Second Circuit Okays Off-Label Promotion: What Will Be the Impact on Provider/Rep Interaction?

Sydney Abbott, JD
Policy Coordinator, Association of Community Cancer Centers

Since 2004, under the False Claims Act, whistleblowers have fueled numerous federal investigations into fraudulent claims for reimbursement from federal programs, such as Medicare, that violated the Food, Drug, & Cosmetic (FD&C) Act. But now the long-held understanding that a pharmaceutical representative may not discuss any off-label use of a US Food and Drug Administration (FDA)-approved drug with a provider has been turned on its head by a federal appellate court in Manhattan.

The controversial decision to allow pharmaceutical sales representatives to promote drugs for off-label use was recently determined in a 2-1 decision by a 3-judge panel in the Court of Appeals for the Second Circuit, in United States v. Caronia. However, because of the Second Circuit’s jurisdiction, this ruling is only applicable for New York, Connecticut, and Vermont.

Protecting Consumers

Everyone knows that the First Amendment protects free speech in most situations. However, to protect consumers—in this case, providers and patients—commercial speech is more closely regulated. To regulate commercial speech, the government would have to pass a series of questions:

  1. Is the speech false or misleading?
  2. Does the restriction support a substantial government interest?
  3. Does the restriction directly advance that interest?
  4. Is the restriction narrowly tailored to serve that purpose?

In the case of off-label promotion of FDA-approved medications, the Court determined that:

  1. Promoting a medication for off-label uses, when supported by compendia, is not misleading, but
  2. Protection of patients is a substantial government interest, but that
  3. The regulation of off-label promotion does not necessarily protect patients, therefore
  4. Regulation of off-label promotion where the promotion is supported by recognized compendia is not appropriate.

Most likely, this ruling will not impact the conversations pharmaceutical representatives have with providers immediately. However, there are certain things that cancer care providers should know about this important decision.

This ruling is a complete reversal of the way the FDA views the issue. The government justifies its crackdown on off-label promotion on the grounds that it is protecting the integrity of the FDA’s drug approval process. The FDA wants to discourage manufacturers from seeking approval for only a narrow—and easily approvable—claim while intending to actually promote the drug for much wider uses. However, providers need not fear that pharmaceutical representatives will soon start to promote drugs recklessly, primarily because of other potential state and federal litigation that drug manufacturers could face, not to mention the harm it could do to the manufacturer’s reputation.

The FDA has stated that it will not appeal the Second Circuit’s decision to the Supreme Court of the United States. The FDA feels that because the decision is limited to just a few states and because the ruling does not strike the provision of the FD&C Act or impact any misbranding provisions, further advancement of this case is not necessary. While the decision determines that some off-label promotion is permitted, the Court’s analysis still leaves questions, such as the scope of off-label promotion. Is it limited to drugs only, or can it extend to anything else the FDA has its hand in, such as medical devices, tobacco, or even diet aids? The Court also did not define what constitutes false or misleading speech, or address the impact this could have on civil suits for off label promotion.

The primary takeaway for cancer care providers is to know that most likely nothing will change in your interaction with pharmaceutical representatives in the near term. In every state besides New York, Connecticut, or Vermont, any discussion of off-label uses by drug representatives is still prohibited by law. Certainly as this policy evolves, ACCC will keep its members informed of its implications for cancer care providers.

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