PhRMA Sues To Block HHS Drug Importation Rule Citing Security, Safety, First Amendment Concerns
Complaint lists host of problems with implementation of the rule that allows states to sponsor programs to import certain prescription drugs from Canada; at least six states have enacted legislation to sponsor these programs.
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A surprise move to unwind FDA’s efforts to end the marketing of unapproved drugs is in keeping with the overall sense of the top-down intervention in the agency’s policies at the end of the Trump Administration. It is also an unfortunate consequence of the embrace of drug pricing as part of FDA’s mission.
A Biden Administration with near-term priorities other than drug pricing and a Republican-controlled Senate dedicated to blocking any legislation that would enact government price controls is a relatively positive outcome for industry.