Title: The development and regulation of new medications.

POPLINE Document Number: 050249

Author(s):

Lasagna L

Source citation:

SCIENCE, 1978 May 26;200(4344):871-3.

Abstract:

The unmet needs of many patients make the successful search for new and better drugs an urgent goal. Increasing regulatory demands in the U.S. have generated delays in the availability of new drugs and concerns about the long-term profitability of the pharmaceutical industry. It now takes an American firm about 8 years and $54 million to bring one of its new drugs to the U.S. market. A rational and flexible approach to drug regulation could ease some of the most worrisome constraints without jeopardizing the public welfare. Over-the-counter drugs and old and proven drugs should not be subject to the same rigid testing requirements as new prescription drugs. Money saved in this area could be put to use in expediting the search for new drugs. The Food and Drug Administration requires that 2 controlled trials of new drugs be conducted, regardless of the number and quality of foreign trials already available. This requirement should be eliminated. Changes in our national drug regulatory policy will serve our society better than legislative proposals intended either to emasculate the Food and Drug Administration or to grant the agency broad new powers. (author's modified)

Keywords:

United States
Drugs
Government
Government Agencies
Legislation
Industry
Marketing
Research and Development
Product Approval
Developed Countries
North America
Americas
Treatment
Political Factors
Organizations
Macroeconomic Factors
Economic Factors
Technology