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Rx-TO-OTC SWITCH LEGISLATION URGED

Executive Summary

Rx-TO-OTC SWITCH LEGISLATION URGED as part of an omnibus health care reform legislative program for President-elect Bush to pursue early in his administration. "The new President should propose reforms to allow more prescription drugs with proved records of safety and effectiveness to be sold over the counter," the conservative Heritage Foundation think-tank said. The recommendation is contained in a chapter on health care distributed prior to publication of the group's "Mandate for Leadership III," a set of government wide policy recommendations which will be published in January. Explaining its support for more Rx-to-OTC switches, the Heritage Foundation said: "There is already a growing trend toward more self-medication using nonprescription drugs and home diagnostic tests, and in recent years FDA has permitted more drugs to be sold without a prescription. The evidence indicates that consumers support these changes and use the medications responsibly." The recommendation on Rx-to-OTC switches is one of three specific policy reforms affecting FDA that are being urged by the Heritage Foundation. The group called for amendments to the FD&C Act to reform FDA procedures for making drugs available to terminally ill patients, and for reform of food safety regulations to establish standards for determining acceptable levels of carcinogens in foods. The group maintained that current FDA drug and food regulations need to be reformed because they "inflict excessive burdens on the food and drug industries and ill serve the consumer." As a first step to reform, Heritage recommended that "the new President should propose amendments to allow patients with terminal or life-threatening illnesses to use unapproved drugs on an informed consent basis and to permit limited domestic production and sale of such drugs for this purpose." Under Bush's sponsorship, the agency has just completed its proposal for expedited approval of drugs that fit similar criteria. Because of the Delaney Act, FDA currently is not allowed to approve food products that contain carcinogens in any detectable amount, the group pointed out. However, because of improved technology, "trace amounts of carcinogens that in earlier years went undetected can now be identified in many food products, though the risk of their causing cancer is, at most, negligible." Because "FDA in many cases has ignored these regulations" the food industry is "in the difficult position of trying to meet what are in effect arbitrary standards." To solve this problem, Heritage said, the new Administration "should propose a clearer and more reasonable standard for determining acceptable levels of carcinogens in food products." The principle author of the health chapter of The Heritage Foundation book is Ronald Docksai, head of Merrell Dow's Washington office. Docksai was formerly chief health staffer for Sen. Hatch (R-Utah) before moving to HHS in 1986 as assistant secretary for legislation.
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