FDA Backs Off New Birth-Control Guidelines

This week, the U.S. Food and Drug Administration’s Reproductive Health Drugs Advisory Committee held a two-day meeting to discuss, among other items, the possibility of implementing new standards of effectiveness for hormonal contraceptives. However, while the panel encouraged drug manufacturers to conduct post-market studies to determine the products’ safety, they stopped short of setting new guidelines with regard to their efficacy.

The major hurdle facing the FDA is finding a balance between safety and efficiency. Newer contraceptives have been shown to carry with them fewer side effects, but have also proven to be, in some cases, half as effective in preventing pregnancies as their older counterparts. Panelists decided that consumers should be offered a range of treatment options, and therefore, they are reluctant to recommend any hard-and-fast guidelines in terms of effectiveness.

The agency issued an odd statement earlier this week, defending the newer drugs against charges of ineffectiveness. “Recent wire service stories about today’s meeting of the FDA Reproductive Health Drugs Advisory Committee have created misperceptions about the effectiveness of newer generation hormonal contraceptives. The stories inaccurately report that the products are significantly less effective at preventing pregnancy than those approved decades ago. In fact, the newer generation products are highly effective in preventing pregnancy.”

However, the FDA’s briefing document, released ahead of the meeting, referred in several spots to the relative ineffectiveness of the newer drugs, stating: “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].”

The FDA’s statement also disputed the claim that the meeting was called to “discuss the need for higher standards of efficacy for the newer products.” However, the briefing document clearly states that one of the main agenda items was discussion of “contraceptive efficacy and risk/benefit assessment.”

Possible discussion items listed in the briefing document include, “Is there a pregnancy rate that would be unacceptably high, regardless of the risk/benefit balance of the product? If so, what would that rate be?” They also ask, “Should we accept a possible decrease in effectiveness balanced by an even less well documented decrease in the risk of serious adverse events with lower dose products as compared to higher dose products?” In another section, they pose the question: “How should divergent pregnancy rates, obtained in U.S. and non-U.S. populations, be considered in the approval process and in labeling?”

While the panel did call for voluntary post-market safety studies to be conducted by drug manufacturers, it is highly unlikely that the companies will do so at their own cost. In short, it appears that the FDA has let Big Pharma off the hook again.

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