From The State Column
The Obama administration is taking a tough stance on emergency contraception, according to the latest statement from Health and Human Services Secretary Kathleen Sebelius. Ms. Sebelius said Wednesday that teenagers (16 years and younger) will not be given expanded access to Plan B, despite the Food and Drug Administrationâ€™s decision to allow younger teenagers to use the morning-after pill without a prescription.
Currently, Plan B is available to women who are 17 years of age or older. However, anyone who is 16 years of age or younger needs a prescription to obtain access to Plan B. According to a FDA spokeswoman cited by The New York Times, Ms. Sebelius is the first HHS secretary to veto the agencyâ€™s decision.
â€œI reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER, and I agree with the Center that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential,â€ FDA Commissioner Margaret Hamburg said in a statement.
Ms. Hamburg received a memorandum from Ms. Sebelius Wednesday outlining the HHS secretaryâ€™s disapproval of the FDAâ€™s decision. Ms. Sebelius asked the FDA commissioner to reverse her ruling on Plan B.
â€œFDA has recommended approval of this application [from Teva Women’s Health Inc.] in its Summary Review for Regulatory Action on Plan B One-Step. After careful consideration of the FDA Summary Review, I have concluded that the data, submitted by Teva, do not conclusively establish that Plan B On-Step should be made available over the counter for all girls of reproductive age,â€ Ms. Sebelius said in a statement.
To read more, visit: Â http://www.thestatecolumn.com/health/slamming-fda-plan-b/
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