Challenges for the FDA The Future of Drug Safety: Workshop Summary (2007) / Chapter Skim
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Appendix A Workshop Agenda
Appendix A Workshop Agenda
Pages 81-92
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From page 81... ...
which were deemed to have significant resource implications -- these are grouped into five topic areas: increased FDA funding; integration of pre- and postmarket review; enhancing postmarket safety monitoring; conducting confirmatory drug safety and efficacy studies; and enhancing postmarket regulation and enforcement. The complete list of recommendations can be found in the report or the executive summary at http://www.nap.edu/ catalog/11750.html.
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Jane henney Senior Vice President and Provost for Health Affairs University of Cincinnati Academic Health Center Former Commissioner of Food and Drugs, U.S. Food and Drug Administration
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steve Galson Member, Forum on Drug Discoery, Deelopment, and Translation Director, Center for Drug Evaluation and Research U.S. Food and Drug Administration 8:50 am Q&a Session 2: Integration of Pre- and Postmarket Review Session Objectives: The IOM Drug Safety report recommends adoption of a lifecycle approach to drug review, including integration of pre- and postmarket review (Recommendations 3.4, 4.4, 4.5, 4.13, and 5.4)
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Food and Drug Administration 9:55 am Industry's role in the institution of a lifecycle approach to drug safety review. tim Franson Vice President, Global Regulatory Affairs Lilly Research Laboratories Eli Lilly and Company 10:05 am Q&a 10:35 am Break
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Presentations will also consider ways to leverage existing resources to enhance postmarket safety monitoring, including the innovative use of databases and resources from other agencies, health plans, and industry. 10:50 am Overview of key IOM recommendations and introductions.
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ron krall Member, Forum on Drug Discoery, Deelopment, and Translation Senior Vice President and Chief Medical Officer GlaxoSmithKline 12:00 pm Q&a 12:30 pm Lunch/Roundtable Discussion Session 4: Conducting Confirmatory Drug Safety and Efficacy Studies Session Objectives: The FDA is limited in its ability to conduct studies on drugs that are already approved to assess the safety concerns or efficacy of drugs in clinical use. The IOM drug safety report calls for the development of public–private partnerships to prioritize, plan, and fund confirmatory drug safety and efficacy studies (Recommendation 4.3)
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roBert CaliFF Member, Forum on Drug Discoery, Deelopment, and Translation Director, Duke Translational Medicine Institute Professor of Medicine Vice Chancellor for Clinical and Translational Research Duke University Medical Center 2:00 pm Enhancing the value of clinical trial registration. deBorah zarin Director, ClinicalTrials.gov National Library of Medicine 2:10 pm An industry perspective on expanding the capacity for postmarket studies and regulation of ClinicalTrials.gov.
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. This session will describe how the FDA currently deals with concerns about drugs that are on the market, will consider various approaches to enhancing the FDA's ability to regulate drugs following approval, and will examine the resource implications for both the FDA and industry of alternative approaches.
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4:05 pm Q&a Session 6: Drug Safety Regulation: Looking to the Future Session Objectives: Panelists will reflect on the challenges and opportunities for enhancing drug safety discussed throughout the day, and share their thoughts on the steps necessary to ensure the continued ability of the FDA to meet the challenge. 4:40 pm myrl WeinBerG President National Health Council 4:50 pm mark mCClellan 5:10 pm Q&a Closing Remarks 5:20 pm Gail Cassell, symposium Chair 5:30 pm Adjourn
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4.13: The committee recommends that the CDER review teams regu larly and systematically analyze all postmarket study results and make public their assessment of the significance of the results with regard to the integration of risk and benefit information. 5.4: The committee recommends that FDA evaluate all new data on new molecular entities no later than 5 years after approval.
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Session 4: Conducting Confirmatory Drug Safety and Efficacy Studies 4.3: The committee recommends that the Secretary of HHS [Health and Human Services] , working with the Secretaries of Veterans Affairs and Defense, develop a public-private partnership with drug spon sors, public and private insurers, for-profit and not-for-profit health care provider organizations, consumer groups, and large pharmaceu tical companies to prioritize, plan, and organize funding for confir matory drug safety and efficacy studies of public health importance.
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5.3: The committee recommends that Congress amend the Food, Drug and Cosmetic Act to require that product labels carry a special symbol such as the black triangle used in the UK or an equivalent symbol for new drugs, new combinations of active substances, and new systems of delivery of existing drugs. The Food and Drug Administration should restrict direct-to-consumer advertising during the period of time the special symbol is in effect.
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