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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research
Activity Outline
FDA Drug Topics: The Bad Ad Program
September 24, 2024
Zoom

Activity Coordinators:
Thanh Nguyen-Chu (Thanh.Nguyen-Chu@fda.hhs.gov),  Kara Burke (Kara.Burke@fda.hhs.gov),  Kimberly De Fronzo (Kimberly.Defronzo@fda.hhs.gov)
Series Description

FDA's Division of Drug Information in the Center for Drug Evaluation and Research (CDER) sponsors a series of educational webinars targeting the needs of health care professionals and students. The webinars cover a broad range of FDA drug regulation and medication safety topics. These focused webinars support FDA's mission of promoting and protecting public health through interaction and education to strengthen current and future partnerships and relationships with clinicians and researchers.

Lecture Description
There are several innovative opportunities to collaborate with the FDA. This webinar will focus in on the FDA's Bad Ad Program. It will provide an overview of prescription drug promotion and its regulation along with information on how healthcare professionals can report potentially false or misleading prescription drug promotion to the FDA.
References
  • Kantar Media. Syneos Health™ Promotional Answers. Data on file (2022).
  • The Bad Ad Program: https://www.fda.gov/drugs/office-prescription-drug-promotion/bad-ad-program
  • The Office of Prescription Drug Promotion: https://www.fda.gov/about-fda/cder-offices-and-divisions/office-prescription-drug-promotion-opdp
  • FDA Warning Letters and Notice of Violation Letters to Pharmaceutical Companies: https://www.fda.gov/drugs/enforcement-activities-fda/warning-letters-and-notice-violation-letters-pharmaceutical-companies
Series Objectives
  • Explain how to utilize FDA's Drug Information, medication safety resources, and regulatory guidances to improve delivery of patient care and optimize outcomes.
  • Describe and inform health care providers of recent labeling, policy and regulatory changes which would impact prescribing and medication management to optimize patient care.
Learning Objectives After completion of this activity, the participant will be able to:
  • Discuss FDA’s role in regulating prescription drug promotion
  • Describe the role that healthcare professionals (HCPs) can play in protecting the public health by recognizing potentially false or misleading prescription drug promotion
  • Explain how HCPs can effectively report potentially false or misleading prescription drug promotion to the FDA through the Bad Ad Program
Target Audience
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health (CPH), and physician assistants.
Registration Information
Registration is complimentary; therefore refunds are not applicable. For information on how to register to attend this activity, please contact the Activity Coordinator(s) listed above.
Agenda

Lecture 1 September 24, 2024
Time Topic Speaker
1:00 - 2:00 PM EDT The Bad Ad Program Adesola Adejuwon, PharmD, MBA
Continuing Education Accreditation
Jointly Accredited Provider
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
ICPE Credit
This activity was planned by and for the healthcare team, and learners will receive 1 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 1.00 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-24-002-L99-P, and ACPE Universal Activity Number JA0002895-0000-24-002-L99-T for 1.00 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).
AAPA
This activity is designated for 1.00 AAPA Category 1 CME credits. FDA Center for Drug Evaluation and Research has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. PAs should only claim credit commensurate with the extent of their participation.
CPH
Up to 1.00 CPH Recertification Credits may be earned at this event.
Requirements for Receiving CE Credit

All learners claiming credit must attest to their attendance and complete all required activity evaluation(s) in the FDA CE Portal (ceportal.fda.gov) within 14 days after an activity ends. Upon completion, learners may view/print statement of credit.

Attention NABP Pharmacists and Pharmacy Technicians: The FDA CE Team will report your credit to the National Association of Boards of Pharmacy (NABP) provided you add your NABP ID and date of birth to your profile in the FDA CE Portal. The only official Statement of Credit is the one you pull from CPE Monitor. If you do not see your credit reflected on CPE Monitor* after 45 days of attestation, please contact FDACETeam@fda.hhs.gov. *CPE Monitor sets a strict 60-day limit on uploading credits.

Disclosure

Faculty
  • Adejuwon, Adesola, PharmD, MBA, Regulatory Review Officer, FDA - nothing to disclose

Planning Committee
  • Burke, Kara, PharmD, Team Leader/Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
  • Cao, Christian, MPAS, PA-C, Cross-Discipline Safety Advisor, FDA/CDER/OSE/OPE - nothing to disclose
  • De Fronzo, Kimberly, RPh, MS, MBA, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose
  • Kapoor, Rama, MD, Senior Physician, FDA - nothing to disclose
  • Nguyen-Chu, Thanh, PharmD, Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
  • Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose

CE Consultation and Accreditation Team
  • Littlefield, Jr, Kenneth P., Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
  • Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
  • Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose
Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.