Catania bill seeks to provide birth-control pills over the-counter

By Tim Craig
Washington Post Staff Writer
Tuesday, February 15, 2011; 10:42 PM

A D.C. Council member introduced a bill Tuesday aimed at allowing women to bypass the doctor's office and get birth-control pills directly from a pharmacist.

If passed by the council and approved by regulators, the proposal could upend a long-established medical practice of dispensing the pills only with a prescription.

Council member David A. Catania (I-At Large), who introduced the bill, said the District and states need to make more preventive medicine available without requiring costly visits to a doctor.

"At this point, in this city, it's already a challenge for many women in underserved communities to get the appointments and then find a pharmacy," he said. "I think it's a way to expand access to contraception and to conserve valuable resources."

Catania has the support of Planned Parenthood, which long has argued that birth control should be more readily available to women. The bill is viewed skeptically by doctors and could push the city into conflicts with antiabortion groups and Food and Drug Administration regulations.

"It raises more questions than can possibly be answered at this point," said K. Edward Shanbacker, executive vice president of the _blankMedical Society of the District of Columbia. "It has certainly caught our attention, and the first question we will ask is, 'Is it good medicine?' "

If the legislation is approved by the council, the city would authorize its _blankBoard of Pharmacy and _blankBoard of Medicine to work together to "develop and promulgate" regulations that would allow a pharmacist to furnish hormonal birth control - primarily birth-control pills - without a prescription.

Catania's legislation does not set age restrictions on who would be able to obtain birth control from a pharmacist, saying that such decisions should be left up to the boards as part of the rulemaking process.

How far the District - which long has had a liberal reputation for promoting condoms and other forms of contraception - can go in allowing pharmacists to dispense birth-control pills is unclear.

Possible clash with FDA

In 2006, the FDA approved the sale of Plan B, the so-called morning-after pill, over the counter to women who are age 18 or older.

But the FDA long has maintained that daily usage of birth-control pills should be monitored and prescribed by a physician, largely to limit side effects or possible interactions with other medicines.

Shelly Burgess, an FDA spokeswoman, said Catania's proposal could fall within a "gray area" if the city's Pharmacy Board signs off on it.

Although she said the FDA "can say if [a] drug has to be dispensed by prescription or not," the agency usually steers clear of regulating the "practice of medicine."

"It's not something we can definitively speak about as it being against FDA regulations," Burgess said. "It depends."

Catania, chairman of the council's Committee on Health, argues that the District would not be in violation of FDA standards because the pharmacies would not be selling the hormonal contraceptives "over the counter." Instead, he said, a pharmacist would work with individual customers to provide the safest products and options, much like a doctor spends time with a patient.

"This is not going to be the Wild West," said Catania, who is known for pushing to increase condom availability in the city in the past decade. "Pharmacists are extraordinarily overeducated for what they do on a day-in and day-out basis. There is a lot of capacity for a pharmacist to do more than they do."

Oregon program

From 2003 to 2005, Catania said, there was a pilot program in Seattle that allowed pharmacists to dispense oral contraception. About two dozen pharmacists provided hormonal contraception - in pills, patches or rings - to almost 200 women.

Some European countries allow oral contraception to be sold without a prescription.

In the United States, the program closest to the one under consideration in the District was in Oregon, council officials said.

Operated by Planned Parenthood of Columbia/Willamette, the "instant birth control" program allowed patients to apply online to receive the drugs. Applicants then spoke with doctors or nurses via phone before their birth control was issued.

The program was phased out last year.

Like in that program, pharmacists in the District most likely still would be expected to partner with a doctor - at least tangentially - before they could dispense birth control on their own, several health officials said. The relationships would be similar to those created to allow pharmacists to issue some vaccines.

"We appreciate Catania's efforts to increase access to family planning to D.C. women, and we support any effort to break barriers to access," said Laura Meyers, president of Planned Parenthood of Metropolitan Washington.

The issue already has caught the attention of antiabortion groups, and it could complicate relations between the city and Republican legislators on Capitol Hill.

Jim Sedlak, vice president of the American Life League, said the council was considering a "very dangerous bill." Birth-control pills "kill babies" and can be harmful to users, he said.

"A woman needs to be informed, and she is not going to be informed if she just stops by the pharmacy and picks them up," Sedlak said. "We know they are liberal, but they should care about the health of women."

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