jueves, 25 de febrero de 2016

USA: "Policy Options for Off-Label Communication." / Duke-Margolis Center for Health Policy

The regulation of methods for communicating about off-label use of medical products approved by the U.S. Food and Drug Administration (FDA) has long been a challenging area of policymaking. 

On the one hand, new steps to facilitate the development and dissemination of accurate information about off-label uses of medical products could lead to a better understanding of the relevant evidence by providers, patients, payers, and others who make or influence treatment decisions. This could lead to better decisions for many patients: estimates suggest that around 40% of overall prescribing decisions are off-label, as are most decisions in some critical areas like cancer care.1 By some accounts, these rates appear to be rising. 

On the other hand, such policy changes could lead to more instances of evidence being taken out of context or used inappropriately without being submitted to FDA for rigorous independent regulatory review, leading to harm or added costs for patients and potentially undermining the incentives for developing evidence that is good enough to be placed in approved drug labeling. (Más)

Para  PharmaGuy... 

Drug "wonks" (e.g., Peter Pitts et al) at the Duke-Margolis Center for Health Policy released a report on "Policy Options for Off-Label Communication." 

The report authors want to end the off-label drug promotion (or, as they call it, "communications") "chaos" by creating an FDA-sanctioned "clearing house" or third-party organization that would accredit ("rank, score, or grade") off-label drug communications. (Más)

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