After a great deal of bickering and investigating and politicking, the morning-after-pill will be available without a prescription, over-the-counter, just like Sudafed.
WASHINTGON (AP) -- Women can buy the morning-after pill without a prescription, the government declared Thursday, a major step that nevertheless failed to quell the politically charged debate over access to emergency contraception.
The manufacturer, lawmakers and other advocates said they will press the government to allow minors to purchase the pills over the counter.
The Food and Drug Administration said that women 18 and older — and men purchasing for their partners — may buy the Plan B pills without a doctor's note, but only from pharmacies.
Girls 17 and younger still will need a prescription to buy the pills, the FDA told manufacturer Barr Pharmaceuticals Inc., in ruling on an application filed in 2003.
The compromise decision is a partial victory for women's advocacy and medical groups, which say easier access could halve the nation's 3 million annual unplanned pregnancies.
"While we are glad to know the FDA finally ended its foot-dragging on this issue, Planned Parenthood is troubled by the scientifically baseless restriction imposed on teenagers. The U.S. has one of the highest rates of teen pregnancy in the Western world — anything that makes it harder for teenagers to avoid unintended pregnancy is bad medicine and bad public policy," president Cecile Richards said.
Opponents contend that nonprescription availability could increase promiscuity and promote use of the pills by sexual predators.
"If the FDA thinks that enacting an age restriction will work, or that the drug company will enforce it ... then they are living in a dream world," said Wendy Wright, president of Concerned Women for America, who led the opposition.
Plan B contains a concentrated dose of the same drug found in many regular birth-control pills. Planned Parenthood estimates 41 other countries already allow women to buy emergency contraception without a prescription.
If a woman takes Plan B within 72 hours of unprotected sex, she can lower the risk of pregnancy by up to 89 percent. Plan B is different from the abortion pill: If a woman already is pregnant, Plan B has no effect.
The earlier the pills are taken, the more effective they are. Allowing nonprescription sales mean women won't have to hustle to get a prescription, something especially difficult on weekends and holidays, advocates said.
In this discussion, I'm going to put aside the moral issues and look at this from a purely public health perspective.
Question: Why would the Plan B oral contraceptive be made available over-the-counter?
I understand the time constraints, the weekend and holidays thing; but we're talking about women's health.
Antibiotics, for example, aren't made available over-the-counter when the doctor's office is closed.
Is it inconvenient to get immediate medical care on the weekends and during holidays?
Did you ever have a child develop an ear infection on Christmas Eve? Did you ever then have another child develop an ear infection on New Year's Eve?
That's a nightmare.
Yes, it can be very inconvenient to get a prescription. But when has that ever been used as a justification to make a prescription pill or medication available over-the-counter?
To obtain oral contraceptives, one must go to a doctor for a prescription.
Even after years of successful and safe use, it's typical for one to be required to go in for an annual check-up to get an oral contraception prescription refilled.
My point is obtaining oral contraceptives requires a doctor's approval.
Now with Plan B, the doctor is totally out of the picture.
Are daily low dose oral contraceptives going to be made available over-the-counter? Why not?
I fail to see how giving easy access to Plan B is looking out for the health of women.
Women could opt for the simple over the counter method and subject themselves to high doses of hormones on a somewhat regular basis.
High dose pills can have serious health consequences for women.
And these issues don't even begin to touch on the potential for abuse of Plan B by sexually active girls.
Barr hopes to begin nonprescription sales of Plan B by the end of the year. The pills will be sold only from behind the counter at pharmacies, but not at convenience stores or gas stations. Pharmacists will check photo identification.
There isn't enough scientific evidence that young teens can safely use Plan B without a doctor's supervision, von Eschenbach said in a memo. Over-the-counter use is safe for older teens and adults, the acting FDA commissioner added in explaining the age cutoff.
Is Plan B safe if it's taken regularly, even for adults?
I don't see how it could be.
"This approach should help ensure safe and effective use of the product," wrote von Eschenbach.
Barr and others were disappointed that FDA imposed the age restriction. Bruce L. Downey, Barr's chairman, pledged to continue working with the agency to try to eliminate it.
The age restriction remains controversial even inside FDA, agency drugs chief Dr. Steven Galson told The Associated Press. Galson has acknowledged overruling his staff scientists, who concluded in 2004 that nonprescription sales would be safe for all ages.
"Let me be frank, there still are disagreements," Galson said in an interview. "There were disagreements from the first second this application came in the house."
The Center for Reproductive Rights said a lawsuit filed last year to do away with all age restrictions would continue.
Consuming high dose hormone pills is not the same as making condoms available to children.
I think this supposed victory for women's rights actually serves to endanger them in the long run.
A doctor should be involved in dispensing Plan B.
This over-the-counter move is certain to put some girls and women at risk.
As a condition of approval, Barr agreed to use anonymous shoppers and other methods to check whether pharmacists are enforcing the age restriction.
Anonymous shoppers? Barr has to be kidding.
What a joke!
...The FDA approved prescription-only sales of Plan B in 1999. The quest to change its status began in 2003. That year, agency advisers endorsed nonprescription sales for all ages, and FDA's staff scientists agreed.
Higher-ranking officials rejected that recommendation, citing concerns about young teens using the pills without oversight. Barr reapplied, asking that women 16 and older be allowed to buy Plan B without a prescription. Then last August, the FDA postponed a final decision indefinitely, saying the agency needed to determine how to enforce the age restrictions.
I really don't get this.
Adults and children are required to have a doctor or qualified health professional's oversight to use oral contraceptives.
Why? It's in their best interests regarding their health in the long term.
Why would all that preaching about the need to be under a doctor's care when using oral contraceptives suddenly be tossed out?
I think there needs to be a Plan C.
The potential for abuse of this over-the-counter method is extremely high.
That's not protecting the health of women. I don't think it empowers them. To the contrary, I think it exposes them to potential health risks.
No comments:
Post a Comment