/PRNewswire / -- The Food and Drug Administration (FDA) announced late on April 22 that it has expanded over-the-counter access to the morning-after pill, Levonorgestrel or "Plan B," for 17-year-old minors as well as to adults. Deirdre McQuade, Assistant Director for Policy and Communications at the U.S. Conference of Catholic Bishops' Secretariat of Pro-Life Activities, objected to the move in the following statement:
"The FDA's court-driven decision to make Plan B available without a prescription to 17-year-old minors - as well as to adults - flies in the face of common sense. Levonorgestrel is a powerful drug, taken in two doses over a 12-hour period. It is 40 times more potent than comparable progestin-only birth control pills (Ovrette) for which a prescription is required.
"Wider access to Plan B could endanger the lives of newly-conceived children, and will put minors at risk for unnecessary side effects, undermine parental rights, and contribute to higher STD rates.
"Pregnancy is not a disease and fertility is not a pathological condition, so Plan B has no authentic therapeutic purpose, and can actually cause harm to women and their newly-conceived children.
"The FDA describes Plan B as 'a contraceptive drug.' Although Plan B can prevent fertilization, the manufacturer admits it may also prevent an embryo from implanting in the womb, which is essential to his or her continued survival. Since it takes several days for the growing embryo to reach the uterine lining and implant in the mother's womb, the child in his or her second week of life could die as a direct result of Plan B. This is properly understood as an early abortion.
"Without the benefit of a doctor's supervision, many teens will be unaware of this possible abortifacient action and the other risks posed by Levonorgestrel, particularly the risks from repeated use.
"Much to the surprise of the morning-after pill's early advocates, five years of research in Europe and the U.S. shows that increased access to emergency contraception has failed to reduce rates of unintended pregnancy and abortion. But it has led to greater sexual risk-taking among adolescent populations, in turn leading to higher rates of sexually-transmitted disease. In the unlikely event a teenager will bother to read the Plan B package insert all the way to the end, she will find sound advice: 'Of course, not having sex is the most effective way to prevent pregnancy and stay free of STDs'."
Showing posts with label fda. Show all posts
Showing posts with label fda. 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.
Thursday, March 5, 2009
House Committee Vote Sets Congress on Course for Historic Regulation of Tobacco Products
/PRNewswire-USNewswire/ -- The following is a statement by Matthew L. Myers, President, Campaign for Tobacco-Free Kids:
The House Energy and Commerce Committee today set Congress on a course to take truly historic action to reduce tobacco use by approving legislation granting the U.S. Food and Drug Administration authority over tobacco products. Today's 39-13 vote underscores the broad, bipartisan support for this legislation. Coming early in the new Congress, it sends a powerful signal that this year Congress will finally enact into law this long-overdue legislation to protect our children from tobacco addiction and save lives. Few actions would make a bigger difference for our nation's health than the regulation of tobacco products, the number one cause of preventable death in the United States.
We applaud House Energy and Commerce Committee Chairman Henry Waxman (D-CA) and Representative Todd Platts (R-PA) for their leadership in introducing this strong legislation and quickly moving it forward. Enactment of this legislation into law would represent a tremendous victory for America's health and a bipartisan achievement for the new Congress and President Obama, who co-sponsored the bill while a senator.
This legislation has strong, bipartisan support across the nation and in Congress. It has been endorsed by more than 950 public health, faith, medical and other organizations (see list at www.tobaccofreekids.org/reports/fda/organizations.pdf). A poll last year found that FDA regulation of tobacco products is supported by 70 percent of American voters (see details at www.tobaccofreekids.org/fdapoll/). It has been endorsed by scientific authorities including the Institute of Medicine and the President's Cancer Panel. The House of Representatives in July approved the legislation by an overwhelming vote of 326 to 102, and it had 60 Senate sponsors in the last Congress.
