first edition (1980) of the Orange Book - FDA Law Blog

FOOD AND DRUG ADMINI STRATIONAPPROVED PRFS::RIPTION DRtX; PRODUCTS- With Therapeutic Equivalence Evaluations -I. PREFACEA. INTRODUCTIONThe Approved Prescription Drug Products list (the List) provides a listof currently marketed prescription drug products that have been approved formarketing on the basis of safety and effectiveness by the Food and DrugAdministration (FDA). In addition, it contains therapeutic equivalenceevaluations for multiple source drug products. These evaluations have beenprepared to pvomote public education in the area of drug product selection,to foster containment of health costs, and to serve state health agencies inthe administration of their drug product selection laws.For several years there has been a trend toward repeal of antisubstitutionlegislation that once was common in most States. In addition,most States have adopted laws intended to encourage or mandate the substitutionof one product of a particular drug entity for another, with the intentof saving money for the consumer and containing costs in drug procurementand medical reimbursement programs. These State laws generally require thateither substitution be limited to drugs on a specific list (the positiveformulary approach) or that substitution be permitted for all drugs exceptthose prohibited by a particular list (the negative formulary approach). .A number of States have sought the assistance of FDA in preparing bothposi ti ve and negati ve formular ies. For example, on January 23, 1978 FDAresponded to a request fDOm the New York State Health Department to evaluatetheir list of drug products for therapeutic equivalence. Subsequently, asimilar evaluation was made of a list suJ:mi tted by the State of Illinois.The basic policies awlied in evaluating these lists for the States of NewYork and Illioois are identical to the policies applied in developing thisList.Because of the number of requests for assistance in developing druglists fran other States, it became awarent that FDA could not serve theneeds of each State on an individual basis. The agency also recognized thata single list based on common policies would be preferable to attempting toevaluate drug products on the basis of differing definitions and criteria invarious State laws. As a result, on May 31, 1978, the Camnissioner of Foodand Drugs sent a letter to officials of all States informing them of FDA's