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Full-Text Articles in Medical Jurisprudence
Section 1115 Waivers: Innovation Through Experimentation, Or Stagnation Through Routine?, Nicole Johnson
Section 1115 Waivers: Innovation Through Experimentation, Or Stagnation Through Routine?, Nicole Johnson
Emory Law Journal
The Medicaid program operates as a federal-state partnership, in which the states agree to meet certain federally mandated requirements in exchange for federal matching funds for program expenditures. These federal matching funds can be anywhere from 50–90% of health care expenses incurred through state Medicaid programs. As such, states have a substantial interest in continuing this partnership and ensuring that their state plans comply with federal requirements. There is a way, though, in which states can gain more freedom in building their individual state plans. Through section 1115 waivers, states can ask the Centers for Medicare and Medicaid Services (“CMS”) …
Off-Label Speech, David A. Simon
Off-Label Speech, David A. Simon
Emory Law Journal
This Article argues that the Food and Drug Administration (“FDA”) should regulate drug manufacturer speech about off-label uses based on the evidentiary support for the relevant use. The more evidence that an off-label use is safe and effective, the less restrictive the regulation should be. The less evidence that an off-label use is safe and effective, the more restrictive the regulation should be. Although intuitive, this is not exactly how current regulation of off-label information works. If the FDA approves a drug, the manufacturer can advertise to doctors and patients for the approved indication. Drug manufacturers cannot, however, promote or …