This legislation is urgently needed. Tobacco use kills more than 400,000 Americans and costs the nation $96 billion in health care bills each year. Every day, another 1,200 Americans die from tobacco use and another 1,000 children become new regular smokers. Yet tobacco products are virtually unregulated to protect public health. This lack of regulation allows tobacco companies to market their deadly and addictive products to children, deceive consumers about the harm their products cause, make changes to their products without disclosing them (such as manipulating nicotine levels in cigarettes) and resist any meaningful change to make their products less harmful.
This legislation would grant the FDA the authority and resources to effectively regulate the manufacturing, marketing and sale of tobacco products. Among other things, it would:
-- Restrict tobacco advertising and promotions, especially to children.
-- Stop illegal sales of tobacco products to children.
-- Require larger, more effective health warnings on tobacco packages and
advertising.
-- Ban misleading health claims such as "light" and "low-tar" and
strictly regulate all health claims about tobacco products to ensure
they are scientifically proven and do not discourage current tobacco
users from quitting or encourage new users to start.
-- Require tobacco companies to disclose the contents of tobacco
products, as well as changes in products and research about their
health effects.
-- Empower the FDA to require changes in tobacco products, such as the
removal or reduction of harmful ingredients or the reduction of
nicotine levels.
We urge both the House and the Senate to quickly enact this legislation into law and to resist all efforts to weaken it.
The House Energy and Commerce Committee today set Congress on a course to take truly historic action to reduce tobacco use by approving legislation granting the U.S. Food and Drug Administration authority over tobacco products. Today's 39-13 vote underscores the broad, bipartisan support for this legislation. Coming early in the new Congress, it sends a powerful signal that this year Congress will finally enact into law this long-overdue legislation to protect our children from tobacco addiction and save lives. Few actions would make a bigger difference for our nation's health than the regulation of tobacco products, the number one cause of preventable death in the United States.
We applaud House Energy and Commerce Committee Chairman Henry Waxman (D-CA) and Representative Todd Platts (R-PA) for their leadership in introducing this strong legislation and quickly moving it forward. Enactment of this legislation into law would represent a tremendous victory for America's health and a bipartisan achievement for the new Congress and President Obama, who co-sponsored the bill while a senator.
This legislation has strong, bipartisan support across the nation and in Congress. It has been endorsed by more than 950 public health, faith, medical and other organizations (see list at www.tobaccofreekids.org/reports/fda/organizations.pdf). A poll last year found that FDA regulation of tobacco products is supported by 70 percent of American voters (see details at www.tobaccofreekids.org/fdapoll/). It has been endorsed by scientific authorities including the Institute of Medicine and the President's Cancer Panel. The House of Representatives in July approved the legislation by an overwhelming vote of 326 to 102, and it had 60 Senate sponsors in the last Congress.
This legislation is urgently needed. Tobacco use kills more than 400,000 Americans and costs the nation $96 billion in health care bills each year. Every day, another 1,200 Americans die from tobacco use and another 1,000 children become new regular smokers. Yet tobacco products are virtually unregulated to protect public health. This lack of regulation allows tobacco companies to market their deadly and addictive products to children, deceive consumers about the harm their products cause, make changes to their products without disclosing them (such as manipulating nicotine levels in cigarettes) and resist any meaningful change to make their products less harmful.
This legislation would grant the FDA the authority and resources to effectively regulate the manufacturing, marketing and sale of tobacco products. Among other things, it would:
-- Restrict tobacco advertising and promotions, especially to children.
-- Stop illegal sales of tobacco products to children.
-- Require larger, more effective health warnings on tobacco packages and
advertising.
-- Ban misleading health claims such as "light" and "low-tar" and
strictly regulate all health claims about tobacco products to ensure
they are scientifically proven and do not discourage current tobacco
users from quitting or encourage new users to start.
-- Require tobacco companies to disclose the contents of tobacco
products, as well as changes in products and research about their
health effects.
-- Empower the FDA to require changes in tobacco products, such as the
removal or reduction of harmful ingredients or the reduction of
nicotine levels.
We urge both the House and the Senate to quickly enact this legislation into law and to resist all efforts to weaken it.
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