A federal judge has recently ordered the FDA to start selling the morning after pill (or emergency contraception) to women 16 years old and younger and without parental consent.
There’s a case for parental consent for Plan B, but the GOP isn’t making it. Instead of focusing on the scientific and medical issues surrounding it, they are too busy shouting about abortion.
First, the left is de facto making the case to change the age of consent across the country by demanding Plan B be made available without parental consent. One would think offering Plan B over-the-counter without parental permission directly enables violations of state consent laws.
Parents deserve to be treated as parents, not meddling features for the state to supersede at all times.
The second point can be made by the simple act of pulling up the U.S. Prescribing information and discovering a few obvious facts.
- In Clinical Trials, the mean age of women given Plan B One-Step was 27 years.
- This product is not intended for use in the premenarcheal population, and pharmacokinetic data are not available for this population.
- Pediatric Population guidance is for any person under 18.
So what does this mean?
It means there are no controlled studies of this product in women under 18. That means the dose, safety profile, and efficacy are not proven. In layman’s terms, it means there is no basis to determine how much to give, whether it would work for the intended purpose, or what side effects may occur.
Children experience hormone fluctuations that are very different than those of a full grown adult. For a hormone-based product, it’s surprising that there wasn’t a requirement to study it in pediatric populations if it was eventually going to be prescribed to them. The current label provided by the manufacturer reflects an indication population (mean age 27) for which there is no scientific evidence to suggest parallel safety and efficacy profiles with the new intended age group (under 17s).
This is understandable in one sense. It is very hard to conduct pediatric trials, because parents are reluctant to give consent to participate in a drug trial that has unknown effects or risks for their child. This is often the case for many drugs, so there is precedence to use drugs approved for adults in pediatric populations precisely because of this challenge. Likewise, to study the use of Plan B in a clinical trial would require parental consent since a child has been determined to not be capable of providing consent.
It’s a reasonable position to advocate for continued parental consent for a product that remains untested in girls 16 and younger.
In fact, a quite scientifically defensible one.
The left is again ignoring science and advocating to prescribe an untested medication in children without parental consent. Regardless of your politics, this is wrong for parents and children. Yet the GOP has thus far, chosen to treat this as an abortion issue leaving room for the left to proclaim it is another example of the broader “war on women.”
Read the Label for yourself
Those are the Facts. The GOP should use them wisely.