Judge orders FDA to let 17-year-olds use Plan B

NEW YORK – The Food and Drug Administration let politics cloud its judgment when it denied teenage girls over-the-counter access to the Plan B morning-after pill, a federal judge said Monday as he ordered the FDA to let 17-year-olds obtain the medication.

In a thorough denunciation of the Bush administration, U.S. District Judge Edward Korman blasted the FDA's handling of the issue, saying it had "repeatedly and unreasonably" delayed issuing a decision on the medication.

The morning-after pill is a source of tension for social conservatives who held great sway in the Bush administration and who believe the pill is tantamount to abortion.

The ruling said the FDA in several instances had delayed issuing a ruling for suspect reasons and on two occasions only took action to facilitate the confirmation of acting FDA commissioners whose confirmations had been held up by the repeated delays.

"These political considerations, delays, and implausible justifications for decision-making are not the only evidence of a lack of good faith and reasoned decision-making," Korman said. "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."

The drug is marketed by Montvale, N.J.-based Barr Pharmaceuticals Inc. as Plan B. Korman ordered the FDA to permit Barr Pharmaceuticals to make Plan B available to 17-year-olds without a prescription under the same conditions as Plan B is now available to women over the age of 18. He said his order must be complied with within 30 days.

The FDA said it is reviewing the judge's decision. Women's groups said it's unlikely that the Obama administration would appeal. Social conservatives decried the ruling.

Susan Wood resigned as the top FDA official for women's health in 2005 to protest agency delays in issuing a decision on the morning-after pill. Now a professor at George Washington University's school of public health, Wood said the ruling represents a vote of confidence in the FDA's scientific staff.

"What happened with Plan B demonstrated that the agency was off track, and was not being allowed to do its job properly," Wood said. "This is telling the FDA to move forward with a focus on good science."

The conservative Family Research Council said the judge's decision bowed to ideological pressure from the left.

"Judge Korman has accepted lock, stock, and barrel all of the claims of a political ideology promoting sexual license for teens," said Chris Gacek, a regulation expert with the group.

"There is a real danger that Plan B may be given to women, especially sexually abused women and minors, under coercion or without their consent," Gacek added in a statement.

In February 2001, the Association of Reproductive Health Professionals and 65 other organizations petitioned the FDA to make Plan B available over the counter to all, regardless of age. The FDA did not respond for five years, announcing in 2006 that the petition was denied.

As part of his order, Korman vacated the petition's denial and required the FDA to reconsider its decisions regarding the Plan B switch to over-the-counter use.

The lawsuit was filed in 2005 by the Center for Reproductive Rights and others.

In his ruling, Korman noted that FDA officials as far back as June 2002 discussed the "political sensitivity" of making Plan B available over the counter.

And he said depositions by several FDA senior staff members revealed that political and ideological factors played an important role in the nomination and selection process of members of FDA committees that would recommend how the FDA should act on Plan B requests.

One doctor testified that the FDA commissioner's office appointed members to its advisory committee not for their expertise but to achieve a "balance of opinion," meaning they were very active in the anti-abortion movement, Korman said.

Still, the FDA's Advisory Committee voted 23 to 4 in 2003 to approve Plan B for over-the-counter status without age restrictions. However, out of nearly two dozen applications to move a prescription drug to over-the-counter status, the Plan B request was the only one not approved after the committee recommended it.

The judge said top FDA officials at a meeting in late 2003 or early 2004 told their subordinates that over-the-counter status for Plan B would not be approved at that time and that it was a decision that would be made at a higher level in the FDA than those decisions are usually made.

"Moreover, they were told that the White House had been involved in the decision on Plan B," he said.

"Today's ruling is a tremendous victory for all Americans who expect the government to safeguard public health," said Nancy Northup, president of the center.

Assistant U.S. Attorney F. Franklin Amanat, who argued the case for the government, said: "We're studying the decision and evaluating options."

"We need to discuss it with the agency and figure out what our next steps will be," he said.

The government in court papers has said politics played no role in the agency's decisions.

Plan B is a contraceptive that reduces the chance of pregnancy if taken within three days after sex. It contains a high dose of of birth control drugs. The drug works by preventing ovulation or by interfering with implantation of a fertilized egg. Opponents argue that is the equivalent of abortion.

In 2006, the FDA allowed Plan B to be sold without a prescription to adults, but only by pharmacies that checked photo ID before selling the pills. Girls 17 and younger were required to obtain a prescription.

Barr is now owned by Teva Pharmaceutical Industries, a global company headquartered in Israel.

___

Associated Press Writer Ricardo Alonso-Zaldivar in Washington contributed to this story.

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What are your thoughts on this?

I dont think it should be avilable to 17 yr olds. 18 is when you are considered an adult. In states where parental consent is needed for medications prescribed by a doctor, where a 17 year old wouldnt be allowed to buy certian over the counter cold meds, they shouldnt have access to an OTC plan B. They can still go to the ER and get it. But I dont think it should be handed out to 17 yr olds.

