Barr Pharmaceuticals, Inc. reported that the US Food and Drug Administration (FDA) has approved the Supplemental New Drug Application (sNDA) filed by Barr's wholly-owned subsidiary, Duramed Pharmaceuticals, Inc., to market the Plan B (levonorgestrel) emergency contraceptive Over-The-Counter (OTC) without a prescription. In approving the sNDA, FDA granted OTC status for consumers 18 years of age and older, while maintaining the prescription status for women 17 and younger.
The company's Plan B OTC product and the prescription product will be marketed as a single package, which will allow for a prescription label to be adhered to the package when dispensed to women age 17 and younger. Because Plan B will still remain a prescription product for women 17 and younger, it will be sold in retail pharmacy outlets from behind the counter. Duramed plans to introduce the dual status Rx/OTC version of the product before the end of the calendar year, a Barr press release stated.
As part of the Plan B OTC approval, the company has reached an agreement with FDA on its CARE(SM) (Convenient Access, Responsible Education) Programme that supports efforts to ensure that Plan B is used responsibly and appropriately. The CARE programme is designed to limit the availability of Plan B only to pharmacies and clinics with professional healthcare supervision, to educate healthcare professionals and consumers within the target age groups regarding the availability and responsible use of Plan B, and to monitor the effectiveness of the programme. In addition, the company intends to work closely with retail pharmacies and drug wholesalers to ensure that they understand and follow the FDA's prescription age requirement for the dispensing of the product.
"While we still feel that Plan B should be available to a broader age group without a prescription, we are pleased that the Agency has determined that Plan B is safe and effective for use by those 18 years of age and older as an over-the-counter product," said Bruce L Downey, Barr's chairman and CEO. "Although Plan B will continue to be available to all women of child- bearing age, we believe making Plan B available without a prescription to those 18 and older will ensure that millions of women have more timely access to an emergency oral contraceptive following unprotected sexual intercourse or a contraceptive failure. We intend to work with healthcare providers, pharmacists and patients to educate them about the availability of this product. We will also continue our efforts with the FDA to reduce the age restriction on the OTC use of Plan B."
Taken within 72 hours of unprotected intercourse, Plan B has been shown to reduce the risk of pregnancy by 89 per cent after a single act of unprotected sex. Effectiveness declines as the interval between intercourse and the start of treatment increases. Plan B is more effective when taken in the first 24 hours after intercourse. The decline in efficacy from a delay in treatment is why a broad range of health professionals believes that barriers to more timely access to Plan B should be removed, including making the product broadly available without prescription.
There are nearly three million unintended pregnancies each year in the United States. Unintended pregnancy is a major public health issue, affecting women in all reproductive age groups and socio-economic backgrounds. Plan B has been well-studied and shown to reduce the pregnancy rate, after a single incident of unprotected intercourse, from 8 per cent to 1 per cent, an 89 per cent reduction. Plan B should not be used as routine contraception and does not protect against HIV/AIDS and sexually transmitted diseases (STDs).
Emergency contraception is currently available through pharmacy access programs in some pharmacies in nine US states (Alaska, California, Hawaii, Maine, Massachusetts, New Hampshire, New Mexico, Vermont and Washington).
Progestin-only contraceptive pills (POPs) are used as a routine method of birth control over longer periods of time, and are contraindicated in some conditions. It is not known whether these same conditions apply to the Plan B regimen consisting of the emergency use of two progestin pills. POPs are not recommended for use in the following conditions: known or suspected pregnancy; hypersensitivity to any component of the product; and, undiagnosed abnormal genital bleeding.