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Access Before Evidence And The Price Of The Fda’S New Drug Authorities, Erika Lietzan
Access Before Evidence And The Price Of The Fda’S New Drug Authorities, Erika Lietzan
University of Richmond Law Review
Sometimes drug innovation seems to happen in reverse. Patients enjoy a treatment for years even though the treatment has not been approved by the FDA or proven safe and effective to the FDA’s standards. (Sometimes this happens because the FDA has declined to take enforcement action.) The agency encourages companies to perform the work necessary to satisfy the United States “gold standard” for new drug approval, however, by promising exclusivity in the marketplace. When a company does this work, at considerable expense, the results are predictable. The new drug is expensive, and patients and payers (and sometimes policymakers) are outraged. …
On Opioids And Erisa: The Urgent Case For A Federal Ban On Discretionary Clauses, Katherine T. Vukadin
On Opioids And Erisa: The Urgent Case For A Federal Ban On Discretionary Clauses, Katherine T. Vukadin
University of Richmond Law Review
The American opioid epidemic cuts across all social divisions, touching the employed and unemployed. Those with private health insurance are one of the fastest-growing affected groups, but this group struggles most to get care. Despite their insured status, the privately-insured received treatment at half the rate of those with Medicaid and at even lower rates than the uninsured. This article focuses on a significant barrier to treatment for those in employer sponsored benefit plans: the discretionary clause. A discretionary clause grants the decision maker broad latitude and ensures that any federal court review is deferential. Claims processing in such a …