17 year olds are going to have sex. Would you rather them have the children?

No that is not what I am saying at all. I am saying that if certian cold medications are not legally allowed to be given OTC to minors, then why are they making an exception for plan B? There are other ways of getting Plan B then at your local drug store

Because a cold medication is completely different than a birth control pill. There are different doses for children then there are for adults. The reasoning for this birth control pill to be 18+ is a moral issue, and quite frankly, teenagers WILL have sex. Then it comes down to have the kid or abortion. Both suck.

agreed!

Plan B isnt birth control, and should not be used as such.

Yes it is. It's used after sex to prevent pregnancy. What do you think it is? :|

I know what it is, I've taken it before, and it specifically says "Not to be used as birth control", it also says it on the commericals too. It isnt something that should be taken like a birth control, do you understand what I'm saying (not trying to be rude, but people shouldnt think that everytime they have unprotected sex they should keep taking this)

So if it's not birth control, what exactly is it? Because it's being advertised as birth control.

This was taken off the website, and this is what I meant

" Do not use Plan B®:
If you're already pregnant, because it won't work
If you're allergic to levonorgestrel or any of the ingredients in Plan B®
In place of regular birth control. Plan B® should not be used as routine birth control, as it isn't as effective. Plan B® won't protect you from HIV infection (the virus that causes AIDS) or any other sexually transmitted disease (STD)."

I just failed to use the word routine....

So... it is birth control... but it doesn't work if you are already pregnant. And it doesn't protect against HIV or other STDs. It's exactly the same as every other form of birth control.

Spoilers:

It's birth control.

It's not birth control lol.
It's an emergency contraceptive.

It doesn't work after like 48 hours of the condom breaking or what have you.
This stops a fertalized egg from implating in the uterus.
Birth control itself stops ovulation, so that there are no eggs.

biiiig difference, yo.

There are not different doses for 16 and 17 year olds. 16 and 17 year olds are adults as far as administration of medicines go. Under that age it should be based on weight, but based on weight, most 13 - 15 year olds would also get adult doses.

Well in all honesty, OTC medications are much different than plan B.
You can't over-dose on plan B. Plan be doesn't have psudephedrine in it, and can't be used to make meth.

They're making the exception because it's better to allow 17 year olds access to plan B, than to have them wind up pregnant, only to preform at-home abortions and injure themselves, or add another child to the foster homes. Not saying that's the case with all teenage pregnancies. But I'd rather a 17 year old be given plan B, than to have any of that happen once.

Oh, is that the reason why there's age restrictions there?? Because teenagers are using pseudoephedrine to make meth?! How random. Apparently British teenagers aren't that creative then, since I'm pretty sure 16 and 17 year olds here are allowed to buy cold medicines containing pseudoephedrine.

Part of the reason, yes. The ones with higher amounts of it are placed behind the counter, and stores aren't allowed to sell more than like, two things containing it to a single customer.

Haha, not here! You can't buy a lot of things here under the age of 18. I know a few things I wasn't allowed to buy at our Wal-Mart until I was 18 were cold medications containing pseudoephedrine, spray paint, some cleaning supplies, some brands of strong markers... thats all I can think of at the moment. All because kids who wanted to sniff crap and/or make meth.

Significantly more likely, they're buying drugs containing dextromethorphan and getting high directly off of that. (Aka Robitussin DM = Robotrippin.)

Dextromethorphan is the little brother of drugs such as ketamine and phencyclidine (PCP). It causes hallucinations and euphoria. Yes, making meth is a problem, but they usually just limit the number of boxes you can buy, or keep them behind the counter to discourage stealing. The whole age-limit thing is probably more focused towards keeping kids from taking the dextromethorphan.

I'd argue that 16 and 17 year olds are probably also mature enough to buy their own cold medicines. Again, I don't believe there are such age restrictions here.

Oh I agree. My point isn't that from a maturity standpoint they shouldn't be able to get plan B. Only that from a legal standpoint there needs to be more consistency on what a 17 yr old can get OTC. Either everything that an adult can, or nothing that an adult can.


I would much rather have a young woman be able to have access to plan B then get pregnant. Guess I should of just kept quiet on it ;)

Then I think they should be allowed to buy everything that an adult can. They can in the UK, and as far as I'm aware, it hasn't led to a surge in teenager-manufactured meth! Given the other things 16 and 17 year olds are considered responsible enough for, I really think buying OTC medications is pretty trivial.

its not that just teenagers are making meth with it, teenagers are using cough syrup to get high and drunk off of. thats why there is the over 18 to buy it law. and you can only buy 2 pack of anything with the psuedophedrine in it, thats because people were using it to make meth. if you go to a store in the U.S they will ID you to make sure you are of age in either situation. hope that helps!

High and drunk from cough medicine, what on earth do you put in it over there?!