Prior to the 1962 amendments of the Food, Drug, and Cosmetic Act, which
considerably enhanced the FDA’s powers, the average time from the filing of a New
Drug application to its approval was seven months. The 1962 amendments gave the
FDA authority to prescribe how the drug companies must conduct their clinical trials,
adding years to the development process. Time to approval, which now included approval
of an Investigational New Drug application (for conduct of the clinical trials) as
well as a subsequent New Drug application, continued to rise, reaching 6.5 years in
the 1970s, 8.3 years in the 1980s, and 8.9 years for the period 1990–96 (Tufts Center
for the Study of Drug Development 1998).9
Time to approval is typically shorter by years in Europe than in the United States, and as a result drugs are often available in
Europe long before they are available in the United States.10 The difference between
the time of a drug’s availability in Europe and that in the United States has come to be
called the “drug lag” (Wardell 1973, 1978a, 1978b; Wardell and Lasagna 1975;
Kaitin and others 1989; Grabowski 1980).
Deaths due to the drug lag have been numbered in the hundreds of thousands.
Wardell (1978a), for example, estimated that practolol, a drug in the beta-blocker
family, could save ten thousand lives a year if approved in the United States. Although
the FDA first approved a beta blocker, propranolol, in 1968, three years after that
drug had become available in Europe, it waited until 1978 to approve propranolol for
the treatment of hypertension and angina pectoris, its most important indications.
Despite clinical evidence available as early as 1974, only in 1981 did the FDA approve
a second beta-blocker, timolol, for prevention of second heart attack. The agency’s
dilatory action with regard to beta blockers alone was thus responsible for probably
tens of thousands of deaths.