FDA Drops Access Restrictions On Generic OTC Emergency Contraceptives
This article was originally published in The Tan Sheet
In a recent letter to drug firms, FDA rejects Plan B One-Step manufacturer Teva’s requests to restrict sales and labeling of generic equivalents. Labeling for the generics will not prevent consumers under 17 from buying the products nor require retailers to ask consumers for proof of age.
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The Center for Reproductive Rights and other plaintiffs suing FDA say the agency’s plan to approve only Teva’s Plan B One-Step for universal OTC sales, but not less-expensive generic emergency contraceptives, would not provide sufficient access for all women.
The Reproductive Health Technologies Project, plus 45 other organizations and 18 professionals, urge HHS Secretary Kathleen Sebelius to revisit her decision to overrule full OTC availability of Teva’s Plan B One-Step emergency contraceptive.
A federal judge seems inclined to order FDA to make emergency contraceptives available OTC to women younger than 17, but he did not say whether the use would be limited to Teva’s Plan B One-Step, or would include all nonprescription levonorgestrel products.