Abuse of U.S. generic-drug rules costs billions: report

By Diane Bartz WASHINGTON (Reuters) – U.S. rules that ensure prescription medicines are not misused have been manipulated by brand-name drug companies to fight off generic competitors, costing consumers billions of dollars, according to a report released on Wednesday. Called “risk evaluation and mitigation strategies” (REMS), these U.S. Food and Drug Administration rules are meant to secure the safe distribution of dangerous medicines. This has delayed the arrival of 40 potential generic drugs, costing consumers some $5.4 billion a year, according to the report by Matrix Global Advisors and released by the generic drug trade group.