For Health Professionals

2012 Health Professional Organizations Annual Conference

The FDA Office of Special Health Issues (OSHI), Health Professional Liaison Program hosted the Second Annual Health Professional Organizations Conference in collaboration with the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH) on Thursday, October 4, 2012, from 9:00 a.m. to 4:00 p.m. at the FDA White Oak Campus in Silver Spring, Maryland.

Registrants representing approximately 35 health professional organizations and one representing industry attended the conference. In total, approximately 60-70 people, including registered guests and FDA staff, attended the conference.

Slide presentations offered in pdf format where available.

Morning Session

Welcome FDA’s Health Professional Liaison Program

Heidi C. Marchand, PharmD, Assistant Commissioner for Office of Special Health Issues
This presentation provided an overview the Office of Special Health Issues, as well as highlighting current Office initiatives underway including the MedWatch Practice Portal and the new Consumer-friendly MedWatch Form, both scheduled to rollout within the coming months. 

FDA Safety and Innovation Act Update (PDF: 54KB)

Jeanne Ireland, Associate Commissioner for Legislation 
This session provided an overview of the Food and Drug Administration Safety and Innovation Act including cost and budgeting considerations for the Agency, increased stakeholder involvement and other elements of the bill that affect Agency activities. 
Comments from the audience included questions regarding details of the legislation and how it will impact current regulations and processes in place at the Agency. 

Public/Private Partnerships

Michelle McMurray-Heath, MD, PhD, Associate Director for Science, CDRH
This presentation provided an overview of Network of Experts program in the Center for Devices and Radiological Health (CDRH). This program is designed to be an additional tool for gathering external expertise in a rapidly accessible and efficient manner. The goal is to allow CDRH staff to tap into a virtual network of scientific experts within a limited period of time to define a scientific question that CDRH staff needs to address quickly.
Comments from the audience included inquiries about expertise needed by the Agency, details surrounding participation in the program and general questions about the enrollment process.  

Perspectives on FDA Network of Experts Program

Lisa Goldstein, JD, American College of Cardiology  [ACC Perspective presentation (PDF: 160KB)]
Phillip Bongiorno, The Society of Thoracic Surgeons  [STS Perspective presentation (PDF: 103KB)]
The presentation included perspectives and experiences from two organizations participating in the Network of Experts including the American College of Cardiology and the Society of Thoracic Surgeons.
Comments from the audience included inquiries about the program and how organizations can participate.

Afternoon Breakout Sessions

Speed Networking

Anna Fine, Director of OSHI’s Health Professional Liaison Program (Moderator) 
This session provided a great networking opportunity for FDA staff and meeting participants. Approximately 20 individuals interacted one-on-one in five separate sessions of timed exchanges with FDA staff from various Centers and Offices.

FDA Advisory Committee: Obtaining Outside Expert Advice (PDF: 303KB)

OC/Office of Special Medical Programs
Michael Ortwerth, PhD, Director, Advisory Committee Oversight and Management Staff
This session allowed participant to understand general information on the FDA’s advisory committee program; relevant laws and regulations; roles of members on a committee; public participation at committee meetings; and how to submit a nomination for a vacancy on an advisory committee. 
Comments from the audience included inquiries into the Advisory Committee nomination process, the structure of the committees, and other questions about the advisory committee process.

MedWatch: Why Every Report is Important (PDF: 1.3MG)

CDER/OSE/Division of Pharmacovigilance
Ann Corken Mackey, RPh, MPH, Safety Evaluator Team Leader
Anissa Ferguson, PharmD, MS, Safety Evaluator
Tracy Salaam, PharmD, Safety Evaluator
The session included discussion of how FDA characterizes safety data collected, signal identification and the safety parameters at each stage of evaluation. Discussion included information about FAERS, the FDA’s internal adverse event database for all spontaneous reports. There was an interactive discussion about FDA gateway for clinically important safety information and reporting of serious problems with human medical products. A case example was presented from the perspective of a patient’s family or health professional.
Comments from the audience included details about the reporting process and the MedWatch reporting form.

