Why REMS Abuse Doesn't Belong In Antitrust Litigation

Law360, New York ( April 23, 2015, 4:30 PM EDT) -- When asked to identify the "next generation" of antitrust claims in the pharmaceutical industry, many practitioners, industry publications and conference organizers would respond with an acronym: REMS. Indeed, in recent years there has been a small crop of complaints alleging that brand pharmaceutical companies take advantage of various U.S. Food and Drug Administration-imposed "risk evaluation and mitigation strategy" — or REMS — restrictions to delay or block generic competition. The Federal Trade Commission has shown interest in this area as well. Conventional wisdom is that actions alleging abuse of REMS, alongside actions involving biologics and biosimilars, will follow the wave of reverse payment antitrust litigation currently occupying the FTC and so many courts....

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