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Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang
Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang
University of Michigan Journal of Law Reform
Off-label promotion occurs when pharmaceutical manufacturers engage in promotion of unapproved or "off-label" uses of their drugs. These off label uses may lack adequate clinical data to substantiate marketing claims, have led to corporate investigations and penalties, and can endanger public health. However there is adequate evidence to suggest that off-label uses are entirely appropriate for some vulnerable patient populations, and that physicians have accepted such uses as standard. Historically, U.S. law has prohibited direct off-label promotion to physicians and patients. However, failed government guidance, industry-based litigation, and the diminished capacity of regulators to police illegal practices have had dire …
Did The Fda Properly Assess The Safety Of Olestra As A Food Additive?, Leah Lebel
Did The Fda Properly Assess The Safety Of Olestra As A Food Additive?, Leah Lebel
The Science Journal of the Lander College of Arts and Sciences
The following is an excerpt of the introduction to this article: Olestra, a fat-substitute comprised of sucrose that has been esterified with fatty acids (Blume 1995), has been the subject of much controversy ever since its creation. Olestra is not absorbed (Mattson and Nolen 1972) because it cannot be hydrolyzed by pancreatic lipases (Mattson and Volpenhein 1972) or taken up across the enterocyte microvillus membrane (Freston et al. 1997), and thus, cannot be utilized for energy. Olestra has physical and organoleptic properties similar to those of traditional triglycerides (Jandacek and Webb 1978) and is emulsified together with triglyceride (Freston et …