FDA Law Blog
MAY 30, 2024
Kirschenbaum — Last week, the United States Court of Appeals for the District of Columbia ruled that Section 340B of the Public Health Service Act does not prohibit pharmaceutical manufacturers from imposing conditions on the distribution of discounted drugs to covered entities in the program. In United Therapeutics Corporation v.
My Green Doctor
MAY 3, 2025
Innovative surgeries, novel pharmaceuticals, and state of the art technology are just a few of the driving forces that have aided the delivery of exceptional care to patients across all specialties. Dilating and anesthetic eye drops are used routinely to treat patients in most ophthalmology clinics. 3 “Each U.S.
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My Green Doctor
MAY 3, 2025
This isn’t just about saving the planet—it’s also about saving money, protecting patients, and strengthening our healthcare systems from the inside out. Dilating and anesthetic eye drops are routinely offered to patients in most ophthalmology clinics. Now, more than ever, they must also become champions of planetary health.
FDA Law Blog
NOVEMBER 1, 2023
Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.
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. Code Ann.§
FDA Law Blog
NOVEMBER 7, 2021
We reported that HRSA was proceeding with enforcement actions against drug manufacturers that have declined to sell to 340B covered entities that use multiple contract pharmacies to dispense 340B drugs to their patients, despite the pendency of several lawsuits challenging such enforcement. Last week, the U.S.
FDA Law Blog
SEPTEMBER 29, 2021
The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.
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