Protecting Patients from Counterfeit and Other Substandard Drugs/Supply Chain Threats (PDF: 1.3MB)

CDER/OC/Office of Drug Security, Integrity and Recall
Connie Jung, RPh, PhD, Acting Associate Director for Policy and Communication
Jean McCue, Regulatory Counsel
This session examined FDA concerns about increasing vulnerability of U.S. drug supply to a variety of illegal activities that could have serious public health implications, ranging from diversion and theft of legitimate drugs to drug counterfeiting. FDA is focusing on strategies to educate health care professionals about supply chain risks and protect patients from unsafe, ineffective, or otherwise dangerous drugs.
Time was limited following presentation delivery and subsequently, no questions were asked following this session. Usability and Content Discussion (PDF: 789KB)

OEA/Office of Public Affairs
Chris Mulieri, Director, Web Communications
Dan Luxenberg, Program Analyst, Web Communications 

Consumer Information Available for Your Patients (PDF: 764KB)

Jason Brodsky, Director, Consumer Health Information Staff 
This interactive two-part session shared the results and request for feedback on our recently completed focus group project with FDA.GOV’s target audiences as well as discussions about consumer information available to the public. In the first part of the session, presenters shared “top tasks” that Health Professionals identified during the sessions and asked participants for additional ideas on ways to improve the Web site to ensure we are providing the information needed to target audiences. The second part of the session focused on consumer health information available for health professionals to give patients and provided an opportunity for participants to provide feedback on what patient information they find most useful.
Comments from the audience included inquires about information provided by, stakeholder involvement in this process and communications strategies 

Partnering with Professional Societies: Increasing awareness about serious drug risks that are part of Risk Evaluation and Mitigation Strategies (REMS) (PDF: 161KB)

CDER/OSE/OMEPRM/Division of Risk Management
Cynthia L. LaCivita, PharmD, Senior Drug Risk Management Analyst
Kate Heinrich Oswell, MA, Health Communications Analyst
This session focused on Risk Evaluation and Mitigation Strategies (REMS) and the various communication strategies that have been used to disseminate drug risk information to healthcare providers. Participants were encouraged to share effective ways to communicate with professional societies to the FDA, so their members are informed about REMS programs and serious drug risks. 
Comments from the audience included inquiries and recommendations about REMS formulation, communications and distribution strategies.

Non-prescription Safe Use Regulatory Expansion (NSURE) Initiative (PDF: 416KB)

OMPT/CDER/OMPI/Division of Medical Policy Programs
Rikin Mehta, PharmD, JD, Deputy Director, Division of Medical Policy Programs
On March 22-23, 2012, FDA held a public hearing, “Utilizing Innovative Technologies and Other Conditions of Safe Use to Expand Access to Nonprescription Drugs”, requesting comments on a proposed new paradigm. This concept explores the use of new technologies or other conditions of safe use allowing prescription drug products availability without a prescription, particularly to address undertreatment of chronic diseases. This session fostered interactive discussions about the NSURE Initiative with health professionals.
Comments from the audience included inquiries about the details of the NSURE program, how it would be initiated and potential challenges surrounding the concept.

Closing Session 

Breaking Updates on Fungal Meningitis Outbreak

Ilisa Bernstein, PharmD, JD, Acting Director, CDER Office of Compliance
This announcement updated the current number of cases of aspergillus meningitis including deaths, from  preservative free methylprednisolone compounded by New England Compounding Center/pharmacy (NECC). NECC products are being recalled and FDA is recommending immediate discontinuation. 

Conference Summary

Heidi C. Marchand, PharmD, Assistant Commissioner for Office of Special Health Issues
Review of the conference sessions, appreciations given to attendees for participating, and recognition to the Office of Special Health Issues Health Professional Liaison Team, led by Anna Fine, including Brenda Rose, Janelle Derbis, Christine Merenda and Cathy Miller, who together, coordinated and facilitated the second annual meeting for health professional organizations. 

Closing Remarks

Margaret A. Hamburg, MD, Commissioner, Food and Drug Administration
Dr. Hamburg provided a nice wrap up of the day’s events by recognizing these esteemed colleagues who participated in the conference (physicians, nurses, optometrist, pharmacists, physical therapists, nurse practitioners, physician assistants) and showed her appreciation for their support of the agency in public health and the productive day. Dr. Hamburg cited opportunities for new collaborations highlighting the conference agenda and organizations that attended, emphasizing the need for us to learn from each other, and encouraged participants to stay in contact through a variety of means, including relationships with the Office of Special Health Issues.
Meeting adjourned at approximately 4:20 PM

Contact FDA

Office of Health and Constituent Affairs

10903 New Hampshire Avenue

Bldg. 32, Room 5367

Silver Spring, MD 20993

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