/PRNewswire / -- Moira Gaul, Family Research Council's Director of Women's and Reproductive Health, released the following statement regarding the Obama Administration's decision to sell the morning-after-pill to 17-year-olds without a prescription.
"The Obama Administration is permitting a judge to make a scientific decision as to the safety of the over-the-counter sale of Plan B. This decision places policy preferences before safety. The best interest of women's health is not advanced by these decisions. Reason, science, and compassion clearly are not the animating factors of the decision.
"In order for a drug to be sold over-the-counter, patients must be able to safely medicate themselves without medical supervision. Studies tracking the label comprehension for Plan B show poor awareness that Plan B is not a substitute for standard contraceptives. The FDA-approved label for Plan B gives no clear indication that repeated use of Plan B in a short period of time is not safe.
"FDA officials understood these safety concerns in 2006 and were not convinced that the label comprehension data for teens demonstrated that they could use Plan B safely. The FDA officials believed more data needed to be submitted.
"There is a real danger that Plan B may be given to women, especially sexually abused women and minors, under coercion or without their consent. Interaction with medical professionals is a major screening and defense mechanism for victims of sexual abuse. The availability of Plan B over-the-counter also bypasses the necessary routine medical care of sexually active girls and women, which is important for the screening of health conditions, and for providing screening for sexually transmitted diseases."
Showing posts with label over the counter. Show all posts
Showing posts with label over the counter. Show all posts
Thursday, April 23, 2009
Wednesday, April 22, 2009
Americans United for Life Condemns FDA Decision that Will Increase Minors' Access to Plan B
/PRNewswire / -- The Food and Drug Administration (FDA) today announced that it will not appeal a U.S. District Court order that 17-year-old girls should have unrestricted, over-the-counter access to Plan B or so-called "emergency contraception."
Dr. Charmaine Yoest, President & CEO of Americans United for Life said, "The federal agency tasked with protecting public health has abdicated its responsibility by not appealing the court order. The maker of Plan B has not researched what happens when adolescents take Plan B. In addition, neither the maximum safe dose nor the effects of overdose have been determined by scientific study on any age group."
Last month, the U.S. District Court for the Eastern District of New York in Tummino v. Torti ordered the FDA to make Plan B available to 17-year-olds under the same conditions that it is currently available to adult women. This overruled a previous decision by the FDA requiring that minors first obtain a valid prescription for the potentially dangerous drug.
In addition, the court's ruling did not permit the FDA to undertake another internal review of the drug's safety record or to receive evidence on the increased need to protect minors from dangerous medications or even sexual abuse.
Denise Burke, AUL Vice President of Legal Affairs said, "With this decision, an unsafe drug could be used by sexual predators and even the victims themselves to hide the abuse from parents and the authorities."
For more on the safety concerns surrounding Plan B, see "The Deadly Convenience Of RU-486 and Plan B" in AUL's annual legal guide Defending Life 2009.
Dr. Charmaine Yoest, President & CEO of Americans United for Life said, "The federal agency tasked with protecting public health has abdicated its responsibility by not appealing the court order. The maker of Plan B has not researched what happens when adolescents take Plan B. In addition, neither the maximum safe dose nor the effects of overdose have been determined by scientific study on any age group."
Last month, the U.S. District Court for the Eastern District of New York in Tummino v. Torti ordered the FDA to make Plan B available to 17-year-olds under the same conditions that it is currently available to adult women. This overruled a previous decision by the FDA requiring that minors first obtain a valid prescription for the potentially dangerous drug.
In addition, the court's ruling did not permit the FDA to undertake another internal review of the drug's safety record or to receive evidence on the increased need to protect minors from dangerous medications or even sexual abuse.
Denise Burke, AUL Vice President of Legal Affairs said, "With this decision, an unsafe drug could be used by sexual predators and even the victims themselves to hide the abuse from parents and the authorities."
