Potential legal barriers to increasing CMS/FDA collaboration: The law of trade secrets and related considerations

摘要

Sponsors of potentially beneficial medical technologies engage in two important processes to translate their discoveries into broadly employed drugs or devices Initially, they must secure approval or clearance by the Food and Drug Administration (FDA) to legally market their products Second, the sponsor must obtain coverage from third-party payers, the largest of which is Medicare, administered by the Centers for Medicare and Medicaid Services (CMS). In most cases these two processes occur sequentially, creating the potential for increased regulatory efficiency if FDA and CMS were to collaborate. Greater cooperation between FDA and CMS may enable them to process their respective applications simultaneously. Moreover, increased communication between the two agencies may prevent potentially conflicting regulatory decisions and increase the safety and clinical benefit derived from new healthcare technologies, Not surprisingly, the Department of Health and Human Services (DHHS) continues to seek means of making interaction between its agencies more efficient.