United States Government Accountability Office
Report to Congressional Requesters
Issues Cited as
What GAO Found
Why GAO Did This Study
Accountability Integrity Reliability
NEW DRUG DEVELOPMENT
Science, Business, Regulatory, and
Intellectual Property Issues Cited as
Hampering Drug Development Efforts
Highlights of GAO-07-49, a report to
Although the pharmaceutical industry reported substantial increases in
annual research and development costs, the number of NDAs submitted to,
and approved by, FDA has not been commensurate with these investments.
From 1993 through 2004, industry reported annual inflation-adjusted
research and development expenses steadily increased from nearly
$16 billion to nearly $40 billion—a 147 percent increase. In contrast, the
number of NDAs submitted annually to FDA increased at a slower rate—
38 percent over this period. Similarly, the number of NDAs submitted to FDA
for NMEs increased by only 7 percent over this period. FDA approved most
NDA applications—76 percent overall, but the numbers of NDAs and NDAs
for NMEs it approved annually have generally been declining since 1996.
Research and Development Expenses, Total NDA, and NDA for NME Submissions, 1993-2004
According to experts, several factors have hampered drug development.
These include limitations on the scientific understanding of how to translate
research discoveries into safe and effective drugs, business decisions by the
pharmaceutical industry, uncertainty regarding regulatory standards for
determining whether a drug should be approved, and certain intellectual
property protections. These factors have been cited as affecting the number
of drugs developed, the cost and length of the drug development process, as
well as the types of drugs being produced.