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FOLIC ACID INFORMATION INCLUSION IN REVISED ORAL CONTRACEPTIVE PACKAGE INSERT

This article was originally published in The Tan Sheet

Executive Summary

FOLIC ACID INFORMATION INCLUSION IN REVISED ORAL CONTRACEPTIVE PACKAGE INSERT was suggested by committee member Jane Zones, PhD, University of California, at an Oct. 29 meeting of FDA's Fertility & Maternal Health Advisory Committee. During committee discussion on whether oral contraceptive labeling should include a section on "other reproductive or general health issues," Zones recommended that a paragraph be incorporated into that section encouraging women who discontinue OCs to make sure they consume adequate amounts of folic acid to reduce the risk of conceiving a child with neural tube defects. Zones, who is also a member of FDA's Folic Acid Subcommittee, offered a sample paragraph for the section that would read: "If you stop taking your birth control pills or are thinking of having a baby, you should make sure that you get enough of the vitamin folic acid. Having enough folic acid at the time you become pregnant and in the first month of pregnancy greatly reduces your chance of having a baby with a serious birth defect called [a] neural tube defect. Most multivitamin pills have the right amount of folic acid." FDA recently proposed to allow a health claim for folic acid-containing products ("The Tan Sheet" Oct. 11, p. 4). Adding a section on "other" health issues in OC patient labeling was initially offered as an option by FDA Medical Officer Lisa Rarick, MD. Rarick suggested that the section address issues such as breast self-examination, Pap smears and testing for sexually transmitted diseases. The committee generally approved of the idea but did not officially vote on it. Committee Chairperson Ezra Davidson, MD, Charles Drew Postgraduate Medical School, suggested that a separate meeting could be scheduled to discuss what elements could be included in that section. The committee did vote unanimously in favor of developing a one-page summary package insert for oral contraceptives -- an idea that could be germane if FDA continues to consider the possibility of an Rx-to-OTC switch of oral contraceptives. Agency officials have indicated that an OTC switch could be addressed by the Fertility & Maternal Health Advisory Committee in the future ("The Tan Sheet" May 24, p. 5). Picking up on a suggestion made in presentations to the committee, members agreed that OC patient labeling should include a one-page summary highlighting the most important instructions and referencing a second insert that would include the more detailed information currently found in the patient package insert. The group suggested that the simplified, one-page summary could either be printed on or attached to the unit-of-use packs of oral contraceptives. "If you can't get it all on one page, people won't read it," committee member Nancy Sharts-Hopko, PhD, Villanova University, commented. The committee did not recommend specific changes to simplify patient labeling. However, the group did vote that it "would like to review" a draft to be developed by FDA "in an effort to comment on appropriateness of detail, balance and level of understanding." Rarick suggested that elements of the label that probably would be retained include an STD warning, a discussion of efficacy in comparison with other methods, and an explanation of side effects. Rarick also suggested that the labeling should incorporate "some way to report problems." The committee unanimously voted that a toll-free telephone hotline should be established for OC users "and, ideally, for all contraceptive" users. Speakers at the Oct. 29 session included representatives of the National Women's Health Network and Family Health International. FDA intends to work with those groups as well as other organizations, Rarick said. "What we decide for oral contraceptives is going to have some kind of impact on other types of contraceptive labeling . . . including drugs and devices, over- the-counter drugs and prescription drugs," she added. "The center for drugs and the center for devices are both interested in having consistent consumer information."
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