Drug lag

A few personal touches emerged to underline the drug lag issue, such as the FDA Commissioner s taking propranolol for hypertension at a time when it was not approved by the FDA for that purpose. Meanwhile, the more cautious... 

By the mid-1990s, after two decades of attention, the drug lag had been eliminated indeed, the pendulum had swung clearly in favour of the FDA. Whether due to the PDUFA resources, to the advent of more bureaucracy overseas (e.g. the formation of the European Union s central drug approval authority) or to criticism of delays at the agency, today the United States is often the first country to approve new drugs. 

While the drug lag debate was waning, a new challenge emerged to the FDA standards for drug effectiveness. This time, it was patient advocates who led the charge. 

Warden W. The Drug Lag and American therapeutics an international comparison. 22nd International Congress of Pharmacology, San Francisco, 1972. 

Warden W. Therapeutic implications of the drug lag. Clin Pharmacol Ther 1973 14 1022-34. 

The criticism appears to at least partially negate Peltzman s conclusion that the costs of the 1962 Amendments exceed their benefits — costs in Peltzman s study refer to "effective" drugs that do not reach the U.S. consumer and benefits refer to "ineffective" drugs kept off the U.S. market. Nevertheless, the speed at which drugs are granted market approval and the impact of FDA and its authority on drug innovation (the two parameters of the "drug lag") are still viable issues. 

Wardell, Drug Lag and American Therapeutics Wardell and Lasagna, Regulation and Drug Development. 

Andersson, F. The Drug Lag Issue The Debate Seen from an International Perspective. International Journal of Health Services 22 (1992) 53-72. 

Wardell, W, andL. Lasagna. The Drug Lag and American Therapeutics An International Comparison. Talk presented at the Fifth International Congress of Pharmacology, 26 July 1972. ----. Introduction ofNew Therapeutic Drugs in the United States and Great Britain An International Comparison. Clinical Pharmacology and Therapeutics 14 (1973) 773-90. 

Grabowski, H. G., Schweitzer, S.O., and Shiota, R., The Medicaid Drug Lag Adoption of New Drugs by State Medicaid Formulas, unpublished paper, Durham, NC, July 1990. 

Warden, W. M., The Drug Lag Revisited Comparisons by Therapeutic Area of Patterns of Drugs Marketed in the U.S. and Great Britain From 1972 Through 1976, Clinical Pharmacology and Therapeutics 24 499-524,1978. 

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