FDA Law Blog
AUGUST 12, 2021
Though Congress enacted the pathway for approval of interchangeable biosimilars in 2010 in an effort to incentivize competition to address the high prices of biologics, no sponsor had yet to crack the code to interchangeable approval until now. The expectation is that interchangeable biologics would make all the difference.
FDA Law Blog
OCTOBER 6, 2021
By Faraz Siddiqui — Last week, we blogged about a growing list of drug manufacturers that have refused to follow a 2010 guidance issued by the Health Resources and Services Administration (“HRSA”), which permits 340B covered entities to contract with multiple pharmacies to dispense drugs to covered entity patients.
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FDA Law Blog
FEBRUARY 9, 2022
27, 2010). In Gulf Med , DEA emphasized that “[r]ed flags are circumstances surrounding a prescription that cause a pharmacist to take pause, including signs of diversion or the potential for patient harm.” Cash payment for controlled prescriptions rather than payment by insurance (or worker’s compensation) is another red flag.
FDA Law Blog
OCTOBER 28, 2021
In some instances, however, this is only the first hurdle to make innovative products available to patients. The imposition of insurance-related hurdles beyond FDA approval, such as time-consuming prior authorizations or costly co-payments, can impede access to critical health care, such as contraceptives. 300gg-13(a)(4).
GeriPal
JUNE 22, 2023
Healthcare staff were afraid of patients with HIV because there wasn’t clarity on how it was transmitted. So in 2010, there were about 150,000 incarcerated people in California. But when we look at people over the age of 55, 55 and older, we had about 11,000 in 2010, and now we have 18,000 people aged 55 and older.
GeriPal
JUNE 5, 2025
Eric 03:25 So we have a lot to talk about, but I’m wondering if we can kind of take a big step back and just talk about the patient population that’s in nursing homes. Connie 06:18 So, I’ve been a clinician working in the nursing home since back in the 80s, and I saw a lot of patients that really needed palliative care.
Physician's Weekly
JUNE 17, 2025
But that’s when his family began fighting another adversary: their health insurer, which decided the treatment was “not medically necessary,” according to insurance paperwork. Health insurers issue millions of denials every year. For most patients, though, the process works seamlessly. Senate report.
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