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Our clinical pharmacists and and former Federal Circuit Clerks take you through the basics of skinny labels and off-label drug use. 

 

Topics included in this episode:

  • Definition and motivations behind skinny labels

  • Examples of skinny labels in the market

  • Small molecule drugs vs. biosimilars

  • Payer, provider, manufacturer, retailer, and patient implications

  • Off-label use regulation

 

IPD'S DRUG & CLINICAL REVIEW:

SKINNY LABELS & OFF-LABEL UTILIZATION

"So, I guess really what we're talking about here is how comfortable a prescriber is with off-label use. Are there regulations that control off-label use in either biologics or small molecule drugs?

 

Well, the regulations and guidance surrounding off-label use really varies by who we're talking about in terms of stakeholders. First, it's important to note that labeled indications do not necessarily align with clinical evidence or common practice. Some off-label use is well established with a lot of clinical evidence. This often occurs when a new use for a drug is revealed, when the drug is nearing its loss of exclusivity date, or has been on the market as a generic for several years. At that time, it wouldn't be supported by a brand manufacturer to fund new studies or submit them to the FDA for the new indication. Other products, however, may have limited evidentiary support for off-label use. In terms of stakeholders, for prescribers, other than the potential liability associated with an adverse outcome due to a drug used off-label, there's really not a great deal of restriction for prescribers when it comes to use of drugs or biologics off-label. In fact, we see it all the time. Using a dose or frequency that's not in the FDA-approved label, prescribing for a different population such as adolescents (if the product is only labeled for adult use), or as we just discussed using a product for a completely different indication altogether. We also see examples where the same molecule may be sold under different brand names, each with a different labeled indication. If a generic for one of them were to launch and its low cost, we often see a shift away from the brand competitor regardless of the label."