Non-Prescription Access for Minors to Plan B Pill Denied by FDA

. 12/07/2011 . 1 Comment

The Food and Drug Administration refused to change distribution for Plan B One-Step to an easily available over-the-counter product which would no longer require a prescription. A measure was on the table which would make the emergency contraception available to females aged 16 and younger. Conservative religious groups fought the measure and insisted that the drug not be sold without involvement of parents. Fears were also expressed that putting the Plan B drug on the shelves of retail stores would encourage child abuse and sexual activity amongst minor children.

The FDA Commissioner Margaret A. Hamburg, M.D. released the following statement this morning:

“I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER, and I agree with the Center that 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, this morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential. Because of her disagreement with FDA’s determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved. Following Secretary Sebelius’s direction, FDA sent the complete response letter to the pill’s maker, Teva Pharmaceutical Industries Ltd, today. Plan B One-Step will remain on the market and will remain available for all ages, but a prescription will continue to be required for females under the age of 17.”

I think this decision by Health and Human Services Secretary Kathleen Sebelius is a huge mistake. Her decision will do nothing but keep very young females of child-bearing age under the control of pedophiles and those with an agenda to force females to bear children they do not want to have.

She claims that there is no evidence that the young women would understand the risks and how to use the pill without talking to a doctor first. Hogwash!

Pharmacists are always available to answer questions about any other the counter or prescription drug sold in the store in which they work. Information could have been included in the product packaging that was written for a person of only sixth grade reading level to understand. There are school staff, websites, and staff at free clinics available to answer any question a girl might have. Those with health insurance can call their health plan’s advice nurse as well.


To me there is no excuse not to put Plan B on the shelves for easy access by every female that wants to prevent a possible pregnancy.

As I connect the dots, I believe this decision is short-sighted and eyebrow-raising. Consider the fact that the FDA quickly approved Gardasil to be used in females as young as nine years old to prevent a sexually transmitted disease. Nine, ten and 11 year old girls are not supposed to be having sex, so why should they need such an inoculation. Yet, the FDA will not approve a product for use by teens to prevent an unwanted pregnancy. Sounds to me like the FDA is in cahoots with pedophiles of America that want the girls they molest to be healthy enough to have the babies of their rapists.

Black nationalists, in no way considered to be “conservative groups,” also believe that Plan B, birth control and Planned Parenthood were created to exterminate Black children. Both groups are out of their minds.

The chief concern I have is that people that decide to be parents have the means to take care of those children properly. That means you are fully there emotionally, mentally, and financially to support that child’s growth and development into a productive human being. Our role as parents is to help our children shine, to protect their innocence and spirits, and to educate them in every way possible about the world and the people in it.

Now, if a person is on drugs, broke, stupid, confused, mentally ill, emotionally damaged, or an unemployed minor child, they do not have the ability or resources to care for and raise a child. In that instance birth control, Plan B or abortion is the best option.

Refusal to allow young girls the option to have access to Plan B in instances of sexual assault, sexual coercion or is a travesty. Plan B will not make children become victims of a predator, as that is happening millions of times per year already. What such a change in distribution would have done is allow young women the opportunity to protect their future by preventing an unwanted pregnancy. Statistically, the children born to teens have a higher likelihood of becoming victims of a sexual predator, on drugs themselves, or in foster care – which is a direct pipeline to the nation’s prisons.

Now, knowing these facts, how can Planned Parenthood (key emphasis on PLANNED) or Plan B emergency contraception for all females be a bad thing?

What is wrong with young women having the option to protect themselves so that they can have a child when mentally and emotionally mature enough to handle the responsibility?

What do you say?

Deborrah

Veteran social researcher, relationship advice columnist, author and radio host. Author of hundreds of articles on American and black culture, gender issues, singles, dating and relationships. Author of "Sucka Free Love!" , "The 24 Types of Suckas to Avoid," "The Black Church - Where Women Pray and Men Pray," and "Why Vegan is the New Black" all available on Amazon.Com. Her unique voice and insightful commentary have delighted fans and riled haters for 20 years. Read her stuff on SurvivingDating.Com and AskHeartBeat.Com.

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