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.
8/28/2015 Alaska Court Protects Abortion Access for Low-Income Women - The Alaska Superior Court struck down a state law yesterday that would have severely limited abortion access for low-income women in Alaska.
The state's Superior Court also struck down a Department of Health and Social Services regulation that placed narrow specifications on Medicaid coverage for abortions, requiring that Medicaid-funded abortions be determined by a physician to be "medically necessary." Last year, the Center for Reproductive Rights, the American Civil Liberties Union, and Planned Parenthood sued on behalf of the Planned Parenthood of the Great Northwest, claiming that the narrow definition of "medically necessary" arbitrarily established conditions designed to restrict the ability of low-income women to access abortion services.
The law was temporarily blocked last July by an Alaskan state court judge.
Superior Court Judge John Suddock ordered yesterday that the state be blocked from implementing this regulation, ruling that it placed an undue burden on low-income women seeking abortion services in Alaska.
"By providing health care to all poor Alaskans except women who need abortions, the challenged regulation violates the state constitutional guarantee of 'equal rights, opportunities, and protection under the law'," the ruling read.
"We applaud the superior court for striing down these cruel restrictions on women's health and rights that violate the Alaska Constitution," said Chris Charbonneau, CEO of Planned Parenthood of the Great Northwest and the Hawaiian Islands. . . .
8/26/2015 Saudi Women Prepare to Vote for the First Time - The fight for gender equality is making slow but notable progress in Saudi Arabia, where women will be allowed to vote for the first time in upcoming December elections.
This shift in Saudi law came in 2011, when a royal decree announced that women would be allowed to vote and run in local elections beginning in December of 2015. . . .