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Government Day 2007

Agenda

5th Annual Government Day Meeting

Therapeutic Effectiveness in Research and Practice Strategies (TERPS)

March 14, 2007
FDA Offices - White Oak Campus

8:30 Welcome

• Dr. Doug Throckmorton, Deputy Director, CDER
• Dr. Hugh Tilson, University of North Carolina at Chapel Hill

8:40 The IOM Report "The Future of Drug Safety"

• Dr. Paul Seligman, FDA
• Dr. Robert Califf, Duke University

9:10 Questions and Answers

9:30 - 11:00 Breakout Sessions (descriptions following)

1. Off Label Use of Atypical Antipsychotic Drugs in Children Antidepressant Use and Suicidality

2. Challenges in Treatment of Rheumatic Diseases and Related Inflammatory Conditions

3. Risk Communication and Web Technology

4. Unmet Needs - Pediatric Device Development and Safety Surveillance

11:00 Break

11:15 Summaries of Breakout Sessions, Room 2047 and 2047E

12:15 Closing Remarks

• Dr. Jean Slutsky, Partnering for Safe and Effective Use of Therapeutics
• Dr. Hugh Tilson

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Breakout Session 1
Part 1: Off-Label Use of Atypical Antipsychotic Drugs in Children

Room 1315, WO
Leaders, Dr. Steve Crystal, Dr. Tom Laughren

Results of the 2/07 Consensus Conference on Outpatient Medication Management of Clinical Aggression in Youth conference will be presented, including a review of prescribing trends and epidemiological data; adverse drug events associated with atypical antipsychotic drugs in youth; and consensus treatment recommendations on priority knowledge gaps and research needs in the area.

This session will include a panel consisting of Dr. Laughren (FDA), Dr. Crystal (CERTs), and Dr. Benedetto Vitiello (NIMH), plus the speakers for the session: Drs. Mark Olfson and Elizabeth Pappadopulos (CERTs) and Dr. Christoph Correll (Albert Einstein College of Medicine/Hillside Hospital).

• Dr. Mark Olfson - Prescribing Trends and Epidemiological Data
• Dr. Christoph Correll - Adverse Drug Events
• Dr. Elizabeth Pappadopulos -- Consensus Development Process and Recommendations

Discussion issues include:

• strategies for prescriber education and policy to improve appropriateness and quality of medication use and management;
• gaps in knowledge base; and
• strategies and priorities for addressing gaps, including roles of observational studies and clinical trials.

Part 2: Antidepressant Use and Suicidality

Dr. Mark Olfson, from Rutgers, will present a new case control study, using national Medicaid datasets, that examines associations between antidepressant use and medically injurious suicide attempts in youth and adults initiating new episodes of treatment for major disorders. Dr. Olfson will also discuss other studies using observational data such as large administrative healthcare datasets. Dr. Thomas Laughren, Director of FDA's Division of Psychiatric Products, will discuss FDA's initiatives to re-examine this issue, including meta-analyses of pooled clinical trials. Key issues for discussion include:

• Significant knowledge gaps exist concerning the clinical use of psychiatric drugs regarding both safety (e.g. rare side effects such as suicidality in commonly treated disorders like depression) and effectiveness (e.g. scarcity of efficacy, safety/tolerability, and effectiveness data on the treatment of clinical aggression in youth).
• Randomized clinical trials represent the gold standard for assessing outcomes, but are often not available and may not generalize to a significant number of populations and treatment settings.
• What role can and should the analysis of large observational datasets play in filling these knowledge gaps?
• What are the specific circumstances under which observational data should be considered to fill these knowledge gaps (e.g. scarcity of clinical trial data, rare adverse effects, significant differences in drug utilization patterns between clinical trials and clinical practice)?

Breakout Session 2: Challenges in Treatment of Rheumatic Diseases and Related Inflammatory Conditions

Room 1410, WO
Leaders: Dr. Ken Saag, Dr. Jeff Siegel

Biological therapies have assumed an increasingly prominent role in the treatment of rheumatic and other inflammatory disorders. Despites their established efficacy for a variety of these conditions, safety concerns in both clinical trials and in postmarket surveillance have resulted in several boxed warnings as well as other risk communication efforts. Spontaneous reports, international registries and careful examination of administrative data represent some of the phase IV methods used for signal detection all possessing various strengths and weaknesses. Based on residual clinical and methodological issues surrounding these agents, both the FDA and the clinical community are critically evaluating optimal approaches to post-marketing surveillance of these unique compounds. This session will review existing regulatory procedures and controversies and provide examples of CERTs research on safety surveillance. The goal is to establish a dialogue between academic researchers (CERTs, DeCIDE, as well as other federal programs), federal regulators, and other interested parties around lessons learned and future agendas for improving public health in this area.

