Funding

Improving COPD Outcomes: Using Real-World Data to Analyze Treatment Effectiveness, Safety, and Adherence.

This grant investigates the comparative effectiveness and safety of therapies for chronic obstructive pulmonary disease (COPD) using large, longitudinal healthcare databases. The overarching goal is to supplement existing data from randomized controlled trials to refine treatment strategies for COPD and improve clinical outcomes.

RePORTER

The Safety of Switching Between Complex Branded and Generic Drugs: Developing a Semi-Automated Sequential Surveillance System Using Tree-Based Scan Statistics

This grant is developing a principled, scalable, and reproducible approach for rigorous and timely evaluation of the safety and effectiveness of generic drug-device combinations compared to brand-name reference products using large longitudinal healthcare datasets. We are demonstrating this approach for generating multi-phase actionable real-world evidence in 2-3 use cases, including description of utilization patterns, evaluation of comparative effects, and systematic screening for unsuspected safety issues. This project will provide the Food and Drug Administration with a reusable framework and set of tools for generating real-world evidence to evaluate complex generic drugs in the post-marketing setting.

RePORTER

Evaluating the FDA's 505(b)(2) Pathway: Approval Patterns, Patenting Strategies, and Opportunities for Reform

The FDA's 505(b)(2) pathway offers manufacturers a middle ground between traditional brand-name and generic approvals. It allows companies to bring reformulations to market by relying, in part, on existing evidence of safety and effectiveness, without necessarily meeting the standards required for generic substitutability. This pathway can encourage valuable innovations, including new indications and easier-to-use formulations for patients. But it can also be a vehicle for strategic gaming--with small modifications to existing products that support new patents while adding little clinical value. This project studies how the 505(b)(2) pathway shapes innovation, competition, and patient access, while identifying opportunities for policy reform.