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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 …
The Monopoly Component Of Inflation In Food Prices, Neal Smith
The Monopoly Component Of Inflation In Food Prices, Neal Smith
University of Michigan Journal of Law Reform
Part I examines monopoly power in the food industry, paying close attention to the increased economic strength of monopolies and the economic costs caused by monopoly power. Part II details the problems resulting from monopoly power in one segment of the food industry-the meatpacking industry. Part III calls upon the Congress to undertake new antitrust initiatives to reverse the food industry's trend toward increasing concentration. It cannot be said with certainty that food price inflation would totally disappear if the consumer loss due to monopoly were removed from the food manufacturing and retailing sectors. Doing away with these losses, however, …