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ESTROGEN PATIENT PACKAGE INSERTS WILL INCLUDE GENERAL CATEGORIES

Executive Summary

ESTROGEN PATIENT PACKAGE INSERTS WILL INCLUDE GENERAL CATEGORIES of information rather than the current specific information requirements under regulations proposed by FDA. The agency said in a proposed rule in the Oct. 9 Federal Register that it wants to "transform the estrogen patient package insert regulation from a listing of specific items to be included in the patient package insert to an enumeration of general categories of information to be included." The agency predicted that the change would "make it easier for manufacturers to update patient package inserts to reflect new information about the benefits and risks of estrogen drug use." The agency explained that the original estrogen patient package insert regulation issued in 1977 contained detailed descriptions of the information which was required. FDA noted, however, that because of the detail of those regulations, notice and comment rulemaking would be required in order to update the inserts with new information on risks and benefits of estrogen products. The proposed revision in the regulation would facilitate the communication of new information to estrogen product users, FDA said. Under the proposal, estrogen patient package inserts would now be required to contain information in eight general categories of information. In addition to such information as the name of the drug and the manfacturer, the proposal would require statements concerning when estrogens should and should not be used; "a description of the most serious risks associated with use of estrogens"; "a brief summary of other side effects of estrogens"; and "instructions on how a patient may reduce the risks of estrogen use." In a separate notice in the Oct. 9 issue of the Federal Register, FDA announced the availability of guidelines that conform to the proposed regulation. FDA noted that the new information required in the inserts will include "information on the use of estrogens to treat postmenopausal osteoporosis as well as findings regarding the use of progestogens with estrogens." The agency said it was also proposing to change the requirements concerning distribution of patient package inserts to allow greater flexibility. The proposed rule "would permit distributors of estrogens to adopt whatever distribution method they choose, provided every person in the distribution chain receives an adequate number of patient package inserts to meet his or her obligations." Currently, FDA explained, the regulations require that inserts "physically accompany the drug product from the manufacturer or labeler through the wholesaler to the dispenser of the product."
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