FDA Undermines Parents

by admin | May 6, 2013

Perhaps you have heard the buzz going around about Plan B®. On Tuesday, April 30th 2013, the FDA approved the marketing and sale of Plan B®, a potent emergency contraceptive, to girls as young as the age of 15 with no prescription required. This move of Plan B® to over-the-counter (OTC) status bothers me greatly as a Christian, as a pharmacist, and more importantly as a parent. I hope in this post to provide you with sound information to navigate this tragic downfall of medical wisdom and blatant intrusion into the parent/teen relationship brought about by the FDA’s ruling.

First off, I want to speak to you from the unique perspective of a pharmacist and bi-vocational minister. I want to put my cards on the table early, and tell you I have never sold any form emergency contraceptive to any patient under any circumstance. My conviction that life begins at conception frequently puts me at odds with many in the medical community concerning issues of life and contraception. My aim is to hold fast to my beliefs and to educate others in the truth about emergency contraception.

As I did research on the proposed mechanism of action for emergency contraceptives, such as Plan B®, I found several proposed mechanisms for preventing pregnancy. Plan B®’s website list the following possibilities:

Plan B works mainly by stopping the release of an egg from the ovary. It is possible that Plan B One-Step® may also work by preventing fertilization of an egg (the uniting of the sperm with the egg) or by preventing attachment (implantation) to the uterus (womb).

The first two proposed mechanisms are similar to the way monthly oral contraceptives work, but it is the last possibility that prevents me from selling the product. The manufacturer says that this drug may prevent the implantation of an already fertilized and viable embryo into the uterus wall thereby causing the body to abort this viable life. Now I am not saying that in every case of emergency contraception use prevention of implantation is the only mechanism possible, but I am saying that in every case of use, it is possible. In most of the literature on emergency contraceptive, this mechanism is downplayed or ignored all together. To allow young girls access to such a drug without this vital information clearly violates the patient’s right to informed consent.

Another problem I have with the approval of the over-the-counter sale of Plan B® is the FDA appears to be setting a double standard. Levonorgestrel, the active ingredient found in Plan B®, is allowed this privileged OTC status only in emergency contraceptive product formulations such as Plan B® or Next Choice®. Levonorgestrel, found in 19 other formulations for routine monthly oral contraception, is still available only by prescription under the supervision of physicians and pharmacists. This prescription-only status stresses that the FDA believes monthly use of Levonorgestrel is best managed by doctors who can perform annual health screenings, such as pap smears, to rule out sexually-transmitted diseases and cervical cancer. With Plan B now available to teens with no screening or medical care, we are not promoting women’s health but in reality suppressing much needed care to some of our youngest patients. Two separate studies performed in both the U.K. and the U.S. have found that STD rates increase as much as 12% with OTC access to emergency contraceptives such as Plan B®. Without screenings and education, we are putting women at risk.

Finally, emergency contraceptives are not intended as primary means of contraception as Plan B®’s own website declares. Allowing unlimited, unsupervised use of emergency contraceptives will lead to overuse. I have seen this in my own practice as women come in time and time again for an emergency contraceptive that states on the packaging is not intended to be used as a primary means of contraception. Allowing Plan B® OTC to girls as young as 15 will further send the message that emergency contraception is a primary option for continual use. This exposes young girls to repeated high doses of Levonorgestrel leading to common side effects like: nausea, vomiting, fatigue, dizziness, lower abdominal pain, and menstrual irregularities. In fact each dose of Plan B One-Step® contains as much Levonorgestrel as 15 days of monthly oral contraceptives that require a prescription from a doctor. These high doses of hormones are not safe as primary means for contraception, and access to such drugs should be overseen by appropriate healthcare providers.

As a Doctor of Pharmacy looking at the debate over OTC availability to emergency contraceptives for teenage girls, I am baffled at the decision of the FDA last week. This decision will lead to overuse of high potency emergency contraceptives and reduce doctor/patient encounters for proper health screenings. This decision is a step backwards for women’s health.

Looking at this debate as the father of a little girl, I am outraged that the FDA would undermine parent’s involvement in the lives of their children. As parents, we have every right to be involved in all decisions concerning our children’s health. Now teenage girls are faced with enormous health decisions apart from parental involvement and without physician guidance. This is unacceptable!! Our children deserve better than this!!

The FDA granting OTC status of emergency contraceptives to girls age 15 and older should be a wake-up call to us all. Where we have opportunity, we need to speak out against foolish policies that are infringing upon our rights as parents, endangering the lives of our children, and most of all, taking the lives of the innocent. We must be vigilant in teaching our children to navigate such issues with godly wisdom. We should pray for God to change the hearts and minds of those in office making laws and judgments. The FDA ruling is stimulating conversations, and the truth will always triumph. I leave you with this from Galatians 6:9, “Let us not become weary in doing good, for at the proper time we will reap a harvest if we do not give up.