Pharmacy Administration, Policy and Regulation Commons^™

Timing Of New Black Box Warnings And Withdrawals For Prescription Medications, Karen Lasser, Paul D. Allen, Steffie Woolhandler, David U. Himmelstein, Sidney M. Wolfe, David H. Bor

Publications and Research

Context Recently approved drugs may be more likely to have unrecognized adverse drug reactions (ADRs) than established drugs, but no recent studies have examined how frequently postmarketing surveillance identifies important ADRs.

Objective To determine the frequency and timing of discovery of new ADRs described in black box warnings or necessitating withdrawal of the drug from the market.

Design and Setting Examination of the Physicians' Desk Reference for all new chemical entities approved by the US Food and Drug Administration between 1975 and 1999, and all drugs withdrawn from the market between 1975 and 2000 (with or without a prior black …

Pharmaceuticals: Access, Cost, Pricing, And Directions For The Future, Patricia M. Danzon, Stephen B. Soumerai

Center for Policy Research

Prescription drug expenditures make up less than 10 percent of total personal health care expenditures in the United States, but over the last decade the amount that Americans spend on prescription drugs has grown much faster than any other component of personal health care. For example, between 1999 and 2000, hospital care costs rose about 5 percent, physicians and clinical services 6 percent, while prescription drug expenditures climbed more than 17 percent. In dollar amounts, prescription drug expenditures doubled, from $61 billion to $122 billion, between 1995 and 2000. Is this an unwarranted expense that needs to be controlled, or …