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
A 2010 research study found that treating two patients per bottle instead of one would decrease plastic waste by approximately 12.69 The product manufacturers and vendors will need to be active partners as well. Eye 24 , 361–363 (2010). tons in the United Kingdom each year. hospital upwards of $240,000 over 5 years. 3 “Each U.S.
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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.
My Green Doctor
MAY 3, 2025
A 2010 research study found that treating two patients per bottle instead of one would decrease plastic waste by approximately 12.69 The product manufacturers and vendors will need to be active partners as well. Eye 24 , 361–363 (2010). tons in the United Kingdom each year. hospital upwards of $240,000 over 5 years. 3 “Each U.S.
FDA Law Blog
APRIL 16, 2024
Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).
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.
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