Tag: Food and Drug Administration

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.

The politically motivated decision to block the sale of Plan B Emergency Contraception to under seventeen year old women without a prescription by Health and Human Services Secretary Kathleen Sebelius that was blessed by President Obama has outraged women’s groups, doctors and, yes, the FDA.

Amanda Marcotte expressed her views on Obama using politics to trump science, common sense and good parenting:

No one wants 11-year-olds to have sex, of course, but that concern shouldn’t play a role in this. In a press release addressing Sebelius’s decision, the Guttmacher Institute, a nonpartisan research institute that studies sexual health, noted that fewer than 1 percent of 11-year-olds are sexually active, but almost half of teenage girls are having sex by age 17. There’s no evidence to suggest that making Plan B available to all teenagers will somehow push younger teenagers to start having sex in greater numbers. If Sebelius actually had concerns about the effect of this drug on the behavior of younger teenagers, she could have looked to Canada, where Plan B is sold over the counter without age restrictions, with no discernible outbreaks of promiscuity in junior high school. Meanwhile, the United States still has a teen birth rate three times that of Canada’s, which easy access to Plan B could help curb.

Over the past decade, more than 70 medical organizations, the bulk of the FDA’s review committees, the Union of Concerned Scientists, and the Center for Drug Evaluation and Research have all endorsed selling Plan B over the counter with no age restrictions. The only person left standing against the switch is a career politician with a background of lobbying on the behalf of trial lawyers, whose job depends on her boss getting re-elected. Sebelius’s claim that she’s standing up for better science instead of pandering to American fears about teenage sexuality sounds hollow. As hollow as all those Republicans who flaunt the experts to deny climate change.

Why Obama’s ‘Plan B’ Decision Is Wrong

Health and Human Services Secretary Kathleen Sebelius has stunned the women’s health community by halting the implementation of over-the-counter sales of the Plan B morning after emergency contraceptive pill to girls under the age of 17. Now, President Obama has come out saying that – as a father of two girls – he supports Sebelius’ common sense move. But was it a common sense move, Mr. President? Offering Plan B over the counter would have helped stem the tide of teenage pregnancies in America. Sure, Plan B is currently available to younger girls with a prescription, but many girls won’t or can’t get to a doctor in the first 72 hours after having unprotected sex. And sometimes those who do are running into activist doctors who refuse to write a prescription or activist pharmacists who won’t fill it, leaving girls out in the cold having to face a much more invasive abortion to terminate a potential pregnancy. And it’s not like plan B is a dangerous drug, it’s simply got a stronger dose of the hormone progestin than what’s found in regular birth control. If it’s a safety issue, there are far more dangerous things a 13 year old girl could walk into Rite Aid and buy. Any fear that the wider availability of the pill would increase sexual promiscuity ignores the fact that the pill isn’t cheap, plus a lot of stores would keep them in those locked cabinets with the condoms so kids couldn’t easily steal them.

The truth of the matter is that science and common sense clearly pointed in one direction, but the politics of the situation in an election year pointed in the other. It’s just a shame that the Obama administration chose what’s politically convenient over what’s really best for the nation’s daughters–making sure they don’t put their lives on the slow track by having a baby at age 14, 15, or 16. If you agree with me, help spread this message.

The Food and  Drug Administration approved the Plan B morning after contraceptive pill to be sold over the counter. But on Wednesday the Obama administration overruled the decision. Dr. Susan Wood, former FDA Assistant Commissioner for Women’s Health, joined Chris Hayes and his panel to talk about the controversial intervention.

Jon Walker summed up that this is what pro-choice groups and pro-choice women legislators in the House get for not fighting Obama’s alliance with Bart Stupak over restricting access to abortion in the ACA bill and, again, when Republicans prevented the District of Columbia from using city money to pay for abortion:

During the health care reform fight the women’s reproductive rights groups and legislators were basically sold out. President Obama decided to cut a deal with Bart Stupak’s Gang. He assumed that the pro-choice and women legislators in the House and pro-choice groups would just fall in line, and they did with very little fighting. [..]

Today Obama did it again. Obama’s Secretary of HHS, in a blatant, politically motivated move, took the almost unheard of step of going against FDA recommendations regarding Plan B. Science, common sense and women’s reproductive rights were all disregarded in what clearly appears to be an attempt to appease conservatives.

This is what happens when you don’t fight the first time.  This is what happens when there is no political cost for crossing you. People learn that they can walk all over you, and they do so whenever possible.

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.