FDA Set to Reevaluate Contraceptive Pills

This week, the U.S. Food and Drug Administration’s Reproductive Health Drugs Advisory Committee is meeting to discuss the efficacy and safety of hormonal contraceptive products. According to an FDA briefing document about the general meeting, government scientists are concerned that newer versions of the birth-control pill are not as effective at preventing pregnancy as older treatments were. Failure rates among some newer contraceptives are roughly double that of the older drugs.

The meeting will focus on oral, transdermal, and vaginal contraceptive products only. The FDA hopes to establish clear guidelines regarding clinical trials for hormonal contraceptives. Among the topics to be discussed at this week’s meeting: clinical trial design issues, contraceptive efficacy and risk/benefit assessment, cycle control (scheduled and unscheduled bleeding and spotting), translation of clinical trial findings of efficacy and safety into “real world” effectiveness and safety, extended dosing regimens, and the role and impact of labeling in communicating product efficacy, risk, and other benefits.

One major concern is the fact that, according to the FDA, “pregnancy rates in clinical trials … in support of approval for new contraceptive products appear to have increased through the years, particularly in the past decade.” The FDA believes that this may be attributable to the fact that lower dosages of estrogens and progestins are being used.

“The risk/benefit assessment of hormonal contraceptives has historically tried to balance not only the safety and efficacy demonstrated in the clinical trials but also the safety implications of an unplanned pregnancy,” notes the FDA’s document. “Therefore, the serious adverse events related to thrombosis and thromboembolic complications need to be balanced against similar risks associated with an unplanned pregnancy, including the postpartum period. The primary clinical trials used to support approval of all oral contraceptives from 1960 to 1970 had contraceptive failure rates of [less than 1 per 100 women per year].

“The Division [of Reproductive and Urologic Products] has observed that as the dosage of the estrogen and progestin components have decreased to that seen in products contemporarily being presented to the Agency, the number of method failures has increased; this is consistent with less sustained ovulation suppression in newer products. In the past decade, some oral contraceptive products have been approved with overall [failure rates] above [two per 100 per year].”

Panelists will discuss whether or not to establish a maximum rate of failure for all approved contraceptives.

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