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Obama Administration Overrules FDA Approval Of Plan B – Right Wing Politics Trumps Science Again

For the first time ever, the Health and Human Services secretary – Kathleen Sebelius - has publicly overruled the Food and Drug Administration's approval of a medication. Her decision continues the policy of refusing to allow the emergency contraceptive Plan B to be sold over the counter to women under 17 without a prescription from a doctor. It overruled the FDA that was finally prepared to approve over-the-counter access to minors - a policy that is recommended by the entire scientific and medical community.

On December 7, after years of delays in approval that have kept young women under 17 from having over-the-counter access to Plan B emergency contraceptives, FDA Commissioner Margaret Hamburg, M.D. released a statement voicing FDA approval:

"I 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."

In her statement the same day rejecting Plan B and reversing the FDA decision, Sebelius tried to put a “scientific” veneer on her crudely political decision claiming that the company producing the medicine (Teva Pharmaceuticals) had not provided enough data to show that young girls of reproductive age would have the ability to use the product correctly. But this was studied for women as young as 11 years old. Also, ex-FDA administrator Susan Wood noted the hypocrisy and double standard involved in this “logic” saying that there were many drugs already available over the counter that had not been studied in pre-adolescents and that were far more dangerous to them.

“Acetaminophen can be fatal, but it’s available to everyone,” Dr. Wood noted. “So why are contraceptives singled out every single time when they’re actually far safer than what’s already out there?”

Common Sense?! For Whom? And on what basis?

President Obama, in a press conference, called this decision “common-sense”: "As the father of two daughters," he said,

"I think it is important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine."

The NYT on Dec. 7 got closer to what was really going on: "The decision avoided what could have been a bruising political battle over parental control and contraception during a presidential election."

We live in a society where today ½ of all pregnancies are unplanned, more than 40 percent of children are born to unwed mothers and 1.2 million abortions are performed every year involving one in every 50 women of reproductive age. (see “Plan to Widen Availability of Morning-After Pill is Rejected” NY Times 12/7/2011)

We live in a society with reactionary forces hounding women, especially young women and trying to control their reproduction rights and their lives. Many among the forces that oppose emergency contraception also oppose all contraception – for example the Catholic Church opposes a mandate in the medical insurance plan that private medical insurers provide women with contraceptives for free. And many others continue to promote abstinence only sex education.

The American Medical Association, the American Congress of Obstetricians and Gynecologists, and the American Academy of Pediatrics have all strongly endorsed over-the-counter access to Plan B with no age restrictions. And they have all criticized this rejection as the intrusion of politics into what should be a scientific decision. Footnote 1

The FDA's own scientists have thoroughly studied Plan B and repeatedly over a 10 year period given their approval for it's general use only to be repeatedly over-ruled. In 2005 Bush-appointee Susan Wood, then Assistant Commissioner for Women's Health and Director, Office of Women's Health at FDA resigned in protest of this same trampling by reactionary politics on science, stating:

"I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled."

Reacting to this current rejection, Wood added that the administration is

“…abandoning its scientific integrity principles, and blocking a safe and effective contraceptive”.

In 2009 A U.S. District Judge ruled that the FDA had "repeatedly and unreasonably delayed issuing a decision on Plan B for suspect reasons" and forced the FDA to lower the age to 17 and re-review the rationale for its decision.

Kirsten Moore, president of the Reproductive Health Care Technologies Project voiced what many are feeling:

"For me personally this is an incredibly disappointing moment, because I was in the East Room of the White House in March 2009 when [President Obama] signed an executive order saying this administration was committed to restoring scientific integrity to the policymaking process. And that commitment just went up in smoke today."

Footnote 1: Statements from Medical Groups

American Academy of Pediatrics

“As advocates for the health and well-being of all young people, the AAP recommends that adolescents postpone sexual activity until they are fully ready for the emotional, physical and financial consequences of sex,” said Dr. Robert Block, AAP president. “However, as physicians who care for our nation’s children, it is our responsibility to protect the health of our teenage patients, and an unintended pregnancy can have significant implications for adolescents’ physical and emotional health.”

American Society for Reproductive Medicine

The ASRM issued a statement from Dolores J. Lamb, the organization's president, that said in part: "We are very disappointed that Secretary Sebelius opted to insert herself into what should be a scientific decision made by the experts at FDA. The data are clear that emergency contraception can be safely used by adolescent women without requiring a prescription. Sadly, it appears that once again our leaders are putting political expediency ahead of reproductive health."

Society For Adolescent Health and Medicine

Added Dr. Leslie Walker, president of SAHM: “Today’s decision by the Department of Health and Human Services is a profound disappointment for the health of adolescent girls and is inconsistent with what we know about the safety and benefits of emergency contraception. Emergency contraception is a safe, effective back-up birth control method for teens and women of all ages to prevent unintended pregnancy.”