Teva Pharmaceuticals, the manufacturer of Plan B (the “morning after pill”), submitted a request to the FDA to make the pills available over the counter (OTC) without any age restrictions. That would effectively have paved the way for emergency contraceptives to be sold on store shelves, instead of from behind the pharmacy counter. Today, as expected, FDA scientists recommended that Teva Pharmaceuticals’ request be approved. However, Health Secretary Kathleen Sebelius overruled their recommendation and declined to remove the restrictions.
History of Plan B and the FDA
In 2003, the FDA went against a committee recommendation to make the drug available OTC. According to Jessica Valenti, “they were worried about young women getting all slutty”. She also quoted one of the FDA committee members who said: “What we heard today was frequently about individuals who did not want to take responsibility for their actions and wanted a medication to relieve those consequences.”
Eventually, in 2006, the FDA agreed to make Plan B available without a prescription, but age restrictions on access to it (only for those 17 or over) effectively meant that women had to talk to a pharmacist to get it and that those under 17 had to see a doctor to get a prescription first.
Today’s Overruled Recommendation
This year, Teva Pharmaceuticals applied to have the age restrictions removed, which would have allowed Plan B to be sold on drugstore shelves, right between the condoms and the pregnancy tests. Today, FDA Commissioner Margaret Hamburg, M.D. released a statement noting that teenage girls were able to use Plan B effectively without help. She wrote:
The Center for Drug Evaluation and Research (CDER) completed its review of the Plan B One-Step application and laid out its scientific determination. CDER carefully considered whether younger females were able to understand how to use Plan B One-Step. Based on the information submitted to the agency, CDER determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.
In conclusion, she said:
There is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.
However, Dr. Hamburg then noted that she received a memorandum from Secretary Sebelius indicating that she did not agree with the Agency’s decision and that she was invoking her authority to block the approval.
The Arguments For and Against Making Plan B More Accessible
As with any issue relating to birth control and reproductive rights, there are countless arguments both for and against it. According to Valenti, the key arguments made by conservatives who oppose OTC sales of Plan B include:
- It kills babies
- It will make girls more promiscuous
- It will make girls more vulnerable to predators
- It will prevent parents from knowing what their kids are up to
Valenti breaks down each of those arguments, explaining why they are wrong and then goes on to explain the reasons why making Plan B available OTC would be “an important milestone in reproductive health access”:
- It would remove the age restriction that currently makes Plan B inaccessible to those who need it most.
- It would cut out the pharmacist middleman, who may judge women and girls asking for it and attempt to insert themselves in their decisions.
- It has been proven to be safe method of reducing unwanted pregnancies.
When I was 17, my best friend had recently become sexually active with her boyfriend of over a year. They were using condoms, but one night the condom broke. We worked together at the same summer job and after she got off the bus at work the next morning, she told me what had happened. She ended up having to fake an illness and I had to request permission leave work as well to drive her to the doctor to get a prescription and then to the pharmacy to pick up the Plan B. The whole elaborate scheme could have been prevented if she and her boyfriend had been able to stop quickly at the drug store on the drive back to her place the night before.
That is just one example. I’ve heard of other women requesting Plan B because their husband or boyfriend was abusive and they didn’t want to bring a child into a relationship like that. I’ve heard of women who were raped and didn’t want to have the rapist’s baby. I’ve heard of women who would have a difficult time getting out of school or work to go to a doctor’s appointment, but who could easily stop at a drugstore. These are all women who are potential candidates for later getting an abortion or bringing an unwanted baby into the world. Plan B is an effective way to avoid either of those scenarios.
Essentially, the veiled attempts to “protect” women by restricting access to Plan B is, in reality, a way of controlling them, curtailing their freedom, and inconveniencing them for something that they did with (at best) or was done to them by a man.
The Canadian Experience
Plan B has been available OTC in all Canadian provinces except Quebec since 2008. In theory, that is. In practice, people’s experiences are mixed. In Ottawa and Toronto (both in Ontario), it appears to still be behind the counter, but easily accessible if you ask a pharmacist. However, out West it can be purchased openly on store shelves. Some people, both in Ontario and out West reported seeing empty Plan B boxes on the shelf that read “talk to the pharmacist”. In Quebec, where there are still restrictions, Plan B can be obtained by speaking with the pharmacist (no prescription is required). It seems that even with the removal of restrictions in Canada, it may be up to the owners of each pharmacy to decide how they want to handle the sale of Plan B.
The Result: No Change
As a result of Secretary Sebelius’ decision to overrule Dr. Hamburg and the FDA scientists, the current rules regarding access to Plan B will remain in place. All women will be able to access Plan B, but it will remain behind the counter and females under the age of 17 will still need a prescription. Planned Parenthood reacted to the decision by saying that “The FDA’s decision today will no doubt prevent thousands of women and teens from being able to prevent unintended pregnancies.”
Photo credit: meddygarnet on flickr