Trends in U.S. regulatory approvals of the biopharmaceutical therapeutic entities

Pharmaceutical productivity, as measured by annual output of new molecular entities and new therapeutic biologics, has fallen significantly since reaching a peak in 1996. According to Food and Drug Administration (FDA) data, the number of new drug approvals (new molecular entities and new biologics) fell from 50 in 1996 to 29 in 2003 (FDA-BEP database 2004). Meanwhile, non-inflation adjusted expenditures for research and development have almost doubled (PhRMA 2004). This thesis uses time series analysis to characterize historical trends in new drug introductions. Linear modeling and ARIMA modeling are employed to show that the large increase in new drug approvals in 1996 is inconsistent with previous trends. The hypothesis that the 1996 increase in new drug approvals is the consequence of additional FDA processing capacity pursuant to the implementation of the Prescription Drug User Fee Act (PDUFA) is considered and rejected, based on an analysis of the underlying causes of the increase. Next, approval trends before and after the implementation of PDUFA are compared. Notably, the percentage of new drug applications resulting in approval has increased since the implementation of PDUFA while the number of applications reviewed per year has not changed significantly. The relationship between the success ratio and drug withdrawal rates is examined, with inconclusive results.

Department dc:contributor.department

Harvard University--MIT Division of Health Sciences and Technology.

Grantor dc:publisher

Massachusetts Institute of Technology

Year dc:date.issued

2005

Author dc:creator

• Graham, James B., 1976-

Advisor dc:contributor.advisor

• Ernst R. Berndt and Issac S. Kohane.

• Harvard University--MIT Division of Health Sciences and Technology.

Statement dc:rights

• M.I.T. theses are protected by copyright. They may be viewed from this source for any purpose, but reproduction or distribution in any format is prohibited without written permission. See provided URL for inquiries about permission.

Licence dc:rights.uri

• http://dspace.mit.edu/handle/1721.1/7582

Language dc:language.iso

eng

Handle dc:identifier.uri

http://hdl.handle.net/1721.1/30276

OAI identifier oai:identifier

oai:dspace.mit.edu:1721.1/30276