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Full-Text Articles in Law
Seeing Through The Murky Vial: Does The Fda Have The Authority To Stop Compounding Pharmacies From Pirate Manufacturing?, Michael Snow
Seeing Through The Murky Vial: Does The Fda Have The Authority To Stop Compounding Pharmacies From Pirate Manufacturing?, Michael Snow
Vanderbilt Law Review
In late 2012 and early 2013, tainted steroid shots from the New England Compounding Center ("NECC") caused fifty-five deaths and 745 cases of fungal meningitis in twenty states.' On October 1, 2012, the Food and Drug Administration ("FDA") inspected NECC and found vials of steroids filled with enough floating contamination to be visible to the human eye. These NECC steroid shots were distributed primarily to treat back pain, but the patients who received them were injected with foreign matter containing the deadly fungi Exserohilum rostratum or Aspergillus fumigatus. The earliest reported death from fungal meningitis caused by NECC was seventy-eight-year-old …
Pay-To-Delay Settlements: The Circuit-Splitting Headache Plaguing Big Pharma, Shannon U. Han
Pay-To-Delay Settlements: The Circuit-Splitting Headache Plaguing Big Pharma, Shannon U. Han
Vanderbilt Journal of Entertainment & Technology Law
At its passage, the Hatch-Waxman Act was hailed as a much-needed step in making generic drugs more readily available to consumers, easing some of the heavy burdens placed on consumers by the necessary, but flawed, patent system that essentially granted brand-name pharmaceutical manufacturers a de facto economic monopoly over their drugs. One consequence of the Act, unforeseen by legislators and regulators, was the creation of a perverse incentive on behalf of pharmaceutical patent holders to pay alleged patent infringers substantial cash payments to delay entry into the particular drug market. These pay-to-delay settlements--or reverse-payment settlements--have been at the center of …
Preemption Under The Controlled Substances Act, Robert A. Mikos
Preemption Under The Controlled Substances Act, Robert A. Mikos
Vanderbilt Law School Faculty Publications
States are conducting increasingly bold experiments with their marijuana laws, but questions linger over their authority to deviate from the federal Controlled Substances Act. The CSA bans marijuana outright, and commentators have assumed that Congress sought to preempt all state laws that might somehow conflict with the CSA. Under the preemption rule now in vogue, state marijuana reforms are preempted if they either require someone to violate the CSA or, more controversially, if they pose an obstacle to Congress’s objective of eradicating marijuana. Seeking to avoid such conflicts, government officials have scuttled a number of important state marijuana reforms. This …