The Pill as OTC -- Access Versus Health Concerns

Pharmaceutical CommercePharmaceutical Commerce - March 2010

Some healthcare providers are pushing for OTC access to birth control. Pharma appears to be on the sideline in the debate

Since the early 1990s, debate has emerged from time to time over whether or not to make oral contraceptives available as an over-the-counter (OTC) product, to give consumers the broadest possible access to this proven method of reversible contraception, and periodically, FDA has held public hearings to discuss the issue and examine evidence offered to support both sides of the argument.


“Data from the US suggest that, at least for some women, the prescription requirement represents a barrier to both initiation and continuation of hormonal contraceptives, says Daniel Grossman, MD, FACOG, senior associate, Ibis Reproductive Health (San Francisco), and assistant clinical professor in the Dept. of Obstetrics, Gynecology and Reproductive Sciences, University of California (San Francisco). (Ibis is a nonprofit dedicated to women’s reproductive health issues worldwide.)

Grossman spearheads the Working Group on Oral Contraceptives Over-the-Counter, a multi-party stakeholder group that has been working since 1984, “to truly dissect the risks, safety, efficacy and economic impacts associated with this proposal in order to identify the critical go/no-go points drug companies and FDA would need to justify the switch to OTC,” he says.

Pro and con

Supporters argue that the obligatory medical appointment causes cost and logistical barriers to women who may otherwise benefit from this proven birth control method, and that broader access would lead to a reduction in unintended pregnancies, and thus a reduction in miscarriages, ectopic pregnancies and abortions, all of which would provide a savings to society.

Opponents say that allowing patients to sidestep the initial visit to a physician or clinician signals removes an important safety aspect of the process, which is to ensure that women are properly screened for known contraindications. Groups that promote family values and abstinence are generally against making the drugs more widely available, just as they have been against emergency contraception.

On the medical-indications question, “there’s ample evidence that women can self-diagnose for contraindications and side effects using checklists that are widely accepted by the medical community,” says Moore of RHTP. And, according to Grossman, research from Mexico (where women are able to get the pill without a doctor’s prescription) indicates that those getting it without a prior doctor’s visit were “no more likely to have contraindications to its use than women who saw a doctor.”

Says Grossman: “The prescription requirement is an out-of-date, paternalistic barrier to contraceptive use that is not evidence-based. If governments are committed to addressing the challenge of unintended pregnancy — and the related problem of maternal mortality in the developing world, health systems must create mechanisms to allow freer access to hormonal contraception for all women at low or no cost.”

Paraphrasing one of the early OTC proponents, Grossman share this observation: “If we really cared about public health, you’d need a prescription to smoke and oral contraceptives would be available in vending machines.” PC

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