About Andrew Mosholder Consulting

Mission: To provide expert consultation and guidance regarding real world evidence, pharmaceutical development and regulation, pharmacoepidemiology and drug safety, and related areas. 

I began this consulting service after retiring from the Food and Drug Administration with 32 years of experience as a medical officer and epidemiologist. My career with FDA provided me with extensive experience in the design and conduct of observational studies, drug safety and pharmacovigilance, and use of real world data.

Andrew D. Mosholder, MD, MPH

Brief bio sketch

32 years at FDA’s Center for Drug Evaluation and Research

·      Experience in new drug review and postmarketing safety surveillance

·      Presented at more than a dozen FDA Advisory Committee meetings

Education and training

·      University of Virginia School of Medicine (MD)

·      Johns Hopkins Bloomberg School of Public Health (MPH)

·      Clinical training in adult and child psychiatry (board certified in both)

Key skills and experience

·      Design, conduct and evaluation of pharmacoepidemiologic studies

·      Evaluation of Real World Evidence proposals

·      Drug safety signal evaluation

·      Design and interpretation of clinical trials

·      Psychiatric drug development

·      Evaluation of risk mitigation strategies

Selected recent publications

Mosholder AD, Izurieta HS, Zhang R, et al. Use of proton pump inhibitors and risk of severe COVID-19: A case-control study in United States Medicare beneficiaries. Pharmacotherapy 2024; 44:803-810.

Mosholder AD, Hada M, Leishear K. Proton-Pump Inhibitors and Cardiovascular Adverse Events: A Meta-Analysis of Randomized Controlled Trials. Am J Gastroenterol 2025; 120:362-369.  

Perez-Vilar S, Mosholder AD, Smith ER, et al. Antipsychotics and Risk of Acute Respiratory Failure in U.S. Medicare Beneficiaries with Chronic Obstructive Pulmonary Disease. J Gen Intern Med 2025; 40:587-594.

Mosholder AD, Ma Y, Akhtar S, et al. Mortality Among Parkinson's Disease Patients Treated With Pimavanserin or Atypical Antipsychotics: An Observational Study in Medicare Beneficiaries. Am J Psychiatry 2022; 179:553-561.

Apata J, Lyons JG, Bradley MC, Ma Y, Kempner ME, Kim I, Eworuke E, Pennap D, Mosholder A. Assessing the risk of intentional self-harm in montelukast users: an updated Sentinel System analysis using ICD-10 coding. J Asthma 2024;61:653-662.