Center of Excellence in Regulatory Science and Innovation
The Yale-Mayo CERSI conducts high-quality, high-impact collaborative research to support several areas of focus in the FDA strategic plan for regulatory science. Research topic areas include: adoption/de-adoption of FDA-approved medical products, postmarket surveillance, development and application of novel analytics, and patient-centered regulatory decision-making.
Characterizing use, safety and efficacy of brand-name and generic drugs used to treat hypothyroidism
Generic drugs are approved based on bioequivalence to the brand name agents. However, there are sometimes concerns among patients and clinicians that generic and brand name drugs are not equivalent and have differing effects. Using a large administrative claims data source that includes information on privately insured and Medicare Advantage enrollees of all ages, we will characterize patterns of use of generic and brand-name L-thyroxine products and then compare the effectiveness and safety of generic and brand-name L-thyroxine among both new users and recent switchers.