Should Birth Control Get a Fast Track Through the FDA?

As much as we would love over-the-counter pills, here's an argument for why we should treat birth control like any other drug.
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Food and Drug Administration Commissioner Margaret Hamburg speaking at the White House in 2011. (Photo: Alex Wong/Getty Images)

Food and Drug Administration Commissioner Margaret Hamburg speaking at the White House in 2011. (Photo: Alex Wong/Getty Images)

There's a growing push in the United States right now to make hormonal birth control available over the counter. But we have to make sure to implement such policies in a way that follows existing law-making paths, even if that's slightly slower, argues a new report by the Guttmacher Institute, a group that studies and advocates for family-planning policies.

Progressive women's and doctors' groups have long advocated for over-the-counter birth control; studies suggest pills, patches, and rings can be offered safely without a prescription, and polls show women would be interested in that option. What makes this recent movement unique is who's joining the effort: socially conservative Republican lawmakers. Instead of creating a bipartisan movement, however, the arrival of the newcomers has stirred up controversy with their proposals. One important question under debate: Does the Food and Drug Administration need a nudge?

One of social conservatives' best-known efforts to support over-the-counter birth control is the Allowing Greater Access to Safe and Effective Contraception Act, proposed in May by two Republican senators from New Hampshire. The act requires the FDA to give any applications to make hormonal birth control over-the-counter priority review. It also waives the FDA application fee.

Hormonal birth control should go through the FDA process just like any other drug.

But it's better science and policy to let hormonal birth control undergo the same FDA review process that any drug would, former FDA Assistant Commissioner Susan Wood argues in the Guttmacher Institute report. "We have to ensure that women's health products are treated as routinely as other drugs," Wood writes. "Special privileges such as fast track status and fee waivers set up a structure founded on an assertion that reproductive health products are different and require interventions—such as age requirements—when they're not necessary." (The Allowing Greater Access to Safe and Effective Contraception Act would still require girls under the age of 18 to get a prescription for hormonal birth control, which Wood says is not medically justified. Age cutoffs create undue trouble for some of the most vulnerable girls and women, as Pacific Standard previously reported.)

Wood's argument recalls the recent controversy over flibanserin, the "female Viagra," whose FDA approval some feminist groups lobbied for. The FDA rejected flibanserin twice, citing its side effects. While the drug is now approved, debate still rages over whether it should have ever earned approval, especially after in-depth reporting revealed how the pro-approval lobbying group was funded by the company that owned flibanserin at the time, Sprout Pharmaceuticals.

Do medicines for women deserve priority consideration by the FDA? It depends on whether you think agencies like the FDA unfairly de-prioritize drugs for women. Research has indeed shown that FDA-approved drugs that are later recalled tend to have harsher side effects for women, perhaps because drugs designed for both men and women are unfairly tested on more men and male lab animals. But we're not aware of any research showing that the FDA approval process for drugs, which evaluates already-conducted studies on drugs' safety and effectiveness, is biased against drugs for women. The process has made serious mistakes before, but it is the best we have to ensure drugs are safe and effective. We shouldn't ask for shortcuts around it because we suspect bias; we need to first ask for hard evidence of bias. Lacking that, hormonal birth control should go through the process just like any other drug.

We're sure Wood would agree. She's famous for resigning from the FDA when the agency delayed making Plan B available over the counter.

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