Off-Label Promotion by Manufacturers: FDA Modifies Rules for Enforcement
(Thursday, September 24, 2020]
FDA enforcement officials would have to reach a higher standard of evidence for accusing a manufacturer for off-label promotion. This week FDA released a new rule describing a wholistic approach to assess the intent of a manufacturer to promote new uses of a previous-approved product thereby creating flexibility in enforcement of marketing practices unlike any before. FDA approval of a product is based on the evidence presented to it in market approval applications. At the time of approval, FDA permits only claims supported by the information it has reviewed. Manufacturers are expected to strictly follow the FDA approved label. However, post-approval, new uses of the product may become evident during clinical practice and other sources. Manufacturers benefit financially from such new uses as it directly increases the sales of their product beyond the market defined by the FDA approved label. There is no law restricting off-label prescription by doctors and use by consumers. However, to promote such new uses, manufacturers are required to present information supportive of the new uses to the FDA for formal review and amendment of their approved label, a process that takes time and expense, and delays the financial windfall of the off-label use, hence creating an incentive for the manufacturers to promote off-label uses without or prior to formal FDA approval of those uses. In the past, FDA has aggressively persecuted off-label promotion, and fined the violators hefty fines, a few times hundreds of millions to a few billions of dollars. Under the new rules, many of those activities would no longer be considered punishable. Manufactures will be held liable if they explicitly or implicitly promote or sell products for off-label uses, or manufacture adulterated products mixing approved and unapproved products, but will not be penalized for selling to customers who they know to use the product off-label under the new “safe harbor” provision, providing safety information supportive of off-label use to prescribers, subliminally support off-label uses on social media, making public submissions to SEC about their off-label sales, or creating special clinical trial summaries for the participants in their clinical trials which, in turn, may get distributed beyond the original recipients. Several of the exclusion from penalty conditions described in the new rules have led to Warning Letters and punitive actions in the past. The new rules leaves the option to the FDA enforcement officials to looks at the wholistic picture of the off-label uses where individual activities that are permitted may be suspicious in the context of other activities but the increased burden of evidence needed to prosecute will assure that only the most egregious violators would be prosecuted, while most companies will comfortably live with the flexibilities created for them. This new rule which will be critiqued by the FDA hardliners, will be welcomed by the industry for its pro-industry intent. The rule that will become effective on the 23rd of October.