The Federal Trade Commission (FTC), with the endorsement of the Food and Drug Administration (FDA), recently took a significant action that reflects their collective intent to aggressively police the pharmaceutical industry. On September 14, the FTC announced its intent to “scrutinize improper Orange Book listings” as part of its strategy to identify possible infringements of Section 5 of the FTC Act. This act, among other regulations, prohibits unfair methods of competition.
The details of this announcement were elaborated by Morgan Lewis, a renowned law firm. Through this move, the FTC has planted a new flag on relatively unfamiliar grounds, since the FDA’s Orange Book, a catalogue of approved drugs established under the Drug Price Competition and Patent Term Restoration Act (commonly known as the Hatch-Waxman Act), is principally regulated by the FDA.
This development could potentially reshape the dynamics of the pharmaceutical industry, particularly in the context of generic drug competition. It also underscores the intent of the FTC to focus on the pharmaceutical industry as a key area of operation. The FTC’s engagement in traditionally FDA-regulated areas shows an aggressive new initiative in focusing on patent-related issues in the pharmaceutical industry.
Legal professionals, particularly those working in the pharmaceutical industry, should monitor these ongoing developments closely, as their implications may dictate upcoming FTC-FDA cooperative enforcement strategies. A proactive understanding of these advancements can help entities adapt their compliance measures accordingly.