Today, in a proposal that can best be described as adding insult to injury, the Food and Drug Administration (FDA) approved making emergency contraception (EC) available over-the-counter for teens and women ages 15 and up. This convoluted proposal from the Obama administration comes despite a court order in early April by U.S. District Court Judge Edward R. Korman to make EC available over-the-counter to all ages within 30 days of his decision. It comes from an administration which pledged to make science the cornerstone of public policy and instead has consistently flouted a wealth of accumulated evidence on emergency contraception. It also comes after several studies showing that current policy requiring prescriptions for some groups and not others has confused so many pharmacists that access to EC has been denied to many who were in fact legally eligible to obtain it quickly. In practice, the new policy will almost certainly perpetuate, not resolve, that confusion.
The battle to make EC available over-the-counter has gone on for over a decade and spanned both the Bush and Obama administrations. Judge Korman’s ruling was issued in response to the Center for Reproductive Rights’ (CRR) renewed lawsuit against the FDA seeking to expand over-the-counter access for all women to all brands of the morning-after pill, including Plan B One-Step and Next Choice. The most recent CRR lawsuit was filed after Kathleen Sebelius, secretary of the Department of Health and Human Services, overruled a 2011 FDA decision to make emergency contraception available over-the-counter to all ages, underscoring that the Obama administration, like its predecessor, has difficulties dealing with the realities of sex and pregnancy prevention.
The administration’s newest plan is to make EC available over-the-counter to individuals ages 15 and up, but still require prescriptions for those under age 15. While pharmacies can stock it in the family planning section of main store shelves, people seeking to buy EC will have to show identification with a birth date to a cashier. The plan comes after approval this week by the FDA of an amended application submitted by Teva, the manufacturer of Plan B One-Step, to allow OTC sale to those ages 15 and over, after an earlier request to do so had been denied by FDA in December 2011. The amended application was in any case superceded by the scientific evidence that led the FDA to rule in 2011 on making emergency contraception available OTC to all ages, the decision that was, as noted above, subsequently overturned by Sebelius. So in using the approved Teva application as the reason for this newest decision, the FDA is essentially reversing itself and ignoring the science on which its 2011 decision was based. Confused yet? Me too. It’s a complete circus, and I have no doubt that leadership at the FDA, which tried to make evidence-based policy in 2011, came under pressure from the White House to find the “fix” it announced today.
According to the FDA press release:
The product will now be labeled “not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified.” Plan B One-Step will be packaged with a product code prompting a cashier to request and verify the customer’s age. A customer who cannot provide age verification will not be able to purchase the product. In addition, Teva has arranged to have a security tag placed on all product cartons to prevent theft.
In addition, Teva will make the product available in retail outlets with an onsite pharmacy, where it generally, will be available in the family planning or female health aisles. The product will be available for sale during the retailer’s normal operating hours whether the pharmacy is open or not.
NPR reported that “the FDA said … Plan B One-Step will be packaged with a product code that prompts the cashier to verify a customer’s age. Anyone who can’t provide such proof as a driver’s license, birth certificate or passport wouldn’t be allowed to complete the purchase. In most states, driver’s licenses, the most common form of identification, are issued at age 16.”
There are several serious problems with this approach, apart from the fact that it ignores scientific and medical findings that call unequivocally for over-the-counter access for all.
First, the policy is not in compliance with the court ruling and therefore may in fact be thrown out. The Department of Justice will have to bring it before Judge Korman for approval and potentially seek a stay of his ruling altogether, throwing EC once again back to the courts.
Second, it still requires a prescription for a subset of the population potentially in need of EC, and therefore creates a significant barrier, especially for low-income teens under 15 years of age or those without ID who “look” younger and are denied access. Emergency contraception is for emergencies. It prevents unintended pregnancy by preventing ovulation, and is therefore most effective when taken within 72 hours of unprotected intercourse (including in cases when another contraceptive method may have failed). The need to see a physician to obtain a prescription that the public health and medical communities have deemed unnecessary is both time-consuming and expensive, and will entail additional indirect costs in terms of loss of time at school and work, likely on the part of both teens and their parents. This requirement serves the interests of no one except anti-choice opponents of birth control, and those in the Obama administration who still seem unable or unwilling to think beyond their own fears of teens and sex, or to go beyond personalizing policy to accommodate their own paternalistic fears of their daughters as sexual beings.
Third, language, lack of identification, and other potential barriers will remain an obstacle for many communities. Many 15- and 16-year-olds do not have IDs that display birth dates, and those who are well above the age limit but “look younger” to a clerk will be required to produce identification, documentation that many people in this country still do not have readily available or that, in a hurry, some might not remember to bring with them to the store.