• Introductions and Overview - Dr. Ken Saag, University of Alabama
• Biological agents from the FDA perspective - Dr. Jeff Siegel, FDA
• Safety of Biologic Agents in RA: Can Claims Data be Used for Pharmacovigilence? - Dr. Jeffrey Curtis, University of Alabama
• Group Discussion
• Wrap up and preparation of report

Questions:

1. Third party payer databases are useful for assessing safety for common diseases and commonly prescribed medications. How well can they address safety issues concerning less common diseases and less commonly prescribed medications such as biologics?
2. For FDA: What types of questions typically arise in safety surveillance for biologic agents that a CERTS study might be able to help with?
3. For CERTS
1. What are some key aspects to formulating a research questions that would help you address questions posed by FDA?
2. Why types of questions lend themselves to study in the various databases available to CERTS Centers?
3. What standard procedures are used to identify positive and negative controls to help validate study results?
4. What are some of the challenges to carrying out and validating epidemiologic studies using third-party payer databases? For example:
1. How often is administrative data validated by medical record review?
2. How difficult is it to obtain and validate information on duration of treatment with particular pharmaceuticals /biologics?
3. How frequently is follow-up information unavailable because of patients leaving a care system?

Breakout Session 3: Risk Communication Using Web Technology

Room 1419, WO
Leaders: Dr. Michael Fordis, Dr. Paul Seligman

This breakout session will focus on utilization of the Internet to channel timely and comprehensible drug safety information to healthcare providers and possible methods and approaches that may be useful in evaluating whether we are reaching this target audience with appropriate drug safety information.

• MedWatch Partner Survey - Dr. Norman Marks, Medical Director, MedWatch, FDA
• Reaching Healthcare Providers using Web Technology - Carol S. Cavanaugh, MLS, CDER Web Program Manager, FDA
• Evaluating FDA Web Initiatives: Overview on Utilization, Reach and Evidence for Fostering Behavioral Change. What does the experience and research tell us? - Dr. Michael Fordis,

Questions

1. FDA speakers have described some proposed improvements in order to communicate better with health professionals via the Internet. In your opinion, which strategies will work and why? Please consider both the benefits and limitations in the proposed strategies. What special challenges will FDA face in improving the Web interface with healthcare providers? Please describe some predictive models that might leverage FDA strengths and also address the barriers and special challenges that have been discussed.
2. What are some practical approaches to evaluate that our messages are reaching healthcare providers and will achieve desired behavioral changes?
3. Please describe any past, ongoing or future ideas regarding research in web-based technologies that will advance the effective use of web-based tools and channels in reaching healthcare providers?

Breakout Session 4: Unmet Needs: Pediatric Device Development and Safety Surveillance

Room 1421, WO
Leaders: Dr. Sue Tolleson-Rinehart, Dr. Tom Gross

This session will generate discussion on issues related to unmet medical needs stemming from barriers to pediatric device development, as well as, unmet needs in terms of pediatric safety surveillance. A recent report to Congress, entitled "Barriers to Availability of Medical Devices Intended for the Treatment or Diagnosis of Diseases and Conditions that Affect Children", cites a problem with the widespread practice of modifying adult devices for pediatric use, the potential risk of that practice and the need for data on adverse events in children. FDA's Medical Product Surveillance Network (MedSun) has a cadre of pediatric hospitals and is exploring enhanced safety surveillance within these institutions. The focus of discussion will be on potential efforts that CERTs and FDA's MedSun may undertake to assess pediatric device needs and further explore pediatric safety surveillance.

• Barriers to Availability of Medical Devices for Children - Joanne R. Less, Ph.D./Associate Director, Clinical Research and Government Affairs/Center for Devices and Radiological Health, FDA
• Medical Product Surveillance Network (MedSun) - Marilyn Flack, M.A. / Director, Patient Safety Staff / Office of Surveillance and Biometrics / Center for Devices and Radiological Health / FDA

* FDA facilitator

• Tom Gross, MD, MPH/Director, Division of Postmarket Surveillance/Office of Surveillance and Biometrics/Center for Devices and Radiological Health/FDA

* CERTs facilitator

• Sue Tolleson-Rinehart, PhD/Co-Principal Investigator, UNC CERTs/Research Assistant Professor of Pediatrics and Public Health/Adjunct Professor of Political Science

Questions

1. A needs assessment has been proposed as a means to further assess barriers to availability of pediatric medical devices. In your opinion, what are the best means for achieving a meaningful needs assessment (one that takes into account the scope of pediatric specialties and that prioritizes those needs)? Does the proposed survey help in this regard? How might it be revised or best administered? What role might CERTS and MedSun play in furthering the needs assessment?

2. MedSun offers a new approach to surveillance. How might MedSun be optimally used to further explore pediatric safety surveillance? What role might CERTS play in furthering this effort?

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