Barr Laboratories Intends to Resubmit EC Application
Barr Laboratories has announced that it will incorporate an 18 and older age restriction into its application for emergency contraception (EC) to be made available over-the-counter to accommodate acting FDA Commissioner Andrew von Eschenbach’s request that the age limit be raised from 16.
In May 2004, Barr received a "not approvable" letter in response to its original application for EC to be available over-the-counter because of insufficient information on its use for girls younger than 16. Barr then resubmitted an application for over-the-counter access for women and girls over the age of 16, yet was denied again. In a recent letter to Barr subsidiary Duramed Research, von Eschenbach wrote that 18 is the "appropriate age" for women to access EC without a prescription, Reuters reports.
Barr CEO Bruce Downey told Reuters that he disagrees with the age restriction, noting that it will make it difficult for some women who could face an unintended pregnancy if they cannot access EC over-the-counter: "That need doesn’t discriminate on the basis of age. If you're 17 and need [EC], you need it just as quickly as someone who is 31 and needs it." Over-the-counter sales of EC have great importance because the drug is most effective taken immediately following unprotected sex, but is effective up until 120 hours.
The method by which an age restriction for over-the-counter sales would be enforced has yet to be determined. von Eschenbach requested a description of Barr’s plans to enforce the 18 and over age restriction in his letter to Duramed, writing "If after our discussion we conclude [your] program isn’t sufficiently rigorous… Plan B will remain [prescription]-only for women of all ages." Downey responded, however, that Barr cannot be held accountable for pharmacists that do not obey the restrictions.
If the FDA approves Barr's new application, the drug would be available over-the-counter within a few months.
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said Spillar. . . .