For more on the safety concerns surrounding Plan B, see "The Deadly Convenience Of RU-486 and Plan B" in AUL's annual legal guide Defending Life 2009.
Monday, March 23, 2009
U.S. District Court Finds the FDA's Actions on Plan B(R) Tainted by Politics
/PRNewswire/ -- Today a U.S. District Court ruled that the Food and Drug Administration (FDA) allowed politics to taint their decision to make Plan B(R) available over-the-counter (OTC) for individuals age 18 and older. The judge recognized that the FDA gave into political pressure and did not rely on the sound science that supported making Plan B available without a prescription for all age groups. Calling the FDA's procedure for approving the drug "capricious" and "arbitrary," the court ordered the FDA to reconsider its decisions regarding the Plan B switch to OTC use and ordered the FDA to permit Plan B's availability to 17 year olds without a prescription beginning in 30 days.
"This ruling validates what we have known all along - politicians trumped the scientists when it came to the FDA's handling of Plan B," said Kirsten Moore, President and CEO of the Reproductive Health Technologies Project. "Plan B is a safe and effective back-up contraceptive method that gives women of all ages an option to prevent unintended pregnancy. We urge the FDA and Duramed to work together to lift the unnecessary age restriction and put Plan B on pharmacy shelves to make timely access a reality for anyone who needs it."
This ruling comes in response to a lawsuit filed by the Center for Reproductive Rights against the FDA for its failure to make emergency contraception Plan B available over-the-counter. The lawsuit claimed that the FDA broke its own rules and regulations, ignored medical consensus, as well as the expertise of its own scientists and advisory committees by holding Plan B to an arbitrarily higher standard than other OTC products. The plaintiffs asked the court to order the FDA to make Plan B available over-the-counter for women of all ages.
Plan B is an FDA-approved, back-up birth control method that can prevent pregnancy in the first few days after sex. Containing a concentrated dose of the progestin hormone found in daily birth control pills, Plan B can reduce the risk of pregnancy by up to 89 percent when taken within 72 hours of sexual intercourse (the sooner a woman takes it, the more effective it is). Critics have argued that increased access to Plan B would lead to promiscuity or other risky health behaviors but these concerns are misplaced. Real world experience with EC and other contraceptives show that reducing barriers to access is important but not sufficient when it comes to reducing unintended pregnancy. Access must be coupled with information and education to help individuals make healthy choices throughout their lifetime.
"This ruling validates what we have known all along - politicians trumped the scientists when it came to the FDA's handling of Plan B," said Kirsten Moore, President and CEO of the Reproductive Health Technologies Project. "Plan B is a safe and effective back-up contraceptive method that gives women of all ages an option to prevent unintended pregnancy. We urge the FDA and Duramed to work together to lift the unnecessary age restriction and put Plan B on pharmacy shelves to make timely access a reality for anyone who needs it."
This ruling comes in response to a lawsuit filed by the Center for Reproductive Rights against the FDA for its failure to make emergency contraception Plan B available over-the-counter. The lawsuit claimed that the FDA broke its own rules and regulations, ignored medical consensus, as well as the expertise of its own scientists and advisory committees by holding Plan B to an arbitrarily higher standard than other OTC products. The plaintiffs asked the court to order the FDA to make Plan B available over-the-counter for women of all ages.
Plan B is an FDA-approved, back-up birth control method that can prevent pregnancy in the first few days after sex. Containing a concentrated dose of the progestin hormone found in daily birth control pills, Plan B can reduce the risk of pregnancy by up to 89 percent when taken within 72 hours of sexual intercourse (the sooner a woman takes it, the more effective it is). Critics have argued that increased access to Plan B would lead to promiscuity or other risky health behaviors but these concerns are misplaced. Real world experience with EC and other contraceptives show that reducing barriers to access is important but not sufficient when it comes to reducing unintended pregnancy. Access must be coupled with information and education to help individuals make healthy choices throughout their lifetime.
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