“This action by a government entity flies in the face of responsible medical practice and concerns for women’s health,” Barron said, adding that “claims that the benefits of this action outweigh the risks are unfounded, especially in light of strong evidence of the many harmful risks of hormonal contraception to women’s health.”
Opill, a progestin (synthetic hormone)-based drug produced by Perrigo, is the first over-the-counter oral contraceptive to receive FDA approval. Under the FDA’s new guidelines, individuals can obtain and use Opill without the guidance or supervision of a doctor.
The drug’s approval is likely to lead to increased use of contraceptives. With Opill set to be easily accessible and available in retail drugstores in early 2024, it is expected to be heavily used by young women, even minors.
According to Perrigo, Opill is safe for all ages, so long as menstruation has begun. However, the AP reported the FDA had concerns about flaws in Perrigo’s research and testing. Nevertheless, the FDA announced Opill had received official approval on July 13. There is no age restriction on Opill’s use.
The U.S. bishops have long advocated against FDA nonprescription approval of Opill because of potential harmful side effects. When the FDA was still considering the matter in May, Barron strongly urged the administration to reject Perrigo’s Opill approval request.
“Fertility is a gift, not a disease. Contraceptives exist to suppress the healthy functions of human reproduction,” Barron said in a May statement.
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