The free speech clause of the First Amendment is one of the many fundamental rights the framers of the Constitution believed were essential for all Americans. Much of the jurisprudence in the area of First Amendment rights began in the 20th century and continues today. Throughout the history of cases involving the free speech clause of the First Amendment, the Court was faced with interpreting what constituted speech and how to protect different types of speech. The Court has effectively and succinctly summed up its position on the free speech clause, “[i]f the First Amendment means anything, it means that regulating speech must be a last — not first — resort.” This statement is in line with the Court’s overall position that truth and free speech is essential for an open market place of ideas. One aspect of speech that the Court has ruled on is commercial speech, which has many different areas. Pharmaceutical marketing represents one of those areas and affects a large component of commercial speech. Such commercial speech has historically been afforded some protection by the courts under the free speech clause of the First Amendment. The Court has stated that the First Amendment “protects commercial speech from unwarranted governmental regulation...[and] [i]f the speech is lawful and not misleading, the State must assert a substantial interest to be achieved by restrictions on commercial speech.” This has paved the way for various cases in which state statutes impose content and speaker based restrictions dealing with various aspects of the sale, marketing, and product/information disclosure of pharmaceutical drugs. Such restrictions on speech are generally viewed with skepticism by the courts and are presumed to be invalid. In these instances the courts must balance the Government’s interest with the speakers First Amendment protections. A significant issue involving cases where a pharmaceutical regulation is claimed to have hindered a speakers First Amendment protection, is whether the statute actually affects speech. This begs the question, what is speech, more specifically commercial speech, within the context of the First Amendment? The courts have wrestled with that question in various cases dealing with commercial speech, specifically speech involving pharmaceutical marketing and statutes that impose content and speaker based restrictions. This analysis will delve into what is speech in the context of commercial speech in the form of pharmaceutical marketing, and how the courts have expanded this interpretation to off label marketing and pharmacy compounding. In addition, this analysis will discuss the roles that government agencies play in enforcing the court’s rulings and actions that must be taken to address the safety concerns of off label drugs use while weighing the various First Amendment issues. Additionally, this analysis will discuss how these pharmaceutical topics can pose a serious threat to consumer privacy and the solutions needed to address those concerns.