FDA's LIST OF DRUGS MARKETED WITHOUT APPROVED NDAs

FDA's LIST OF DRUGS MARKETED WITHOUT APPROVED NDAs includes one group of 2,400 products dominated by "grandfather" drugs originally marketed before 1938. The largest of three categories making up a list of 5,150 drugs, the "grandfathered" products represent almost half of all drugs marketed without approved NDAs. The grandfather drugs include such items as digitalis, codeine, atropine, thyroid and phenobarbital. FDA prepared the 1,524-page list of unapproved products in response to a request by Rep. Weiss (D-NY) as a follow-up to his May 4 House hearing on E-Ferol, the injectable vitamin E product that was linked to a series of fatalities in premature infants. The second largest category of Rx drugs marketed without an approved NDA are products under DESI review, an estimated 1,800. FDA emphasized "it should be noted that the list of drugs found in this category will be changing rapidly as the future final determinations of efficacy are made . . . and subsequent enforcement class actions are taken." An estimated 950 products don't fall under FDA's DESI review or the grandfather exemption, FDA noted. "Many of these are believed to be products for which no NDA or ANDA is required at all, and therefore, are not subject to the drug listing requirements." For example, FDA said, "more than 400 are Rx biologicals that have been approved under FDA's licensing mechanism rather than the NDA or ANDA mechanisms." Other products in the category "include those which are marketed either as Rx or OTC drugs pending completion of the ongoing review of OTC drugs, certain oral vitamin products for which the food/drug status is still under review, and products which are medical diagnostics." FDA explained that the computer-generated list was compiled from unapproved products contained in the agency's drug listing files as of June 1984. "Because of a time-lag with respect to the reporting of NDA approvals to the system, some recently approved products may be listed as unapproved," the agency said. In addition, "there is often a time-lag between firm's discontinuance of a marketed product and the date that product is delisted from FDA's files." FDA estimated the list is "approximately 95% accurate."