Tuesday, 25 November 2014 / TRUTH-OUT.ORG

Sebelius Overrules FDA Decision to Widen Access to Morning-After Pill

Wednesday, 07 December 2011 08:29 By Jodi Jacobson, RH Reality Check | Report
Sebelius Overrules FDA Decision to Widen Access to Morning-After Pill

Kathleen Sebelius, the secretary of health and human services, at a briefing at the Health and Human Services Department in Washington, on May 27, 2010.  (Photo: Luke Sharrett / The New York Times)

In what can only be called an astounding move by an Administration that pledged on inauguration day that medical and health decisions would be based on fact not ideology and for which women are a major constituency, today Kathleen Sebelius, Secretary of the Department of Health and Human Services (HHS) overruled a much-awaited decision by the U.S. Food and Drug Administration (FDA) to make emergency contraception (EC) available over-the-counter (OTC) to women of all ages.

According to the New York Times, "no health secretary has ever [overruled an FDA decision] before."

EC has been available over-the-counter for women ages 18 and older for at least two years.  The FDA has been further reviewing data on whether the method should be available OTC without a prescription to those age 17 and younger at risk from unprotected intercourse.

In a statement this afternoon FDA underscored that it "had been carefully evaluating for over a decade whether emergency contraceptives containing levonorgestrel, such as Plan B One-Step, are safe and effective for nonprescription use to reduce the chance of pregnancy after unprotected sexual intercourse."

Experts, noted the statement, "including obstetrician/gynecologists and pediatricians, reviewed the totality of the data and agreed that it met the regulatory standard for a nonprescription drug and that Plan B One-Step should be approved for all females of child-bearing potential."

"I reviewed and thoughtfully considered the data, clinical information, and analysis provided by the Center for Drug Evaluation and Research (CDER)," wrote Dr. Margaret Hamburg, head of the FDA and author of the statement, "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."

However, she wrote:

[T]this morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential. Because of her disagreement with FDA’s determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved.  Following Secretary Sebelius’s direction, FDA sent the complete response letter to Teva today.  Plan B One-Step will remain on the market and will remain available for all ages, but a prescription will continue to be required for females under the age of 17.

Why?

I have one word. P.O.L.I.T.I.C.S.

If we have been reminded of one thing in the past several months, it is that politicians and religious leaders alike will, when it suits them, marginalize the rights and needs of women to advance their own interests and need for power. And somewhere, someone in the Obama Administration, perhaps the president himself, gave the cue to HHS to overrule the FDA decision. And clearly, as she sometimes did as governor of Kansas, Sebelius did the deed.

Because apparently the health and rights of women do not matter, but placating the far right does. Because apparently helping teens actually prevent unintended pregnancies isn't an authentic a goal of this administration. Perhaps it was among the topics on which President Obama came to "understand the concerns of Catholics [read the 281 bishops]," as Archbishop Timothy Dolan assured the New York Times after his private meeting with the president.

Because the evidence is indisputably in favor of the FDA's decision

CDER reviewed all the evidence on use of EC by younger women. It's findings?

CDER carefully considered whether younger females were able to understand how to use Plan B One-Step.  Based on the information submitted to the agency, CDER determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.  [Emphasis added.]

But no amount of proof it seems can make up for the fact that, despite all the evidence, even President Obama and Secretary Sebelius appear to think young women are too stupid to make their own decisions or that they are just chum to be thrown to the religious right in an election year.

As the saying goes, with friends like these, who needs the far right?

Jodi Jacobson

Jodi Jacobson is Editor-in-Chief of RH Reality Check.


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Sebelius Overrules FDA Decision to Widen Access to Morning-After Pill

Wednesday, 07 December 2011 08:29 By Jodi Jacobson, RH Reality Check | Report
Sebelius Overrules FDA Decision to Widen Access to Morning-After Pill

Kathleen Sebelius, the secretary of health and human services, at a briefing at the Health and Human Services Department in Washington, on May 27, 2010.  (Photo: Luke Sharrett / The New York Times)

In what can only be called an astounding move by an Administration that pledged on inauguration day that medical and health decisions would be based on fact not ideology and for which women are a major constituency, today Kathleen Sebelius, Secretary of the Department of Health and Human Services (HHS) overruled a much-awaited decision by the U.S. Food and Drug Administration (FDA) to make emergency contraception (EC) available over-the-counter (OTC) to women of all ages.

According to the New York Times, "no health secretary has ever [overruled an FDA decision] before."

EC has been available over-the-counter for women ages 18 and older for at least two years.  The FDA has been further reviewing data on whether the method should be available OTC without a prescription to those age 17 and younger at risk from unprotected intercourse.

In a statement this afternoon FDA underscored that it "had been carefully evaluating for over a decade whether emergency contraceptives containing levonorgestrel, such as Plan B One-Step, are safe and effective for nonprescription use to reduce the chance of pregnancy after unprotected sexual intercourse."

Experts, noted the statement, "including obstetrician/gynecologists and pediatricians, reviewed the totality of the data and agreed that it met the regulatory standard for a nonprescription drug and that Plan B One-Step should be approved for all females of child-bearing potential."

"I reviewed and thoughtfully considered the data, clinical information, and analysis provided by the Center for Drug Evaluation and Research (CDER)," wrote Dr. Margaret Hamburg, head of the FDA and author of the statement, "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."

However, she wrote:

[T]this morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential. Because of her disagreement with FDA’s determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved.  Following Secretary Sebelius’s direction, FDA sent the complete response letter to Teva today.  Plan B One-Step will remain on the market and will remain available for all ages, but a prescription will continue to be required for females under the age of 17.

Why?

I have one word. P.O.L.I.T.I.C.S.

If we have been reminded of one thing in the past several months, it is that politicians and religious leaders alike will, when it suits them, marginalize the rights and needs of women to advance their own interests and need for power. And somewhere, someone in the Obama Administration, perhaps the president himself, gave the cue to HHS to overrule the FDA decision. And clearly, as she sometimes did as governor of Kansas, Sebelius did the deed.

Because apparently the health and rights of women do not matter, but placating the far right does. Because apparently helping teens actually prevent unintended pregnancies isn't an authentic a goal of this administration. Perhaps it was among the topics on which President Obama came to "understand the concerns of Catholics [read the 281 bishops]," as Archbishop Timothy Dolan assured the New York Times after his private meeting with the president.

Because the evidence is indisputably in favor of the FDA's decision

CDER reviewed all the evidence on use of EC by younger women. It's findings?

CDER carefully considered whether younger females were able to understand how to use Plan B One-Step.  Based on the information submitted to the agency, CDER determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.  [Emphasis added.]

But no amount of proof it seems can make up for the fact that, despite all the evidence, even President Obama and Secretary Sebelius appear to think young women are too stupid to make their own decisions or that they are just chum to be thrown to the religious right in an election year.

As the saying goes, with friends like these, who needs the far right?

Jodi Jacobson

Jodi Jacobson is Editor-in-Chief of RH Reality Check.


Hide Comments

blog comments powered by Disqus