Earlier this month, FDA issued a final guidance titled “Medical Product Communications that are Consistent with the FDA-Required Labeling – Questions and Answers.” This Final Guidance follows the draft guidance document issued in January 2017 and sets forth FDA’s further position with respect to manufacturer communications consistent with FDA-required labeling.
- Application. The Final Guidance appliesto labeling and advertising, referring tothose communications over which FDA has statutory regulatory authority and other product communications that present information not contained in the FDA-required labeling for the product but that may be consistent with FDA-required labeling for the product.
- Scope. The Final Guidance does not apply to 510(k) and 510(k)-exempt devices. FDA advises manufacturers of those products to continue to assess communications pursuant to 21 C.F.R. §807.81(a)(3) and FDA’s guidance “Deciding When to Submit a 510(k) for a Change to an Existing Device.” For 510(k)-exempt devices, firms should analyze communications in accordance with the limitations of exemptions applicable to their device.
- Intended Use. FDA reaffirms that required labeling “is not intended to exhaustively address all that is known about a product for its approved or cleared uses.” When a firm communicates information that is consistent with the FDA-required labeling, FDA does not intend to rely on that communication to establish a new intended use different from the use(s) for which the product is legally marketed. As always, however, FDA will consider communications in their totality. If a portion of the communication is consistent with the FDA-required labeling, that does not mean another portion could not be viewed as establishing a new intended use. Firms need to continue to apply robust review processes to these types of communications — whether promotional or not — with input from a committee including legal, medical and regulatory representatives.
- Three-factor Test. To determine whether a communication is consistent with FDA-required labeling and is truthful and non-misleading, the Final Guidance sets out the three-factor test for firms to apply:
- Are the conditions of use described in the communication consistent with the product labeling?
- Does the communication alter the risk-benefit profile of the product in a way that may result in increased harm to health?
- Does the product labeling enable the product to be used safely and effectively for the conditions of use described in the communication?
FDA provides examples of how the three factors may be used by manufacturers to assess whether a communication is consistent with FDA-required labeling.
- Communications Consistent/Not Consistent With FDA-required Labeling. FDA notes that the determination of whether a communication is consistent with the FDA-required labeling must be made separate from any evaluation of the communication under other labeling and advertising provisions. The Final Guidance includes examples of communications that are and are not consistent with the FDA-required labeling. FDA also reaffirms that consistency with the FDA-required labeling does not preclude a communication from being false, misleading or inappropriate for other reasons.
- Scientifically Appropriate and Statistically Sound. In order to determine whether a communication is truthful and non-misleading, the fundamentals of substantiation practices still apply. Communications must be grounded in facts and science, make material disclosures, be presented with appropriate context (including related data from the FDA-required labeling), and rely upon scientifically appropriate and statistically sound analyses. Specifically, FDA states that information based on “speculation or belief,” as well as information “based on a poorly designed or conducted study or analysis,” would not meet the substantiation standard, but it does not elaborate on data sources that may be inappropriate. In general, the Final Guidance explains that the standard is a flexible one, stating that “FDA believes that a variety of types and studies and analyses can provide useful additional information about a medical product for its approved/cleared conditions of use” so long as “firms’ product communications [do] not overstate the findings of or the conclusions that can be drawn from such studies or analyses, or fail to disclose their material limitations.”
- Substantial Evidence. The Final Guidance acknowledges that “evidence other than that which meets the new drug approval standards of ‘substantial evidence’ of effectiveness could be used to support certain representations or suggestions about a prescription drug in a CFL (consistent with FDA-required labeling) promotional communication.” This appears to be an acknowledgement by FDA of the fact that 21 C.F.R. §202.1(e)(6) requires that prescription drug advertising claims be supported by substantial evidence. What this may indicate is that FDA may exercise enforcement discretion where product communications comport with the Final Guidance.
The Final Guidance provides further insights into FDA’s latest thinking about truthful, non-misleading product information, and gives additional flexibility to manufacturers as they develop these materials.