FDA's Science Board To Review Comparative Effectiveness, Pharmacovigilance, Nanotech
This article was originally published in The Pink Sheet Daily
Executive Summary
The May 20 meeting follows a recent reorganization of the safety functions in the Center for Drug Evaluation and Research.
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Not long after FDA announced the founding of a new Office of Pharmacovigilance and Epidemiology, the agency has announced that the May 20 meeting of its Science Board Advisory Committee would include a discussion of the agency's efforts on pharmacovigilance. The creation of the new office is part of a broader administrative reshuffle at the Center for Drug Evaluation and Research (Also see "CDER Reorganization Creates Drug Safety “Super-Office”; Management Support Is Goal" - Pink Sheet, 4 Apr, 2011.). The existing epidemiology and pharmacovigilance divisions are being folded into OPE, which also will include a newly created Division of Epidemiology II. Perhaps the highest profile pharmacovigilance program the agency has running is the Sentinel Initiative, which was mandated under user fee legislation and is intended to improve post-marketing safety through a national, integrated electronic system for monitoring drugs and medical devices (Also see "FDA’s Sentinel Program Readies For Patrol As Stakeholders Watch For Details" - Pink Sheet, 26 May, 2008.). The Science Board agenda also includes comparative effectiveness and nanotechnology, as well as device-specific issues. Politics and Progress Comparative effectiveness research has come under intense political scrutiny recently due to a perceived connection with the politics of health-care reform and the Affordable Care Act. In passing the budget for the rest of fiscal 2011 last month, Congress called for a Government Accountability Office audit of CER funding. The report would quantify the expenses and describe who received the funding and to what purpose (Also see "FDA Funds To Rise Despite Widespread Reductions In 2011 Appropriations" - Medtech Insight, 18 Apr, 2011.). Less politically sensitive could be a discussion of progress on FDA's Janus database, which is intended to help produce faster reviews of new drug and device applications. Construction of the data warehouse was funded last year from $1.1 billion appropriated for CER under the American Recovery and Reinvestment Act (Also see "God Of Gateways: Will FDA's Massive Janus Database Drive Review Efficiency Or Comparative Effectiveness Research?" - Pink Sheet, 24 May, 2010.). As to nanotechnology, the Science Board seems likely to give its input on an agency-wide guidance on the subject for manufacturers of all FDA-regulated goods. Linda Katz, director of FDA's Office of Cosmetics and Colors, recently said this guidance is being finalized and will be released before any "product-specific" guidances (Also see "FDA’s Lead-In-Lipstick Testing Completed, Cosmetics Director Says" - HBW Insight, 25 Apr, 2011.). President Obama requested $1.2 million for nanotechnology activities, including scientific staff development and training, product testing capability and research, in the 2012 budget proposal he sent to Congress in February ('2012 Budget Request Would Fund Device Surveillance,' 'The Gray Sheet,' Feb. 16, 2011). -Martin Berman-Gorvine ( [email protected] ) |