Lexology January 5, 2024
With the J.P. Morgan Healthcare Conference taking place in San Francisco this week, what better time for an update on the Orange Book? The US Federal Trade Commission (FTC), supported by the US Food and Drug Administration (FDA), recently issued a policy statement describing how the FTC intends to “scrutinize improper Orange Book listings” to identify potential violations of Section 5 of the FTC Act, which prohibits “unfair methods of competition.”
There were many unanswered questions when the policy statement was issued in September 2023—and at the time of our first blog post on this subject—including what types of listings the FTC would consider “improper” and what actions it would actually take to enforce this policy statement. Recent warning letters...
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