Tag: Food and Drug Administration

Obama’s War On Women Goes To Court

Cross posted from The Stars Hollow Gazette

The latest shot in the war on women by the Obama administration goes to court. A federal court judge in Brooklyn, NY will hear challenge by the Center for Reproductive Rights to the constitutionality of Health and Human Services Secretary Kathleen Sebelius’ veto of the Federal Food and Drug Administrations decision to make the “morning after” pill. Plan B, available without a prescription thus making it accessible to teen age girls under the age of seventeen.

The Center for Reproductive Rights and other groups have argued that contraceptives are being held to a different and non-scientific standard than other drugs and that politics has played a role in decision making. Social conservatives have said the pill is tantamount to abortion.

Judge Edward Korman was highly critical of the government’s handling of the issue when he ordered the FDA two years ago to let 17-year-olds obtain the medication. At the time, he accused the government of letting “political considerations, delays and implausible justifications for decision-making” cloud the approval process.

In court papers prior to Wednesday’s hearing, Assistant U.S. Attorney Scott Landau said the government had complied with Korman’s orders by lowering the cutoff for over-the-counter sales of the drug from 18 to 17.

He said the plaintiffs “unfairly accuse FDA of bad faith and delay.”

And will wonders never cease. Mayor Michael Bloomberg raised his voice in support of making Plan B morning-after contraceptive available over the counter to young teenage girls. And just where did NYC’s speak-his-mind mayor do this? At a press conference in Queens, NY during an event promoting the President’s Council on Jobs and Competitiveness with none other than Kathleen Sebelius in attendance:

“It would be much better if these young girls didn’t get pregnant, but once that happens I think this should be available,” Hizzoner told reporters.

Speaking minutes later at the same event, Sebelius said: “I felt that the data presented, and justification for [making Plan B available to] all ages, did not match.” [..]

He called FDA director Peggy Hamburg, who served as the city’s Health Department commissioner during the Dinkins administration, a “first rate scientist.”

“I think her advice should be followed,” he said prior to the jobs event at LaGuardia Community College in Long Island City.

Limiting Choice, Putting Young Women At Risk

Cross posted from The Stars Hollow Gazette

This was not a good week for women’s reproductive freedom, especially young women of childbearing age under seventeen. The Secretary of Health and Human Services chose to strike down the Food and Drug Administration’s decision to make emergency contraception available without a prescription to people under 17, just as it is now to those who are 17 and older. It is very obvious that Secretary Kathleen Sebelius based her decision, not on the science that Plan B One-Step is safe, but on pure politics to avoid a confrontation with Catholic Bishops and so-called “pro-life” conservatives in an election year.

President Barack Obama’s statement that he did not intervene in the secretary’s decision is barely believable. What was even more insulting was his paternalistic statement regarding women being able to make their own reproductive decisions using his own daughters:

I will say this, as the father of two daughters. 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.

And as I understand it, the reason Kathleen made this decision was she could not be confident that a 10-year-old or an 11-year-old go into a drugstore, should be able-alongside bubble gum or batteries-be able to buy a medication that potentially, if not used properly, could end up having an adverse effect.

And I think most parents would probably feel the same way.

No, Mr. President this is not “common sense”, this is a dangerous decision that will put thousands of young women at risk for unwanted pregnancies. As a parent, I know full well that children do not always confide in their parents when they have done something the parents will disapprove. Unlike you, sir, parents can’t watch their children 24/7 and children are not known for making good long term decisions, especially, when they are pressured by their peers.

Girls as young as 10 and 11 are having unprotected sex. As available as condoms are, kids don’t always use or have them and, oh, they do break. There is also the matter of rape and incest. Who do these young women turn to when they are too ashamed to seek help because of the backward attitudes about sex in this country?

For EC to be effective it must be taken within 72 hours of intercourse, the sooner the better. The direction for Plan B are simple and easily understood: Take one pill within 72 hours of unprotected sexual intercourse. Directions that most 10 or 11 year olds can easily understand.

So putting constraints to access by requiring a prescription from a doctor, which may not be either timely or possible, further put the young woman at risk. This is a rule that could adversely affect the rest of their lives, economically, educationally, familial and professionally. This is denying them control over their reproductive lives. As the father of two daughters, you might want to about this more carefully.

The President’s remarks were not just paternalistic but uniformed and sexist. I’ll get to the nonsense he spouted about over the counter drugs.

Let me say this, as a medical professional, there are millions of young women who take birth control, some for health issues, with no adverse side effects. Teenage pregnancy carries increased health risks to both mother and infant, even a higher risk of mortality.

The “morning after” pill has been available to all women in their menarche over the counter in Europe for years with little or no ill effect. Dr. Margaret Hamburg, the F.D.A.’s commissioner, in her statement disagreeing with Sec. Sebelius’ veto, stated the agency’s scientists “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 disease.”

Sebelius’ override has been described as “medically inexplicable”:

Sebelius’ decision is “medically inexplicable,” said Dr. Robert Block of the American Academy of Pediatrics, one of a number of major medical groups that contends over-the-counter access to emergency contraception would lower the nation’s high number of unplanned pregnancies.

Pediatricians say the morning-after pill is safe — containing a high dose of the same female hormone that’s in regular birth control pills — especially compared to some existing over-the-counter medicines.

“I don’t think 11-year-olds go into Rite Aid and buy anything,” much less a single pill that costs about $50, added fellow AAP member Dr. Cora Breuner, a professor of pediatric and adolescent medicine at the University of Washington.

Instead, putting the morning-after pill next to the condoms and spermicides would increase access for those of more sexually active ages “who have made a serious error in having unprotected sex and should be able to respond to that kind of lack of judgment in a way that is timely as opposed to having to suffer permanent consequences,” she said.

Sebelius may not have been forthcoming when she said that the drug’s manufacturer had failed to study whether girls as young as 11 years old could safely use Plan B. Teva Pharmaceuticals had funded a study that “tracked 11- to 17-year-olds who came to clinics seeking emergency contraception. Nearly 90 percent of them used Plan B safely and correctly without professional guidance, said Teva Vice President Amy Niemann.”

There are far riskier drugs that are on the shelves of drug stores that are available to teens that can do more harm than a one time use pill that you have to see the pharmacist to get. There are no known drug interactions, yet there are serious warnings about taking Tylenol, aspirin and non-steroidal anti-inflammatory drugs (Ibuprofen, Naprosyn) with a long list of over the counter and prescription drugs. There are diet pills and cough remedies that carry higher risks. A teen driving a car is more dangerous.

For the President to say that he was not involved in the process is laughable on its face. The Executive Branch is controlled by him. All of the cabinet members are answerable to him. No cabinet member would presume to make a decision of this magnitude with the political repercussions without his direct or implicit approval. The buck stops with him.

There is no medical argument that can be made to justify this. It is purely political, pandering to the far right factions that will never vote for Obama even if his were the only name on the ballot. It is feckless, cowardly and a slap in the face to 51% of the population of the United States.