FDA makes morning after pill more accessible to teenage girls - Tucson Local Media: News

FDA makes morning after pill more accessible to teenage girls

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Posted: Wednesday, May 1, 2013 11:53 am | Updated: 12:01 pm, Wed May 1, 2013.

The Food and Drug Administration (FDA) is making it easier for teenage girls to get over-the-counter birth control, by allowing Plan B One-Step emergency contraceptive to be sold without a prescription to women 15 years of age and older.

The FDA announced Thursday that it approved an amended application submitted by Teva Women’s Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use.

After the FDA did not approve Teva’s application to make Plan B One-Step available over-the-counter for all females of reproductive age in December 2011, the company submitted an amended application to make the product available for women 15 years of age and older without a prescription.

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.

Plan B One-Step is an emergency contraceptive intended to reduce the possibility of pregnancy following unprotected sexual intercourse – if another form of birth control (e.g., condom) was not used or failed. Plan B One-Step is a single-dose pill (1.5 mg tablet) that is most effective in decreasing the possibility of unwanted pregnancy if taken immediately or within 3 days after unprotected sexual intercourse.

Plan B One-Step will not stop a pregnancy when a woman is already pregnant, and there is no medical evidence that the product will harm a developing fetus.

“Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States,” said FDA Commissioner Margaret A. Hamburg, M.D. “The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease.”

The approval of Plan B One-Step for use without a prescription by women 15 years of age and older is based on an actual use study and label comprehension data submitted by Teva showing that women age 15 and older understood that the product was not for routine use and would not protect them against sexually-transmitted diseases. These data also established that Plan B One-Step could be used properly within this age group without the intervention of a health care provider.

Because the product will not protect a woman from HIV or AIDS or other sexually-transmitted diseases, it is important that young women who are sexually active remember to see a health care provider for routine checkups. The health care provider should counsel the patient about, and if necessary test her for, sexually-transmitted diseases, discuss effective methods of routine birth control, and answer any other questions the patient may have.

Teva has indicated that it plans to educate consumers, pharmacy staff, and health care professionals about the product’s new status. It has also indicated its willingness to conduct an audit of the age verification practices after the product is approved to ensure that the age limitation is being followed.

On April 5, 2013, a federal judge in New York ordered the FDA to grant a 2001 citizen’s petition to the agency that sought to allow over-the-counter access to Plan B (a two dose levonorgestrel product) for women of all ages and/or make Plan B One-Step available without age or point of sale restrictions. However, Teva’s application to market Plan B One-Step for women 15 and older was pending with the agency prior to the ruling.

The FDA’s approval of Teva’s current application for Plan B One-Step is independent of that litigation and this decision is not intended to address the judge’s ruling.

The Department of Justice is considering next steps in the litigation. In the meantime, the FDA took independent action to approve the pending application on Plan B One-Step for use without a prescription by women 15 years of age or older.

There are currently three emergency contraceptive drugs marketed in the United States – Plan B One-Step, Plan B, and ella. Plan B, available from generic manufacturers, uses two doses of levonorgestrel (.75 mg in each tablet), taken 12 hours apart, and requires a prescription for women under the age of 17. Ella (ulipristal) is a prescription-only product that prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected sexual intercourse. The approval of Teva’s application for Plan B One-Step does not affect the prescription status of these other drugs.

Teva Women’s Health is based in North Wales, Pa.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Welcome to the discussion.

1 comment:

  • John Flanagan posted at 7:50 pm on Wed, May 1, 2013.

    John Flanagan Posts: 341

    Disturbing, but typical of what is to be expected at this time in our history, when the progressives in charge of government know what is best. Parents need not worry about preaching chastity to their daughters, after all, when they reach 15 years old, the government will give them access to birth control, as well as an abortion, if need be. And the 15 year old girls already sexually active can simply get some extra pills to dispense to their 13 and 14 year old friends.
    Mom and Dad need not know, so a contemporary progressive version of "don't ask, don't tell" automatically goes into affect. Of course, the 15 year old sexually active young lady who becomes intimate with the 18 year old football jock in her high school could involve the guy in criminal charges, because the legal system would consider the relationship one of statutory rape. No mention of that, or of any concern to Sebellius the abortion industry's trusted chief bureaucrat,nor Obama, the political champion of government sponsored health care....that is except for unborn children made in God's image. Unless the child is wanted, the only health care available is abortion, the final solution in this grisly inhumane business.
    I suppose some might believe the Democrats have a superior and more enlightened view of sexuality, and as such, this new ruling affirms their idea that we must leave any semblance of a Christian moral foundation behind as we set off into this new century. Hollywood, by insisting on reducing most ethical and moral values, and scoundrel politicians who reflect this hip philosophy of life, will continue to erode the soul of America until liberalism achieves the goal of finally constructing a pagan wasteland.

     

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