3056.0 Drug & Pharmacy: Marketing & Monitoring

Monday, October 31, 2011: 8:30 AM
Additional research is needed to evaluate policy tradeoffs that inform public health decision-making, and ensure that scarce public dollars achieve the greatest value for money spent. The US Food and Drug Administration (FDA) conducts enforcement activities to protect the public health by assuring the safety, effectiveness, and security of pharmaceuticals. These enforcement activities include warning letters and notice of violation letters to pharmaceutical companies.
Session Objectives: 1. To explore a set of domestic drug policies, including FDA enforcement for safety and effectiveness; and cost containment efforts' effect on Medicaid expenditures; 2. To examine pharmaceutical companies' research and development approaches for cost savings; 3. To report on ethical dimensions of outsourcing clinical trials in light of international initiatives; 4. To discuss how the integration of such research findings may have implications for public health pharmacy practice

8:30 AM
Do multiple cost containment policies generate policy tradeoffs?
Jennifer Kibicho, PhD and Steven D. Pinkerton, PhD
8:50 AM
Exploring the Relationship between Drug Patent Life and Drug Approvals
Jing Hao, MPH, Rosa Rodriguez-Monguio, PhD and Enrique Seoane-Vazquez, PhD
9:10 AM
Clinical trials in developing countries: Implications for ethical conduct and research integrity
Meghana V. Aruru, PhD, MBA, BSPharm and Jack Warren Salmon, PhD
9:30 AM
Pharmaceutical-Related Warning Letters and Letters of Violation Released by the FDA between 1997 and 2010: Were they affected by Changes in the Federal Administration?
Diane Nguyen, Enrique Seoane-Vazquez, PhD, Rosa Rodriguez-Monguio, PhD, Michael Montagne, PhD and Bernard Tyrrell, Associate Professor

See individual abstracts for presenting author's disclosure statement and author's information.

Organized by: Medical Care
Endorsed by: Trade and Health Forum

CE Credits: Medical (CME), Health Education (CHES), Nursing (CNE), Public Health (CPH)

See more of: Medical Care