Monday, October 25, 1993
By Kris Herbst
WASHINGTON - Concerted efforts to induce companies to conduct rigorous pharmacoeconomic research on new products in addition to safety and efficacy studies have begun to emerge from industry and Capitol Hill.
Rep. Ron Wyden, D-Ore., calling for a "national campaign to discover the comparative effectiveness of medical technologies," is drafting legislation that would extend patent protection for companies that conduct FDA-approved studies comparing the clinical and pharmacoeconomic effectiveness of their new technologies to existing ones.
To provide other "significant incentives" for voluntary participation, Wyden's proposal also would expedite FDA approval when the studies show a product has an equivalent effectiveness at a cost that is less than already approved therapies.
Task force support
The director of an industry task force that is drafting guidelines for effectiveness research on biotechnology and pharmaceutical products testified in favor of Wyden's proposal at a congressional hearing last week.