
Tomas J. Philipson and George Zanjani
478
Table 8.3 Review of Literature Concerning the Effect of FDA Regulation on Safety
Source Data (Usually the
Dependent Variable)
Measure of FDA
Regulation
Baseline/Control Finding
Bakke et al. (1984) Drug discontinuations,
1964–1983
1962 Amendments UK Few discontinuations in either country so
no significant differences in discontinua-
tions in US vs. UK
Bakke et al. (1995) Drug discontinuations,
1974–1993
1962 Amendments UK, Spain More drugs discontinued in UK (20) and
Spain (16) than US (10). Normalizing by
number of drugs approved shrinks the
difference: 4% in UK vs. 3% in US
GAO (2002) Drug withdrawals,
1986–2000 ...