In an announcement dated September 14, 2023, the Federal Trade Commission (FTC) issued a policy statement warning pharmaceutical companies against improper listings of patents in the FDA’s Orange Book. This is a remarkable move in the commission’s push to bolster generic competition and comes amid an era of rising scrutiny on practices perceived to thwart market competition.
The Orange Book, officially titled Approved Drug Products with Therapeutic Equivalence Evaluations, is used by healthcare professionals and others to find FDA-approved drugs. It also provides data about each listed drug, including patent information. The fair and correct listing of patents in the Orange Book is therefore crucial for maintaining market integrity.
This new policy from the FTC builds on the premise that brand drug manufacturers may be jeopardizing generic competition through the incorrect listing of patents in the Orange Book. Specifically, the FTC suggests that this practice is harmful and could lead to legal battles for those found guilty of such offenses.
The statement is also a clear indication of the FTC’s intent to use its full legal powers to fight manipulative practices that could hamper the pharmaceutical marketplace’s effective operation. The FTC’s message is unequivocal. It will nbot hesitate to take action against companies found guilty of such improper behavior.
The exact impact that this policy will have on the industry has yet to be seen and will likely depend on the intensity of the FTC’s enforcement in practice. Nevertheless, pharmaceutical companies should be proactive in complying with this new policy, thereby preventing any unforeseen repercussions.