Family Values Group Opposes 'Plan B' Pill
FDA scheduled to make decision about over-the-counter sales on Sep. 1.
As the Food and Drug Administration prepares to announce its decision regarding over-the-counter sales of the “Plan B” morning-after pill, Family PAC Federal has launched a nationwide awareness campaign to warn about the “long list of recommended restrictions and possible dangerous side effects for those women who would take these pills,” according to Executive Director Paul Caprio.
While no serious complications have been associated with the pill, Levonorgestrel - or “Plan B," which contains a double dose of progesterone, the active ingredient in ordinary birth control pills - is known to cause side effects such as nausea, abdominal pain, fatigue, headache, and menstrual changes, according to the product’s website.
Along with the side effects, Caprio is also concerned about “the issue of substituting the morning-after pill for safe sex which can lead to an increase in sexually transmitted diseases as has happened in Britain.”
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Caprio refers to a study recorded in the British Medical Journal revealing that sexually transmitted diseases in Great Britain went up 62 percent between 1997 and 2002. In the report, Dr. Trevor Stammers, a professor in general practice, wrote, “These indices reflect the outcome of years of unprecedented availability of contraception among young people.”
However, that Britain’s increased availability of Plan B led women there to rely on it rather than other birth control methods or contributed to an increase in unprotected sex is contested by a study released last month, which reported that “no significant change occurred in the proportion of women using more reliable methods of contraception, such as the oral contraceptive pill, or in the proportion of women using emergency hormonal contraception more than once during a year.”
The authors of the new study, conducted by researchers at the Imperial College Faculty of Medicine in London and funded by the British Office of National Statistics, concluded that women prefer obtaining emergency contraception over-the-counter rather than from a physician, a find that they said has, “important policy implications.”
“Given the apparent absence of negative consequences, and the fact that many women clearly prefer to buy (emergency contraception) over the counter, our study supports the case for lifting the ban on over-the-counter sales in the United States and other countries,” the authors, led by professor of primary care Azeem Majeed wrote.
An FDA advisory committee voted 24-3 in December 2003 to allow sales of the Plan B drug over the counter, but FDA officials went against the recommendation because Barr Laboratories, maker of the drug, failed to provide sufficient information about its affect on teenagers. Barr submitted a revised application for non-prescription sales, seeking to limit sales of Plan B to women over 16 years of age.
Caprio believes that the current considerations being made about the pill are oriented around politics rather than health.
“This decision is being politically driven by Senator Hillary Clinton and her allies in the abortion on demand groups who forced the Department of Health and Human Services to set a decision date in order to confirm Lewis Crawford as head of the FDA,” said Caprio. “The public health protection of women should be the paramount issue for the FDA on this issue, not Hillary Clinton’s political agenda.”
Caprio’s reference is to a decision made by Sens. Hillary Rodham Clinton’s (D-N.Y.) and Patty Murray’s (D-Wash.) to lift their holds on acting FDA Commissioner Lester Crawford’s nomination after a letter from HHS Secretary Mike Leavitt stated that a decision by the FDA on Barr's revised application will be made by Sept. 1.
"It's imperative to warn the FDA that making the political rather than the sound science decision on over-the-counter sales of "Plan B" will have long term negative health consequences for teenage girls and many other women in America."
