Thrown under the Bus, FDA overruled by HHS

by Sophia Yen MD MPH, Board certified in Adolescent Medicine, Board certified in Pediatrics

When they overruled the FDA decision to send Emergency Contraception(EC) over the counter (OTC), last Wednesday, the Obama administration threw women, science, and birth control under the bus.

Some have said that failing to get EC for those 16 and under is no big deal because it affects so few, and that EC fails a lot.

Sure EC can fail, but what about the successes? Those people go on with their lives and don’t show up in the MDs office. We also see EC failure b/c of the delay in access — the longer it takes to get the med, the less likely it is to work. Allowing over the counter access results in earlier use and thus more likelihood for the medication to work.

Also, it is the principle of the matter – it is UNPRECEDENTED for the HHS to overrule the FDA. Who is Sebelius to override the nonpartisan FDA panel who reviewed the case? Who is she to overrule all the MDs from the AMA, ACOG, AAP, SAHM and health providers/researchers from 30+ other medical organizations that have supported EC over the counter with NO age limit? Did she go to medical school? Does she see patients daily? Has she reviewed all the science regarding EC and adolescents? — the FDA panel did, the AMA, ACOG, AAP, SAHM did. (click here for AAP.ACOG.SAHM statement condemning the HHS action) This ruling is a slap in the face to the entire medical and scientific community.

As a board certified pediatrician and board certified adolescent medicine specialist, I see the results of what happens when teenagers don’t have access to birth control – they get pregnant! and then you have unwanted pregnancies, ruined futures, and/or abortions. Are those American values – unwanted pregnancies and unnecessary abortions?

This was purely a political play, ignoring science, using anecdotal qualms reminiscent of the Bush days to counter science. President Obama and Sec. Sebelius were throwing out red herrings when they stated they had concerns about 11 year olds. What about the 15-16 year olds?

There is NO harm from an 11 year old taking this medicine. There IS harm from overdosing on acetaminophen, ibuprofen or taking aspirin with a viral illness in children but these meds are all over the counter. Why is this medication being treated any differently? POLITICS

Shame on President Obama for invoking his 2 daughters as justification. I invoke my 2 daughters and say, I will talk to my daughters about the dangers of over the counter medications like acetaminophen, ibuprofen, etc and I hope that he will talk to his.

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Some great reference documents about EC and Adolescents

Excerpts from statements by major medical organizations about EC and Over The Counter access for adolescents (at the bottom of the page) by Advocates for Youth.

2008 brief on EC by the Bixby Center covering