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ORAL CONTRACEPTIVE USE BY 18.7 MIL. WOMEN IN 1992 MARKS 2.5% INCREASE

Executive Summary

ORAL CONTRACEPTIVE USE BY 18.7 MIL. WOMEN IN 1992 MARKS 2.5% INCREASE in users for the year, numbers from the 1992 Ortho Annual Birth Control Study show. In 1991, 16.8 mil. women ages 15 to 50 (or 25.4% of the total population of 66.2 mil. in that cohort) used oral contraceptives. In 1992, 27.9% of the 66.8 mil. women of childbearing age used OCs. Ortho noted that the birth control pill "remains the nation's most popular contraceptive" and is "at its highest recorded usage level in the 24-year history" of the Ortho survey. Ortho surveyed 7,900 women in April and extrapolated the results to the U.S. population. The Ortho contraceptive survey is being released to coincide with a direct-to-consumer ad campaign for Ortho's Ortho-Novum 7/7/7 oral contraceptives. A two-page print ad will run in the October issues of Glamour, Mademoiselle, Self, Vogue, Health and People. The first ads will appear Sept. 15, Ortho said. Ortho is turning to the consumer campaign as prescriptions for Ortho-Novum 7/7/7 are declining. According to Pharmaceutical Data Services data released in March, Ortho-Novum 7/7/7 prescriptions dropped by 3.1% to 11.4 mil. in 1991. According to PDS, that decline was part of a general trend among OCs for the year. PDS data indicate that prescriptions for OCs were down by 2.7 mil. in 1991 ("The Pink Sheet" March 16, p. 9). Described by Ortho as "the first ever broad-scale national advertising campaign to feature a branded oral contraceptive," the ad features the tag-line: "We've come full circle since 1960" and a picture of 28 Ortho-Novum pills arranged in a circle. The ad was created by DDB Needham Worldwide. Generic OCs have been advertised to consumers before. In March 1989, ads for a generic product from Lexis ran in several magazines, touting the product's 50% price advantage compared to the innovator products, Ortho-Novum 1/35 and Syntex' Norinyl 1 + 35. The Ortho ad copy emphasizes "added health benefits" associated with oral contraceptives. "There is evidence that Pills such as Ortho-Novum 7/7/7 may provide some protection against developing ovarian cancer and cancer of the lining of the uterus. In addition, the Pill may decrease the incidence of acute Pelvic Inflammatory Disease...Iron-deficiency anemia and ectopic pregnancies may also occur less frequently with Pills like Ortho- Novum 7/7/7," the ad reads. The use of the phrase "Pills such as Ortho-Novum 7/7/7" may reflect an FDA warning issued to oral contraceptive manufacturers in June 1991. In a letter addressing unsupported comparative claims for OCs, FDA noted that a direct-to-consumer ad policy is under development and advised that "in the interim...the appropriate promotion to consumers should be that of non-product specific advertisements which might also encourage women to discuss their contraceptive choices with a health care provider" ("The Pink Sheet" June 24, 1991, T&G-1). The emphasis on "other health benefits" of oral contraceptives may be intended to expand the appeal of the products to older women. The advertising copy specifically states that "healthy, non- smoking women can stay on the Pill beyond age 40 as long as there is a need for contraception and providing there's no medical reason to discontinue use." Ortho described that line as an attempt to counter the "misconception...that healthy, non- smoking women cannot remain on the Pill past the age of 35." The Ortho survey indicates that more older women are using oral contraceptives. "The percentage of Pill users 35-to-39 years of age has tripled within the last five years," Ortho said. "An even more dramatic finding is that five years ago, only 2% of all women between the ages of 40 and 44 were on the Pill; this year, 10% of these women actively use the method." Other findings from the survey include a .5% use rate for Wyeth-Ayerst's implantable contraceptive Norplant. That represents about 330,000 users. According to the survey, Norplant is chosen by 4% of new users of contraception. Oral contraceptives, meanwhile, are the choice of 43% of new users of contraception.

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