Vermont looks to increase Plan B availability Drive to sell emergency contraceptive over the counter turns political

Author: Caroline Stauffer

Vermont is likely to pass legislation that would permit the sale of Plan B emergency contraception in select pharmacies, though Food and Drug Administration (FDA) approval for over-the-counter sales of the drug is delayed indefinitely.

Plan B, which consists of a pair of Progestin-only tablets and is also referred to as the morning after pill, replaced the so-called Yuzpe Regimen as the preferred method of preventing pregnancy after sexual intercourse when the drug was introduced in the United States in 1999.

In response to owner Barr Laboratories' request for over-the-counter status for Plan B, the FDA formed an advisory committee. The committee voted 23-4 in favor of legalizing over-the-counter sales in December 2003. However, in May 2004, the FDA management rejected the company's application, citing concerns about the effects of over-the-counter availability on the sexual behavior of young women. The FDA is currently considering a proposal that would offer over-the-counter access for women age 16 and older, but would still require prescriptions for younger women to use the drug.

Some states have adopted the policy of collaborative practice to increase the availability of Plan B. "Collaborative practice allows pharmacists and physicians to enter into an agreement in which the pharmacist acts in terms of a protocol a physician has laid out," Jessica Oski, vice president for Public Policy and Government Affairs at Planned Parenthood of New England, explained.

Seven states have passed collaborative practice legislation so far, including Maine and New Hampshire, and the Massachusetts legislature has passed a similar bill over Governor Mitt Romney's veto.

Availability through a state collaborative practice agreement differs from FDA-approved over-the-counter status in that selling the drug is purely voluntary. Furthermore, pharmacies wishing to sell the drug must undergo special training before they can sell Plan B, and purchasers must answer a series of questions and give their name to the pharmacist. Oski pointed out that increased access via collaborative practice is often marginal. Only six pharmacies are currently actually selling Plan B in Maine, for instance.

Last May, the Vermont House of Representatives passed H.237 "An Act Relating to Emergency Contraception," introduced by Rep. Harry Chen (D-Mendon) an emergency room physician. The Vermont Senate will take up the Bill, which would expand access to Plan B in Vermont through collaborative practice agreements, when the new session starts in Montpelier next January. It is expected to pass, and Governor Jim Douglas has voiced his support.

Thus far, the only opposition to the Bill in Vermont has come from the Catholic Church, which does not support any form of birth control. Vermont Right to Life does not oppose Plan B because the organization believes it is a safe method to prevent pregnancies and is not an abortive drug.

FDA approval of Plan B has undeniably been hindered by political and ethical concerns. Critics argue that the FDA has been overly influenced by social ideology and disregarded scientific evidence guaranteeing Plan B's safety and efficacy in preventing unwanted pregnancies.

Editorial pages such as The Boston Globe's on Aug. 31 have lobbied for FDA approval of Plan B without age restrictions. Planned Parenthood vigorously supports any and all efforts to make Plan B more widely available.

Oski disagreed with the idea that making Plan B readily available at pharmacies would lead to more irresponsible sexual behavior in young women, citing unpleasant side effects and the drug's cost as deterrents to frequent use. "If you go to a pharmacy, you aren't going to get out of there paying less than $40 for Plan B," she said.

Oski also noted the efforts of Barr Laboratories to educate about Plan B through targeted advertising, which is often aimed at college-aged women.

Mark Peluso, director of the College's Parton Health Center, expressed reservations about over-the-counter sale of Plan B."Because the drug involves pregnancy, the issue gets politicized," he said. "I don't have political issues with the sale of Plan B over the counter, but for young teens to have the ability to buy a drug like that ... there is something to be said for a medium of control. Pregnancy should be met with nonjudgmental education."

Peluso also highlighted the increased difficulty of comprehensively studying the effects of Plan B on younger women due to the necessity of obtaining parental consent. He worries about an increase in sexually transmitted diseases if young women see pregnancy as the only consequence of unprotected sex.

Although he did not have exact numbers, Peluso said Plan B prescription is a "fairly frequent business" at the College. He pointed out, however, that it is impossible to determine how many doses are taken in response to actual errors in contraception and how many are taken out of anxiety.

Peluso said he would want to examine the profit motives of selling Plan B over the counter. It would conceivably be much less expensive for consumers to obtain the pills from a pharmacy than it would be to visit a physician and obtain a prescription, but the drug company's profits would certainly increase.

The Health Center charges $12 for a Plan B treatment to cover costs, but as with all medicines and treatments, does not seek to make a profit.

Peluso was unsure what the Health Center's reaction would be if Plan B were made readily available at local pharmacies - the Center does not carry many over-the-counter drugs and endeavors not to compete with local businesses - but he does urge women to use the College's resources regardless.

"Students have easy access to medical providers here, so why not come and take advantage of our services, whether or not we are the primary source for Plan B?" he said.