Impact of FDA's Unapproved Drug Initiative on Drug Prices, Utilization and Outcomes: Focus on Colchicine

The FDA launched the Unapproved Drug Initiative in 2006, to remove unapproved drugs from the market. Under this initiative, various enforcement actions were taken against these drugs to remove them from the market. The initiative also gave an opportunity to manufacturers that if they conducted necessary studies and filed an NDA to obtain FDA-approval for their previously unapproved drug, then they will be granted with a limited market exclusivity during which other companies must cease manufacturing that drug within a certain grace period. The goal of this papers-based dissertation was to study the consequences of the FDA-UDI with a focus on colchicine. Three studies were developed to meet the research objectives. The aim of first study was to measure the impact of FDA-UDI on aggregate trends in prices, sales and quantities sold for drug products that obtained voluntary approval under this initiative. The second study evaluated the effect of market exclusivity and an associated price increase of approved colchicine on prophylactic colchicine initiation, adherence, gout-related healthcare resource utilization, and costs in patients with gout. Finally, the third study assessed the impact of the new labeling and prescribing information of single source of approved colchicine on potential colchicine interactions in patients taking colchicine. Overall, a marked increase was seen in post-approval prices and sales for most drug products approved in the FDA-UDI with mixed results in changes in units sold. In case of colchicine, it’s price increase reduced its initiation, but did not significantly impact adherence despite increased patient spending on colchicine. The availability of new labeling information of approved colchicine and removal of all unapproved colchicine from the market did not have an impact on potential colchicine interactions. In addition to increased information on safety, the policy's impact on post approval drug prices and associated effects on units sold should be considered in assessing the policy, especially when substantial price increases and decreases in units sold may negatively impact health. Policymakers should consider reforms for better dissemination of safety information to ensure safe use of drugs. Future studies should analyze the impact on other products impacted by this initiative.