Skip to main content

FDA Approves Over-the-Counter Access for Plan B for Women 18 and Older

FDA News FOR IMMEDIATE RELEASE
August 24, 2006
Consumer Inquiries: 888-INFO-FDA

FDA Approves Over-the-Counter Access for Plan B for Women 18 and Older
Prescription Remains Required for Those 17 and Under

The U.S. Food and Drug Administration (FDA) today announced approval of Plan B, a contraceptive drug, as an over-the-counter (OTC) option for women aged 18 and older. Plan B is often referred to as emergency contraception or the "morning after pill." It contains an ingredient used in prescription birth control pills--only in the case of Plan B, each pill contains a higher dose and the product has a different dosing regimen. Like other birth control pills, Plan B has been available to all women as a prescription drug. When used as directed, Plan B effectively and safely prevents pregnancy. Plan B will remain available as a prescription-only product for women age 17 and under.

Duramed, a subsidiary of Barr Pharmaceuticals, will make Plan B available with a rigorous labeling, packaging, education, distribution and monitoring program. In the CARE (Convenient Access, Responsible Education) program Duramed commits to:

*Provide consumers and healthcare professionals with labeling and education about the appropriate use of prescription and OTC Plan B, including an informational toll-free number for questions about Plan B;

*Ensure that distribution of Plan B will only be through licensed drug wholesalers, retail operations with pharmacy services, and clinics with licensed healthcare practitioners, and not through convenience stores or other retail outlets where it could be made available to younger women without a prescription;

*Packaging designed to hold both OTC and prescription Plan B. Plan B will be stocked by pharmacies behind the counter because it cannot be dispensed without a prescription or proof of age; and

*Monitor the effectiveness of the age restriction and the safe distribution of OTC Plan B to consumers 18 and above and prescription Plan B to women under 18.

Today's action concludes an extensive process that included obtaining expert advice from a joint meeting of two FDA advisory committees and providing an opportunity for public comment on issues regarding the scientific and policy questions associated with the application to switch Plan B to OTC use. Duramed's application raised novel issues regarding simultaneously marketing both prescription and non-prescription Plan B for emergency contraception, but for different populations, in a single package.

The agency remains committed to a careful and rigorous scientific process for resolving novel issues in order to fulfill its responsibility to protect the health of all Americans.

####

Popular posts from this blog

Texas State Affairs Committee hears testimony on two adoption bills

On March 27, 2017, Ms. Cochran-Green testified before the Texas Senate State Affairs Committee on two adoption-related bills, SB 329 and
SB 1362.  You can watch the live testimony here. Ms. Cochran-Green's testimony is the Part 1 of the State Affairs Meeting on March 27.  Her testimony is in the second hour and she testified separately on each bill.

SB1362 is authored by Sen. Campbell in which she proposes changes to the voluntary adoption registry.  Ms. Cochran-Green testified her opposition to the bill as much of the proposed bill is already codified in the Texas Family Code and is common practice among adoption agencies.

SB329 is authored by Senator Creighton in which he proposes to allow adult adopted persons to obtain their original birth certificates at the age of 18.  Ms. Cochran-Green supports this bill as it allows adopted persons in closed adoptions primarily from the 1930s-1990s to seek reunions with their birth parents and obtain medical history that is needed.  This…

Mother's Day: A Time for Reflection and Celebration

This is the time of year that we celebrate motherhood, not only the day-to-day life of being a mom, but also the journey itself.  For some, infertility challenges that journey.  Thankfully there are more options than ever for those who want to become a mother. For many, like myself, the solution was adoption.  I am so thankful for the miracle of adoption, but is it right for you?  The following questions may help you find your answer.
Are you emotionally prepared for adoption? As with making any family planning decision, adoption requires a lot of self-reflection. It also requires that you come to terms with any grief you are experiencing resulting from infertility issues. A friend who adopted told me that she decided to adopt because the chances of becoming a parent were much higher than IVF. That’s true, but there are other challenges to consider. Open adoption is now the norm and it is recommended by experts in the field. Consequently, birth parents will become a part of your famil…

Documents Every Graduating Senior and College Student Needs

Now that high school graduation is upon us, it’s a time for celebration and reflection for parents and students alike. For parents, you now face the fact that your little bird is leaving the nest.  Is he or she ready? Legally, they are adults now and entitled to privacy protections. This means that even though your child may be relying on your financial support, privacy laws prohibit financial institutions, medical providers and colleges from disclosing private information concerning your child unless authorized. In case of an emergency, your child needs the following documents in place for you to be able to help them and make decisions on their behalf:
  1. Durable Power of Attorney: This document allows you to manage their financial affairs (either immediately or in the future) should they travel abroad or become mentally or physically unable to do so. This includes managing their financial accounts,  renewing their car registration, or filing a tax return on their behalf.
  2. Medica…