Plan B becoming available to girls of all ages was a huge victory for contraception availability advocates. However, lifting the age restrictions for Teva s Plan B One-Step has had an impact on the availability of the generic forms of the emergency contraception.
After the government dropped its fight to keep the medicine age-restricted, the Food and Drug Administration (FDA) went on with its original plan to allow Plan B One-Step to be available without age restrictions. The FDA also granted Teva an additional three years as the exclusive seller of this product.
The implications of this are somewhat complicated. While Teva's Plan B One-Step has been approved for all ages, the generic versions of the drug have not yet been approved. Because there is no longer a prescription version of Plan B One-Step, since it is now fully over-the-counter for all ages, its generic counterpart will also no longer be available through prescription. However, the generic versions are not approved for all ages by the FDA due to the fact that the FDA just granted exclusivity to Teva. This means that anyone under the age of 17 will be unable to access the medicine until 2016 when generic versions are eligible to apply to the FDA for all-age accessibility.
Plan B One-Step costs about $50, and will be available in the pharmacy with no restrictions. The generic one-pill product, which is less expensive, will be available on shelves but only to those who are 17 and older. This, unfortunately, may limit access to the contraception for younger girls with financial restrictions.
The two-pill version of the medicine is significantly cheaper, and will still be available for those 17 and older with proof-of-age, and for anyone under 17 with a presciption.
ACSH s Dr. Ruth Kava adds, It is important for girls of all ages to have access to emergency contraception, but making the medicine affordable is equally as important. It is unfortunate that access to one-step versions of the contraception will be limited as a byproduct of a complicated policymaking process.