerebral palsy, researchers demonstrated significant clinical improvement in the sensorimotor function of children who underwent sessions using Spinex Inc.’s Spinal Cord Innovation in Pediatrics (Scip) therapy. With current treatment options limited to physical therapy, medication and/or surgery, Parag Gad, co-founder and CEO of Spinex, told BioWorld he believes that Scip therapy “can be the new standard of care” for children with cerebral palsy.
The U.S. FDA recognized several new standards for sterilization of medical devices as part of an effort to reduce the use of ethylene oxide (EtO) for this purpose. While the recognition may stimulate adoption of alternative methods, Congress is applying yet more pressure on the EPA to act more decisively in regulating EtO, thus amplifying pressure on a system that device makers believe is already under stress.
With more drugs for Alzheimer’s disease (AD) gaining FDA approval and an aging population at increased risk of dementia, the need for AD diagnostics is only going to grow. An estimated 6.7 million Americans live with Alzheimer’s today, with that number projected to hit 14 million by 2060, according to the CDC.
While U.S. politics continues to delay Senate confirmation of the NIH director, other crucial positions at the agency that don’t require Senate action are being filled. Acting NIH Director Lawrence Tabak announced Aug. 2 that he has named Jeanne Marrazzo as director of the agency’s National Institute of Allergy and Infectious Diseases (NIAID).
While U.S. politics continues to delay Senate confirmation of the NIH director, other crucial positions at the agency that don’t require Senate action are being filled. Acting NIH Director Lawrence Tabak announced Aug. 2 that he has named Jeanne Marrazzo as director of the agency’s National Institute of Allergy and Infectious Diseases (NIAID).
The old adage of “what goes up must come down” rarely applies to U.S. FDA user fees. Most of the fiscal 2024 fees, which go into effect Oct. 1, continue in an upward slope. Under the PDUFA agreement, the fees for NDAs/BLAs are surging 25%. All but one of the MDUFA fees are going up 9.5%; the lone exception is growing by 18%. The MDUFA hikes are building on top of this year’s hefty increases. In the generics realm, the drug master file fee is going up 21%, but other fees increases are in the single digit range. Biosimilars, however, are the exception to the rule, with all the BsUFA fees seeing big drops.
The European Union and the U.S. have wrapped up a data privacy framework that covers broad swaths of both economies, including the transmission of clinical trial data across the Atlantic Ocean. Drug and device makers that want to make use of this framework and thus jettison the contractual clause to ensure data privacy may find compliance with this new framework much more efficient in the long run, but will have to do a lot of compliance work on the front end to achieve those efficiencies.
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