The "Drug export lag" and the Drug Export Amendments Act of 1986: an evaluation.
The purpose of this study was to evaluate the implementation of the Drug Export Amendments Act of 1986 (DEAA). The study methods involved calculating the time period between the submission of an application for export of a drug to the Food and Drug Administration (FDA) and its publication in the Federal Register, and the time taken by the FDA to reach a decision on the application. These parameters were then compared with the time limits specified in the DEAA. The analysis was conducted at four levels--overall for all pharmaceuticals, by therapeutic category of pharmaceutical, by country of export, and by type of company. At all four levels, we found that the publication and decision times were greater than the time limits specified in the DEAA. This suggests the existence of a "drug export lag," which includes a "publication time lag" (18.56 days) and an "FDA decision time lag" (182.26 days). The implications of these lags for the competitiveness of the US pharmaceutical industry in the global market are discussed and suggestions are provided.
Pathak
D S
DS
Division of Pharmaceutical Administration, College of Pharmacy, Ohio State University, Columbus.
Hakim
Z
Z
Kucukarslan
S
S
D000818:Animals; D004345:Drug Industry; D015507:Drugs, Investigational; D006801:Humans; D007391:International Cooperation; D017387:Investigational New Drug Application / Q000331:legislation & jurisprudence*; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
D015507:Drugs, Investigational