FDA, CMS To Begin Collaborating On Drug Safety Data Collection In 2005
This article was originally published in The Pink Sheet Daily
Executive Summary
HHS Medical Innovation Task Force report says CMS will assist FDA in postmarketing drug surveillance. The collaboration also includes parallel reviews by the two agencies to minimize delays between marketing approval and reimbursement.
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FDA will begin using drug safety information collected by the Centers for Medicare & Medicaid Services in 2005. "FDA and CMS will initiate several pilot projects this year to collect safety information on approved medical products," a 1 report by HHS' Medical Innovation Task Force states. The Jan. 13 report, "Moving Medical Innovations Forward - New Initiatives from HHS," recommends undertaking five initiatives, including collaboration between FDA and CMS. The report notes that FDA's use of CMS data for postmarket surveillance activities "is limited." "Greater use of existing information and mechanisms (consistent with the Health Insurance Portability & Accountability Act privacy rule), and the collection of new data through implementation of the [Medicare] Part D prescription drug benefit...could provide FDA, CMS, industry, and, ultimately, the public, with invaluable information regarding the use of medical products," the report says. The report notes that "FDA and CMS have agreed to collaborate" in several areas. A recent memorandum of understanding between the two agencies included data sharing for parallel product reviews and post-marketing surveillance (2 (Also see "FDA/CMS Formal Collaboration Will Include Data Sharing, Parallel Review" - Pink Sheet, 11 Jun, 2004.)). Parallel review is an element of FDA/CMS collaboration discussed in the task force report. "At the request of an applicant, and with the concurrence of both agencies, FDA regulatory review and CMS review would be conducted in parallel to minimize delays between marketing approval and reimbursement," the report explains. FDA also will expedite the redaction of a new product's Summary of Safety and Effectiveness upon CMS' request in order to speed up coverage determinations. The task force also recommended that FDA and the National Institutes of Health collaborate on an initiative to standardize electronic data capture and management for clinical trials. "This collaboration will identify the gaps in the existing standards between current methods and more advanced electronic data systems. We expect to make rapid progress over the next two years to develop usable standards for this initiative," the report says. FDA's Center for Biologics Evaluation & Research recently announced a pilot to improve the use of electronic datasets from BLA sponsors (3 (Also see "CBER Pilot Seeks To Improve Use Of Electronic Datasets" - Pink Sheet, 29 Dec, 2004.)). Another initiative will be cross-training HHS technology transfer office personnel to help them better understand the FDA approval process, intellectual property issues and "how to collaborate among public and private sector entities to move innovations along the development pipeline." Other task force recommendations are establishing MOUs between HHS and other federal departments with an interest in medical technology and streamlining HHS involvement in medical technology using the Interagency Council on Biomedical Imaging in Oncology as a model. HHS created the task force in May. The group held a public meeting on medical innovation in November (4 (Also see "PhRMA Seeks Regulatory Guidance On Primary Prevention Products" - Pink Sheet, 8 Nov, 2004.)). - Scott Steinke |