Open Access. Powered by Scholars. Published by Universities.®
Articles 1 - 2 of 2
Full-Text Articles in Entire DC Network
Exasperated But Not Exhausted: Unlocking The Trap Set By The Exhaustion Doctrine On The Fda’S Rems Petitioners, Michael Krupka
Exasperated But Not Exhausted: Unlocking The Trap Set By The Exhaustion Doctrine On The Fda’S Rems Petitioners, Michael Krupka
Vanderbilt Law Review
When health is at stake, bureaucratic delays can be disastrous. This is especially true in the field of pharmaceutical regulation. Fortunately, concerned parties—ranging from research institutions and universities to doctors and pharmaceutical companies—can file citizen petitions to urge the Food and Drug Administration (“FDA”) to regulate potentially risky drugs through Risk Evaluation and Mitigation Strategies (“REMS”) programs. But despite submitting comprehensive citizen petitions calling for changes to REMS determinations, petitioners regularly await the FDA’s response for years. When these petitioners, still awaiting an FDA determination, have sought recourse in the courts, the agency has argued that these petitioners have not …
Reducing Diet-Induced Cancer Through Federal Regulation: Opportunities And Obstacles, Richard A. Merrill
Reducing Diet-Induced Cancer Through Federal Regulation: Opportunities And Obstacles, Richard A. Merrill
Vanderbilt Law Review
For more than a decade, federal health regulatory agencies have devoted major attention to controlling human exposure to substances believed capable of causing cancer. These efforts have evoked a broad spectrum of criticism; government has been accused of both indolence in the face of an incipient epidemic' and reckless distortion of science to support restrictions on substances that present only trivial risks. A central object of regulatory concern has been the safety of the food supply. At least since the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act),'with its famous Delaney Clause, the Food …