Ryan Sila


Incentivizing Pharmaceutical Testing in an Age of Off-Label Promotion

Ryan Sila

In 2012, the Second Circuit held that under the First Amendment, pharmaceutical manufacturers have a right to promote their drugs for uses for which that they have neither been clinically tested nor FDA-approved. Weighing heavily in the Second Circuit’s analysis was the argument that the FDA’s prohibition on so-called “off-label speech” inhibited physicians’ access to complete information, thereby harming public health. That line of reasoning has also created skepticism within Congress of the FDA’s policy. Others argue that the prohibition on off-label speech is necessary in order to incentivize manufacturers to clinically test their drugs for all intended uses—a process that not only allows the FDA to certify the drug as safe and effective in each of its uses, but also creates a larger data set about a drug’s effects before it begins to be marketed and prescribed. If manufacturers can market their pharmaceutical products for unapproved uses, they have reduced incentives to seek FDA approval, especially because the required clinical tests are extremely costly. Whatever one believes about a policy of permitting off-label promotion, it is clear that it not only creates benefits, but it also creates costs. This Note considers regulatory and common-law tools to reduce those costs. It rejects available regulatory tools, because either they are too weak to change manufacturers’ incentives to conduct clinical tests, or they suffer from the same constitutional questions that troubled the Second Circuit. Instead, this Note argues that courts can hold manufacturers to a common-law duty to test their drugs for each use for which they market them, and it outlines what such a duty might entail. Such a solution, if properly implemented, would not only mitigate the concerns about the liberalization of off-label promotion, but it would also be supported by modern products liability doctrine.