Wednesday, December 07, 2011

Obama's War On Reproductive Rights

President Barack Obama signed an executive order strengthening the federal restrictions on federal funding for abortions. The Hyde amendment already prohibited federal funds for abortions. The Obama administration went one step further in restricting reproductive rights. HHS Secretary Kathleen Sebelius overruled the FDA on the morning after pill.

NARAL sent out a press release.


NEW YORK—Today the FDA announced the Secretary of Health and Human Services – for the first time ever – has invoked her authority to overrule the agency’s decision to approve the emergency contraceptive pill Plan B One-Step for full over-the-counter sale, which would have removed what was widely recognized to be a politically motivated age restriction on its access. This is the first time in history the Health Secretary has ever used this power to overrule an FDA decision. Had the FDA decision gone into effect, women of all ages would have been able to purchase this back-up birth control method without a prescription and without delays at the pharmacy counter.

“This is a deeply disappointing betrayal from an Administration that had pledged to promote the health and well-being of women and families and be guided by science and medicine,” said Andrea Miller, President of NARAL Pro-Choice New York. “The evidence is clear, the FDA has done more than its due diligence, and women across the nation deserve ready access to a safe, effective second chance to prevent an unintended pregnancy. The decision to overrule the FDA is reminiscent of a troubling era, when the Bush Administration routinely allowed politics to trump science, especially in its interference with the FDA’s deliberations over this product.”

The FDA first approved Plan B as a prescription product in 1999. Seven years later, in 2006, the FDA approved over-the-counter access to Plan B for those eighteen and older – an age restriction later deemed by the Government Accountability Office and federal courts to be politically, not scientifically, motivated. In response, the age restriction on the over-the-counter product was lowered to seventeen the following year.


Does the Obama political team think that the Tea Party and the Christian Right (which is one and the same) is suddenly going to vote for Democrats because of restrictions on Plan B? This is a political decision that does nothing to win the mythical middle.

Obama apologists will defend this as part of the President's 3D chess game with Republicans. The debt ceiling disaster proves that Obama isn't that politically astute. What we do know by Obama's actions is that he is not passionate about protecting the reproductive rights of women. People can write commentary about how Obama actually cares about women. These same people will ignore Obama's actions on reproductive rights. Tell a woman after she has been sexually violated that the reason she can't get the the Plan B pill is because Obama cares. I dare you to try it. I will be suprised if the woman doesn't slap you in the face.

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Monday, March 30, 2009

Good News For Reproductive Rights

U.S. District Court for the Eastern District of New York rejected the Bush administrations policy of allowing Plan B to be only over-the-counter. Judge Edward R. Korman found the FDA went against medical opinion to form policy.


The FDA considered the Citizen Petition in tandem with a number of proposals –referred to as supplemental new drug applications (“SNDA”) – submitted by Women’s Capital Corporation, the drug’s original manufacturer. Women’s Capital Corporation sold its right to market Plan B to Barr Pharmaceuticals, Inc. during the course of the proceedings described below. I refer to them collectively as the “Plan B sponsor.” The first SNDA, like the Citizen Petition, sought non-prescription access to Plan B for women of all ages. After the FDA denied such access, the Plan B sponsor submitted a second SNDA, seeking non-prescription access for women 16 and older. The FDA rejected that application too despite nearly uniform agreement among FDA scientific review staff that women of all ages could use Plan B without a prescription safely and effectively. The Plan B sponsor then submitted a third SNDA, which proposed making Plan B available without a prescription to women 17 and older. While FDA scientists and senior officials found that 17 year olds could use Plan B safely without a prescription, the FDA Commissioner determined that, because of “enforcement” concerns, Plan B would be available without a prescription only to women 18 and older. Putting aside for the moment the specifics of the many claims brought by plaintiffs and the details of each of the FDA’s decisions, the gravamen of plaintiffs’ claims is that the FDA’s decisions regarding Plan B – on the Citizen Petition and the SNDAs – were arbitrary and capricious because they were not the result of reasoned and good faith agency decision-making.

Plaintiffs are right. The FDA repeatedly and unreasonably delayed issuing a decision on Plan B for suspect reasons and, on two occasions, only took action on Plan B to facilitate confirmation of Acting FDA Commissioners, whose confirmation hearings had been held up due to these repeated delays. The first occasion involved the confirmation of then-Acting FDA Commissioner Lester M. Crawford, who froze the review process for seven months in 2005. In order to overcome a hold that had been placed on his nomination by two Senators, the Secretary of Health and Human Services promised that the FDA would act on Plan B by September 2005. After Dr. Crawford was confirmed by the Senate in July 2005, however, he reneged on the promise and, instead, delayed action another eleven months to pursue, and then abandon, a rulemaking with respect to Plan B. There is also evidence that when the FDA finally decided to approve non-prescription use of Plan B for women 18 and older, it did so to facilitate the confirmation of Commissioner Crawford’s successor, then-Acting FDA Commissioner Andrew C. von Eschenbach, whose confirmation certain Senators had vowed to block because of the continued delays on Plan B.

These political considerations, delays, and implausible justifications for decision-making are not the only evidence of a lack of good faith and reasoned agency decision-making. Indeed, the record is clear that the FDA’s course of conduct regarding Plan B departed in significant ways from the agency’s normal procedures regarding similar applications to switch a drug product from prescription to non-prescription use, referred to as a “switch application” or an “over-the-counter switch.” For example, FDA upper management, including the Commissioner, wrested control over the decision-making on Plan B from staff that normally would issue the
final decision on an over-the-counter switch application; the FDA’s denial of non-prescription access without age restriction went against the recommendation of a committee of experts it had empanelled to advise it on Plan B; and the Commissioner – at the behest of political actors – decided to deny non-prescription access to women 16 and younger before FDA scientific review staff had completed their reviews.



The one thead that runs through every Bush cabinet department is putting politics over sound policy. The Obama administration is taking the first step to rescend a Department of Health and Human Services policy that would allow health care providers not to perform abortion. Bush used religious freedom as a cover. The Catholic church was successful in having the Nicaraguan government make abortion illegal. The result has been dead women. The sanctity of life apparently doesn't cover pregnant women.

The HHS rule ‘‘Ensuring that Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law’’ can cut off funding to any health care facility that forces a doctor or nurse to perform an abortion or sterilization. I have not read one news story of a health care worker forced to perform these medical procedures. I do remember a Hillsborough County jail preventing a rape victim from taking a second doze of Plan B. The victim reported being raped and the Tampa Police Department arrested her for owing $4,585 restitution. At least the jail worker was able to practice her religious freedom.

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