Federal Committees Vote to Allow Over-the-Counter Sale of Pill
WASHINGTON — “Twenty-seven upstanding young men. Thirty-six million sneaky little sperm.”
“So many men. So many reasons to have backup contraception.”
These are slogans from the new ad campaign for Plan B, a drug known as the “morning-after pill” that is taken in tablet form within 72 hours of intercourse without contraception to thwart a pregnancy.
The ads feature groups of young college-age men and imply that college girls will be sleeping around — and not using contraception.
Now the FDA is considering a proposal by the Women'd Capital Corp., the distributors of Plan B, to have “emergency contraception” available over the counter. And two federal advisory committees voted Dec. 16 in favor of the proposal that could soon make buying the tablets as easy as buying aspirin.
But the U.S. Conference of Catholic Bishops thinks American women and girls could take life-threatening risks if the FDA approves that vote.
“American women and children do not deserve this reckless experiment on their lives,” said Cathleen Cleaver Ruse, a spokeswoman from the bishops’ conference'd Secretariat for Pro-Life Activities.
What's more, women and girls who take the drug — a synthetic hormone called levonorgestrel that has been available with a doctor'd prescription since 1998 — might not even know it can cause an early abortion.
“It is marketed and advertised as a contraceptive, but it works both before and after conception, and that is very meaningful to many women who would not take it if they knew,” Ruse said.
Emergency contraception, often confused with the abortion drug RU-486, is promoted as an “oral contraceptive.”
But Ruse noted that emergency contraceptives have 11 different modes of action on a woman'd reproductive system. Five of them are contraceptive and could prevent the union of egg and sperm. Six of them are abortifacient and create an artificial hormonal environment inside a woman'd body that is hostile to a new embryo and causes it to abort.
The abortifacient nature of the drug prompted the bishops’ conference to issue a letter to the FDA'd Nonprescription Drugs Advisory Committee and the Advisory Committee on Reproductive Health objecting to the proposal to make the “morning-after pill” available over the counter. They argued it would “conflict with a trend in law and medicine that recognizes the human embryo as a human subject and a patient deserving protection.”
But the bishops are not solely concerned with the immorality of emergency contraception. They noted that it poses significant health risks, especially increased risk of ectopic pregnancy, a potentially fatal condition in which a baby begins to develop in the fallopian tubes rather than the uterus.
Medical Mission Sister Hanna Klaus, an obstetrician and gynecologist from the Natural Family Planning Center of Washington, D.C., one of about 40 presenters to the advisory committees, presented data that supported the bishops’ position.
She said the U.K. Committee on Safety in Medicines issued a warning, echoed by New Zealand'd public health system, after it discovered that 5.9% of unintended pregnancies were ectopic after taking emergency contraception.
“To make a drug that has the potential of increasing the rate of ectopic pregnancy fivefold available without medical supervision is the height of medical irresponsibility,” Sister Klaus said.
Sister Klaus also cited increased rates of sexually transmitted diseases in America, including a 20% increase in the incidence of chlamydia in the state of Washington since 1998 when Plan B was made available over the counter there.
Another presenter, Wendy Wright of Concerned Women for America, criticized the lack of study on long-term effects and multiple use of emergency contraception.
She hopes the plan to make the drug available over the counter can be prevented by a new law signed by President Bush on Dec. 3. The Pediatric Research Equity Act, with bipartisan support and endorsed by Sen. Hillary Clinton, D-N.Y., would require that the drugs be tested on children and adolescents before it is marketed to them — something that was not done with PlanB.
In reply, Dr. Sandra Kweter, the FDA'd deputy director for new drugs, remarked that the agency, when it comes to contraception, makes no distinction between youths and adults.
“If preteens can get pregnant, physically, they are the same as adults,” Kweter said at the hearing.
But Dr. David Hager, a member of the Advisory Committee on Reproductive Health who was pilloried for his pro-life views when he was appointed by President Bush last year, disagreed.
He told the Register he voted against the proposal because of his concerns about the “lack of adequate long-term follow-up” and the lack of age restrictions on the drug. If it were to be freely available over the counter, teens and preteens, who would be least likely to understand complications of the drug, would be taking it without medical oversight or parental knowledge.
Hager cited the FDA'd own data from a study of 656 adult women who took emergency contraception.
“Fully one-third of them did not understand that the drug was to be taken only in an emergency and they were confusing it with regular contraceptives,” Hager said.
Among the “low literacy” group of adults, only 46% understood it was not for repeated use. One-quarter of all the women in the study did not understand they should go to a doctor if they experienced persistent abdominal pain — a sign of ectopic pregnancy.
The chairman of the Nonprescription Drugs Advisory Committee, Louis Cantalina, also voted against the proposal, citing the FDA study as a “failure” and the literacy levels for understanding complications of the drug as “horrible.”
But a majority of presenters and panel members clearly viewed doctors, parents and even pharmacists as barriers between women and the drug.
Dr. Vivian Dickerson, presidentelect of the American College of Obstetricians and Gynecologists, urged panelists to support “a public health imperative to increase access to emergency contraception.”
Several members of the National Organization for Women — including one who said she had taken emergency contraception on six different occasions — testified that they took the drug after a condom broke but that it was not conveniently available.
A representative of Barr Laboratories, the Pomona, N.Y.-based company that is currently acquiring the rights to distribute Plan B from the Women'd Capital Corp., said the company intends to curb repeated use of the drug by making it costly — about $30 per use.
At the end of the day panelists voted 23-4 in favor of making the drug available over the counter. The FDA is expected to decide whether to follow the vote sometime in February.
Celeste McGovern writes from Victoria, British Columbia.
- January 4-10, 2004