Washington – By the end of the year, American women will be able to walk into any pharmacy and buy emergency-contraceptive pills without a prescription as a result of a Food and Drug Administration decision announced Thursday.
The decision means women will not have to go to a doctor first, as long as they can prove they are 18 or older to a pharmacist, who will keep the drugs behind the counter.
Younger teens will still need a prescription, and the pills will not be sold at gas stations, convenience stores or other outlets that do not have pharmacists.
The approval marks the first time a hormonal contraceptive will be broadly available in the United States without a prescription.
The pills, which will be sold as “Plan B,” will probably cost about $25 to $40 per dose, and men also will be able to purchase them.
The announcement was aimed at resolving one of the longest, highest-profile health controversies of the Bush administration, but opponents said they were considering trying to block the decision, either in court or in Congress.
Anticipating the FDA decision, Colorado Springs-based Focus on the Family’s senior bioethics analyst, Carrie Gordon Earll, criticized the approval earlier this week:
“Selling this drug over the counter to any adult who wants to buy it virtually guarantees that it will end up in the hands of teenage girls without their parents’ knowledge or their doctor’s supervision.
“Over-the-counter status for Plan B – regardless of the age requirement – is an invitation for adult men to pressure underage girls to have sex with the promise of an easily accessible magic pill to prevent or abort a pregnancy.”
Other social conservatives liken taking the pills to abortion because they can sometimes prevent a fertilized egg from implanting in the womb.
Women’s health and family- planning advocates, while criticizing the FDA for the age restriction, hailed the decision as a long-overdue milestone that will make it much easier for women to prevent unwanted pregnancy when they have unprotected sex or when other contraception, such as a condom, fails.
It will be particularly valuable to rape victims, they said.
“This is great news for women and great news for women’s health,” said Cecile Richards of the Planned Parenthood Federation of America.
Kate Horle of Planned Parenthood of the Rocky Mountains called the FDA decision “a really important victory for women.”
Planned Parenthood in Colorado had been a major proponent of a law that would have allowed pharmacists in the state to dispense emergency contraception without a doctor’s prescription.
The bill passed the state legislature but was vetoed by Gov. Bill Owens.
Horle said she was unhappy that the FDA restricted over- the-counter access just to women 18 and older.
“Anything that makes it harder for teens to avoid unintended pregnancy is bad public policy,” Horle said.
The rule will put pharmacists in the position of having to check women’s identification when they ask for emergency contraception.
But Val Kalnins, executive director of the Colorado Pharmacists Society, said that shouldn’t be a problem.
The society, which represents about 755 pharmacists statewide, supported the state law and supports the FDA’s decision, Kalnins said.
Plan B, which consists of two pills containing a synthetic version of the hormone progestin used in standard birth-control pills, is highly effective at preventing pregnancy if taken within 72 hours of unprotected intercourse (long before pregnancy tests usually work).
FDA officials said they had concluded after further review that there was too little safety data to approve the drug for teenagers under 18.
But the agency ruled that the drugs could be sold safely to those 18 and older because similar restrictions are already placed on other products, such as tobacco, nicotine and cold remedies containing pseudoephedrine.
“This approach builds on well-established state and private-sector infrastructures to restrict certain products to consumers 18 and older,” acting FDA Commissioner Andrew von Eschenbach wrote in a memo outlining the decision.
Denver Post staff writer Karen Augé contributed to this report.
About the “morning-after pill”
Name: Plan B.
Manufacturer: Barr Pharmaceuticals Inc.
Use: If taken within 72 hours of unprotected sex, it can lower the risk of pregnancy by up to 89 percent.
What it is: A high dose of a drug found in many regular birth-control pills.
What it isn’t: It’s not an abortion pill. It prevents ovulation or fertilization of an egg; it also may prevent the egg from implanting into the uterus, although recent research suggests that’s unlikely. It has no effect on women who are already pregnant.
Who can buy it: Under the FDA approval, women ages 18 and older can buy it without a prescription. Those 17 and younger would still need a prescription.
Pros: Advocates say it can cut in half the 3 million unplanned pregnancies that occur every year in the United States.
Cons: Opponents fear wider access to the pill could promote promiscuity.
