U.S. Rules Morning-After Pill Can't Be Sold Over the Counter

Federal drug regulators yesterday rejected a drug maker's application to sell a morning-after pill over the counter because of concerns about whether young girls would be able to use it safely.

The Food and Drug Administration told the pill's maker, Barr Pharmaceuticals, that before the drug could be sold without a prescription the company must either find a way to prevent young teenagers from getting it from store shelves or prove, in a new study, that young girls can understand how to use it without the help of a doctor. Company executives expressed confidence that they could clear those hurdles, although it was unclear how long that would take. The decision was a surprise because in December, a panel of independent experts assembled by the Food and Drug Administration voted 23 to 4 to recommend that the drug be sold over the counter. The majority concluded that the drug was not only effective but that women could be trusted to use it correctly without a doctor. The Food and Drug Administration normally follows the recommendation of its advisory panels.

I highlight the part about their concerns that "young girls" wouldn't be able to use it "safely" without a doctor's supervision. I guess they think grown women couldn't use it safely on their own either, showing once again the misogyny permeating the federal government right now. I am sick of it. We need to get these female-hating bastards out of there.

link>http://www.nytimes.com/2004/05/07/health/07FDA.html?8br

Didn't you get the memo?

I'm heading back to the kitchen now. My man will want some lunch soon.

:P

RV

Things will be changing soon. Like, in November!

I was watching a show, and Doctor Drew was on (from Loveline) and he was talking about the morning after pill. he said the cinical trials showed zero side effects from long term use. It is as safe as any other over the counter drug, and there have been no reports of ill side effects. It's in the same league as extra-strength tylenol.

I'm so sick of fundamentalists running this God-damned country.

According the to the Times article, Barr Pharmecuticals was only informed last night via a faxed letter. The Times article is dated today and I got the email this morning about this decision.

don't know, but it was covered on All Things Considered last nite too! Who knows how our government works! Did they release the letter to Barr to us first?

The FDA complained that Barr provided no evidence that teens under 16 could use the pills appropriately without a doctor's guidance. Warned in February of that concern, Barr offered a last-minute proposal to allow nonprescription sales to anyone 16 and older — and make drugstores check ages and demand a prescription from younger teens.

But the FDA said the company didn't provide necessary details on how such a program, never before tried, would work. It said, though, it would reconsider if Barr provided more details and teen data.

How would such a program work? DUUUHHHH!!! Same way as with smokes... stick a big friggin' sign on the counter, and educate your clerks to ask for proof of age if they're in doubt.

Studies on college campuses show a decline in pregnancy and abortion with wider availability of the morning-after pill.

The Religious Right can't argue the abortion angle with this one... at least the intelligent ones. So they just fall back on the old "sex is bad" routine...

Afterward, the FDA came under months of intense political pressure from conservatives who argued that unfettered access could encourage more teen sex.

Encourage more teen sex... like teens need encouragement!

:bounce:

(Source: http://www.foxnews.com/story/0,2933,119248,00.html)

Now I'm waiting for him to try to ban shoes!

intervention - all of which can kill us and do more harm than a misused morning after pill.

Jesus Christ, these people are idiots. All it would take is to require over the counter sales to adults only with an ID. Big Whoop.

I don't think it's a drug that should be sold without a prescription. This is a serious chemical that could have really bad side effects on a woman's body. It also could cause interactions with other drugs. It's much different from ibuprofin or tagamet hb, or other former prescription drugs that are now sold over the counter. A doctor needs to monitor a woman who is given this drug.

4. Pediatric use. The safety and efficacy of COCs have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under 16 and users 16 and older. Use of this product before menarche is not indicated.

OVERDOSAGE

There have been no reports of serious ill effects from overdosage of combination oral contraceptives, including ingestion by children.

http://www.preven.com/prodinfo/prescinfo.asp

In other words, even if a 9-year-old boy somehow walked into a pharmacy, plunked down $30 or shoplifted the kit and took all of the pills at once, there won't be serious problems.

And, for comparison's sake, the warning on a package of Flinstones Chewable Vitamins plus iron -- the medicine designed to look and taste like candy. Don't tell me than children can handle these things safely without adult guidance:

Warnings

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

So..."no reports of serious ill effects" vs. "leading cause of fatal poisoning."

There is a compromise solution: behind the counter, non-prescription dispensing.

That's how codeine products are handled in Canada. Every winter, I go to the drug store around the corner for my 250 ml of generic Benylin + codeine so I don't spend two weeks coughing myself awake. I ask the pharmacist for it, she asks whether I've taken codeine before, I say blahblah cough cough, and home I go. On the other hand, a pharmacist will not dispense codeine to someone who is obviously a drug-seeker (I've seen that happen).

Pharmacists are professionals -- not just in the common meaning of that word, but in the technical meaning. They are governed by a code of professsional conduct and ethics. It is part of their job to ensure that clients are appropriate candidates for the medications they dispense (by inquiring about risk factors, e.g.), and know how to take the medications and what effects to expect from them.

The objection to emergency contraception being sold from behind the counter is that some young/vulnerable women might be reluctant to ask for it. Of course, there's also the recent problem of *un*professional pharmacists objecting to dispensing emergency contraception, and this might result in interference in some women's exercise of their reproductive rights, if a pharmacy stocked the medication but a particular employee pharmacist got stroppy about dispensing it.

That sort of thing should not be a consideration in deciding how a medication will be dispensed. Unfortunately it is.

So balancing the potential harm if emergency contraception is sold from behind the counter -- some women's reluctance to ask for it and the possibility that some pharmacists would interfere improperly -- against the potential harm if it were sold over the counter -- pretty much nil -- over the counter is the best answer.

But if a compromise were needed for expediency, to get the medication to the most women who need it as efficiently and effectively as possible, given the political barriers to over the counter purchase, there is simply no reason why behind the counter dispensing could not be approved.

.

There are PLENTY of OTC drugs that can cause harm and we are allowed to take as many of them as we want. You mentioned ibuprofen. I personally do not take it as it can cause bleeding in the stomach. Tylenol (acetaminophen) has the very real potential of causing irreversible liver damage with overuse. The FDA approved those for OTC. This is politics, pure and simple. You're argument has no merit.

O-boy a new source of income for the independent street corner pharmacy. RU 487 too.

IMHO

180

are BULLSHIT. It just sounds so justifiable that we're only thinking about harm that may come to the sweet young things.

If you can read you can use EC safely.

Take this set of pills now, take next set of pills x hours after first set.

Rocket science.

I had to write an exhaustive article about EC a few years ago, the worst side effect experienced was nausea....you know like the kind you get with an unintended pregnancy only not as bad.

and that is what this boils down to-- and it is unfortunate that women will be forced into either a pregnancy or an abortion because this pill will not be readily available--on a Sunday or holiday , say.

I do not trust the corporate Pharm industry, or the federal, Food and Drug association. They are being funded by the government--and the way to continue that funding, and the way to insure the salaries and the job, is to cowtow to the political will of those in power.

In this case, it is to force young women into pregnancy.

The FDA decision to restrict the "morning after" pill to prescription-only is yet more Dubya Bush voodoo medicine, except this time it's public health, not economics.