Teva Opposes Switching Asthma Drugs, Oral Contraceptives
This article was originally published in The Tan Sheet
The firm’s opposition to allowing innovative switches for asthma drugs and oral contraceptives focuses on safety and consumers’ ability to self-select and manage their allergies or reproductive status, but maintains that Plan B One-Step and other emergency contraceptives are appropriate for full OTC status.
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A new paradigm for nonprescription approvals could eliminate the risk of self-selecting a birth control drug, with some contraindications might likely not apparent, by having pharmacists provide counseling and screening or having women use a self-assessment tool with a standard algorithm.
FDA considers switching some prescription “antidotes” to restricted nonprescription status so consumers who can self-identify their need for the drugs and who previously had a prescription can easily access them during life-threatening events, says CDER Director Janet Woodcock.
HHS Secretary Sebelius says Teva must show more evidence of how young adolescent females would use Plan B One-Step as an OTC. But obtaining such clinical data for the emergency contraceptive – in excess of what FDA already needed to approve it – appears nearly impossible, experts say.