Yesterday, the United States Court of Appeals for the Second Circuit (based in NYC) made a 2-to-1 decision on United States v. Caronia (just one of many criminal cases pertaining to off-label use). This case even contained a supplemental briefing that had the litigants brief the applicability of Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011), to the Caronia case. In Sorrell, the Supreme Court ruled that a Vermont statute, which regulated certain speaker and content-based restrictions related to pharmaceutical companies was in violation the First Amendment of the U.S. Constitution.

The United States v. Caronia court decision threw out the conviction of conspiring to introduce misbranded drugs into interstate commerce, due to the allegedly inadequate directions for use on these particular pharmaceuticals. According to the Court, the representative's freedom of speech was violated due to the ban on off-label marketing. Caronia's freedom of speech was violated. The court ruled that, “we construe the FDCA [Federal Food, Drug, and Cosmetic Act of 1938] as not criminalizing the simple promotion of a drug’s off-label use because such a construction would raise First Amendment concerns.”

Other interesting aspects of the case include the following:

  • The presence of off-label promotion is a sufficient condition for the government to obtain a misbranding conviction, citing to the Government's proposed jury instructions in the Caronia case. But, off-label promotion of a pharmaceutical drug is not itself a crime.
  • Pharmaceutical manufacturers can disseminate discouraging safety warnings for a particular use, but they cannot implicitly promote the safety/efficacy of an off-label use to the product.
  • A pharmaceutical manufacturer may legally ship a drug that it knows will be used by a physician off-label.

The Court explained that FDA’s FD & C Act legalizes the outcome of off-label use by doctors, despite the thought that it "prohibits the free flow of information that would inform that outcome.” The Court further explains “the misbranding provisions of the FDCA as not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs.” Additionally. the ruling claims that “the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.”

But, can the government prosecute medical device manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved device? Are combination products included?

This is an incredible ruling, which has the potential to shake up the healthcare industry in a big way. The outcome of United States v. Caronia could mean major changes and a large impact to FDA and the companies whose products FDA regulates. But, before we get too excited about the Court's ruling, we need to remember that the United States v. Caronia ruling applies only within the Second Circuit of NYC. Despite this, we may still find ourselves seeing more changes to marketing policies. If marketing policies do begin to drastically change, what will this mean for pharmaceuticals and medical devices in terms of off-label promotion? Will the outcome of United States v. Caronia positively or negatively impact the industry?

Please, leave your thoughts and comments about this recent ruling!

 

-RSpelich ^_^

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