A women's health advocacy group that hopes to meet with FDA within the next year to explore potentially switching oral contraceptives to OTC may be hard-pressed to find a pharmaceutical company interested in sponsoring such a venture.
The Oral Contraceptives Over-the-Counter Working Group, coordinated by Ibis Reproductive Health, is "interested in moving oral contraceptives over the counter as a way to increase access to" the drugs, "especially for women who now face barriers to access," such as needing a prescription, said Daniel Grossman, leader of the working group and senior associate at Ibis.
"We are currently in the process of talking with a number of potential partners about what would be needed for a switch, and are hoping to meet with FDA in the next few months to discuss the regulatory pathway," said Grossman, an obstetrician-gynecologist.
One aspect the group needs to explore is finding a drug firm as a partner to sponsor a potential switch application.
Grossman said the working group is not interested in sponsoring a switch application or filing a citizen petition to switch the category.
