ORAL CONTRACEPTIVE LABELING CHANGE ALLOWING DEFERRAL OF PHYSICIAN EXAM

Executive Summary

ORAL CONTRACEPTIVE LABELING CHANGE ALLOWING DEFERRAL OF PHYSICIAN EXAM at a patient's request was recommended by FDA's Fertility & Maternal Health Drugs Advisory Committee at its May 20 meeting. The committee voted nine-to-one in favor of the labeling changes proposed by the Planned Parenthood Federation of America. "The committee concurs with the recommendations of [Planned Parenthood]," Committee Chairman Ezra Davidson, MD, Charles Drew Postgraduate Medical School of Los Angeles, said. The recommendation agreed to by the committee states that oral contraceptive labeling be changed to read: "physical examination before initiation of oral contraceptives may be deferred if requested by the patient and judged appropriate by the physician." The advisory committee's recommendation, if adopted by FDA, could eliminate one of the obstacles to an Rx-to-OTC switch for oral contraceptives. FDA indicated its interest in such a switch earlier this year when it announced plans to bring the issue before the Fertility & Maternal Health Drugs Advisory Committee in February. Although FDA later canceled that meeting, FDAers have said that the issue still is alive at the agency and a joint meeting of FDA's OTC Drug advisory committee and Fertility & Maternal Health committee may still be scheduled by the end of the year ("The Tan Sheet" March 29, p. 3). Current oral contraceptive labeling states that a medical history review and physical exam, which includes a pelvic exam and cervical cytology, "should be taken prior to initiation or reinstitution of oral contraceptives and at least annually during use of oral contraceptives." While certain aspects of the physical exam, such as blood tests and Pap smear, could be delayed several months, the committee suggested that labeling encourage that "guidelines similar to those approved by Planned Parenthood Federation of America are used and annual history and physical examinations are recommended." Planned Parenthood guidelines specify that women being prescribed oral contraceptives should: receive a medical history review; have no contraindications to oral contraceptives; report no symptoms of sexually transmitted diseases; receive a blood pressure test; undergo a pregnancy test; receive a breast exam for women 30 years and older; complete the informed consent process; and receive instruction regarding oral contraceptive and condom use. Planned Parenthood Federation of America VP Medical Affairs Michael Policar, MD, explained to the committee that the group requested the labeling change "because of concerns regarding adequacy of access to OCs [oral contraceptives] and the wide- spread perception that many young sexually active women avoid seeking OCs because of the fear of pelvic examination and blood tests." The committee agreed that the prescribing of oral contraceptives should not be tied to the requirement of a pelvic exam, which is used to detect sexually transmitted diseases and cervical cancer. "It is not really necessary to know what the [outcome of the] patient's Pap smear is to give her birth control pills," committee member Jennifer Niebyl, MD, University of Iowa, commented. The committee based its decision in part on information from the Family Planning Council of Philadelphia's "Smart Start" program in which young women using public services were allowed to defer their physical exams up to six months while being prescribed oral contraceptives. About 23% of the women elected to delay their pelvic exams, with 78% of those returning within six months to have a complete physical exam. There were no increases in serious STDs or previously undiagnosed disease upon follow-up of the women who delayed pelvic exams compared to women who had pelvic exams at initiation of oral contraceptives. Committee member Nancy Lee, MD, Centers for Disease Control and Prevention, remarked that while the "Smart Start" data were encouraging, the committee is "not making this decision on the basis of one small study in a select subpopulation, but we are making it on the basis of an enormous amount of information that says this is a safe drug." The committee urged that any delay in receiving a physical examination should be no more than several months. Planned Parenthood currently recommends that women receiving oral contraceptives receive a pelvic exam within six months of starting on the Pill. One opponent of the label change, National Latina Health Organization Director Luz Alvarez Martinez, told the committee that "if the label is changed, the message is being given that medical exams and Pap smears are not necessary." She maintained that her group sees this as "the first step toward an over-the- counter birth control pill." Martinez added: "We have many concerns about that, and I know I will have an opportunity to voice those concerns in upcoming meetings." Martinez was one of several leaders of women's health groups that met with FDA Commissioner David Kessler in March to discuss several general contraceptive issues, including a possible Rx-to-OTC switch of oral contraceptives. One of the groups' concerns is that OTC availability could reduce the accessibility to oral contraceptives for poorer women because OCs would no longer be reimbursed.