The US Food and Drug Administration (“FDA” or “agency”) issued a draft guidance for Industry last week, entitled Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products – Recommended Practices.
The guidance represents the agency’s current thinking on recommended practices for drug manufacturers and their representatives to follow if they choose to distribute to healthcare professionals or healthcare entities scientific or medical journal articles that discuss new risk information for approved prescription drugs marketed in the US.
Specifically, the guidance addresses issues specific to the distribution of new information about risks associated with a drug that further characterizes risks identified in the approved labeling.
The guidance does not apply to newly identified risks or new information that indicates that a risk already identified in approved labeling is more serious than currently reflected in that labeling.
In the guidance, the agency explains that companies can pass along new clinical trial findings that make their products appear safer, but the companies must vet and distribute the research properly because, if the new information is unreliable or presented without the appropriate context, it could influence prescribing decisions or patient monitoring in a way that can be harmful to patients.
Additionally, the study design must have a clear hypothesis and an accounting of potential structural bias and must be at least as persuasive as the earlier research that indicated certain risks; should give suitable weight to contrary findings; and should be published in an independent, peer-reviewed journal. When disseminating reprints, companies must include a cover page that clearly and prominently describes the study design, critical findings, significant limitations, the divergence from approved labeling, any financial interests between the drug manufacturer and the study authors, and must indicate that the FDA has not reviewed the study.
The agency also noted its expectation that the approved labeling will accompany the reprints and will not be distributed with promotional materials. The agency also stated its intent that discussion of the reprints will be consistent with these above-stated cover letter requirements. In the guidance, the agency explained that failure to comply with these conditions could render a drug’s labeling false or misleading, which could constitute misbranding and result in harsh penalties.