Spending On Postapproval Drug Safety

MarketWatch Spending On Postapproval Drug Safety

Withdrawals of high-profile pharmaceuticals have focused attention on postapproval safety surveillance. There have been no systematic assessments of spending on postapproval safety. We surveyed drug manufacturers regarding safety efforts. Mean spending on postapproval safety per company in 2003 was $56 million (0.3 percent of sales). Assuming a constant safety-to-sales ratio, we estimated that ...

Spending on New Drug Development

This paper replicates DiMasi et al (2003, 2004) estimates of expenditure on new drug development using publicly available data. The paper estimates that average expenditure on drugs in human clinical trials is around $25m per year, with $18m per year on drugs in Phase 1, $33m on drugs in Phase 2 and $19m per year on drugs in Phase 3 of the human clinical trials. The paper’s estimated expenditur...

A New Focus on Prescription Drug Spending.

Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDA-mandated postapproval studies.

IMPORTANCE Postmarketing surveillance is critical to evaluating the safety and effectiveness of medical devices. The US Food and Drug Administration (FDA) may order the manufacturer of a high-risk device to conduct postmarketing surveillance studies, known as postapproval studies (PASs), at the time of approval. OBJECTIVES To understand the characteristics of PASs ordered in recent years and ...

Employer drug benefit plans and spending on prescription drugs.

CONTEXT With drug spending rising rapidly for working-aged adults, many employers and health insurance providers have changed benefits packages to encourage use of fewer or less expensive drugs. It is unknown how these initiatives affect drug costs. OBJECTIVE To examine how innovations in benefits packages, such as those that include multitier formularies and mandatory generic substitution, a...