Where In Law or the Constitution is This?

How does a judge think that he can make himself the FDA? Just because he likes the morning after pill, he thinks he can make it available to children without a doctor’s or nurse practitioner’s oversight. The FDA is an imperfect but scientific organization which bases its decisions mostly on the science and also takes into account cultural, economic, and political factors that impact the functioning of that science in the real world. I personally hated that they made the so called emergency contraceptive available, but the problem is with the Congress that did not set as policy the personhood of the unborn.  By the science, it is relatively safe for adult women over 16 to take.  It is not the job of the FDA to make law.  It made a reasonable decision to make it available. I never questioned the FDA on that because I trust them to make decisions based upon the science. The same FDA was much more cautious on the idea of giving high hormone doses to children without medical supervision.  The biggest problem with making the drug OTC is that some 14 year old girl could use it instead of controlled birth control dosages or condoms.  She could be fed them once a week by her 20 year old boy friend who wants to cover his tracks.  This could lead to cancer later in life.  The FDA is safeguarding children because there is no science validating the long term effect of unregulated use on children.  Will the judge be held responsible?  No.  He has no responsibility that is why he legally has no authority.  If he wants it, he should resign and apply for the FDA.  That is the way the system works.  Edward Korman should be reminded of that.  He ceased to be a federal judge yesterday and became a policy maker.

6 thoughts on “Where In Law or the Constitution is This?”

  1. I agree, major overreach of judicial authority. I don’t know the medical science behind all of the effects and side effects of the morning after pill on the human body, but I am aware that medications can have far greater impact on bodies that have not yet fully matured. I don’t think the judge is an expert on the medical science either.

    My question is, are there any other medications that require a prescription for children, but not adults? I know a lot of medications you can buy over the counter state in the indications that parents should consult a doctor before they give it to children under a specific age. Are their similar situations with prescription drugs?

  2. Judge Korman’s decision is, in fact, supported by the FDA’s, “Center for Drug Evaluation and Research (CDER) experts, including obstetrician/gynecologists and pediatricians, who 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.”

    The CDER finding was over-ruled by Secretary of Health and Human Services, Kathleen Sibelius, who has no medical work experience or eduction.

    http://www.prnewswire.com/news-releases/statement-from-fda-commissioner-margaret-hamburg-md-on-plan-b-one-step-135184603.html

  3. In that case, as with most of President Obama’s appointees, it makes me wonder why she has the position in the first place. If she is so under qualified and is making choices that are so clearly wrong, why was she granted such a position of authority at the head of HHS?

    Now as to the ruling. From a libertarian standpoint I supposed you could see a significant silver lining if Plan – B, no longer being a prescription medication, is not on the list of medications paid for by our tax dollars. That would mean one less thing that taxpayers will have to foot the bill for, and one less form of birth control/abortion that people opposed to it for religious reasons would have to pay for with their tax dollars.

  4. This judge finally said enough is enough… Time to stop listening to wannabe conservatives representing only 11% of the population… I like how he said 30 days… make it happen in thirty days…

    Finally sanity when it comes to sex… sheesh…. what is a matter with conservatives, anyways? If you want to make babies, do it in your house… Don’t make teenage girls have to make them for you…

  5. Korman was a Reagan appointee, and worked at the DOJ (Appellate Section) under Bork. The decision was, essentially, a rebuke of the Omaba administration, Sebelius in particular.

    From WSJ:

    …The Food and Drug Administration actually was preparing to allow over-the-counter sale of Plan B One-Step with no age limits in late 2011 when Health and Human Services Secretary Kathleen Sebelius, in an unprecedented move, overruled her own scientists. Sebelius said some girls as young as 11 are physically capable of bearing children but shouldn’t be able to buy the pregnancy-preventing pill on their own.

    The federal judge dismissed that argument.

    “This case is not about the potential misuse of Plan B by 11-year-olds,” said Korman, who called the pills safe for girls but said the number using them “is likely to be minuscule” as less than 3 percent of girls under age 13 are sexually active.

    He cited the Administrative Procedure Act as granting a judge the authority to set aside an agency’s rulings “if they are ‘arbitrary, capricious, an abuse of discretion or otherwise not in accordance with law.'”

    Korman said regulation requires that when the FDA allows nonprescription drug sales, “the standards are the same for aspirin and for contraceptives” — and he ultimately determined that the government violated those standards in the case of Plan B.

    “The decision that the agency was forced to make, contrary to its own policies and judgment, is not entitled to any deference,” Korman concluded. “Indeed, it is hardly clear that the secretary had the power to issue the order, and if she did have that authority, her decision was arbitrary, capricious, and unreasonable.”

    It was the judge’s latest ruling in a lawsuit filed by the Center for Reproductive Rights and dating back to 2005 that pushed for unfettered over-the-counter access to Plan B…

    “More than twelve years have passed since the citizen petition was filed and eight years since this lawsuit commenced,” Korman wrote in a decision dated Thursday and released Friday. “The FDA has engaged in intolerable delays in processing the petition. Indeed, it could accurately be described as an administrative agency filibuster.”

    The judge said the FDA decided after 11 months, 47,000 public comments and hundreds of thousands, if not millions, of dollars spent, that it did not need rulemaking on the subject.

    “The plaintiffs should not be forced to endure, nor should the agency’s misconduct be rewarded by, an exercise that permits the FDA to engage in further delay and obstruction,” he wrote.

    Four years ago, Korman was highly critical of the Bush administration’s initial handling of the issue when he ordered the FDA to let 17-year-olds obtain the medication, instead of setting the age at 18. At the time, he accused the government of letting “political considerations, delays and implausible justifications for decision-making” cloud the approval process.

    If a woman already is pregnant, the pill has no effect. It prevents ovulation or fertilization of an egg. According to the medical definition, pregnancy doesn’t begin until a fertilized egg implants itself into the wall of the uterus. Still, some critics say Plan B is the equivalent of an abortion pill because it may also be able to prevent a fertilized egg from attaching to the uterus, a contention that many scientists — and Korman, in his ruling — said has been discredited.

    The question isn’t about the pill so much as Sebilius’ altering an FDA decision for political reasons rather than for scientific reasons.

  6. Once again, the judge has no legal authority to substitute his policy judgement for DHHS. It is a perfectly reasonable position to understand that 11 to 14 year olds are not women and frequent use of this drug by them has never been studied by the government. K. S. Was right. As I said, you have to take into account cultural reality. Now 14, 15 and even 13 year old girls will be exploited. But at least a profit will be made.

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