FDA: Finding Death Amiable

FDA Eases Limits on Morning-After Pill

Source: Associated Press/AP Online
Publication date: 08-24-2006
By ANDREW BRIDGES

WASHINGTON - Women may buy the morning-after pill without a prescription - but only with proof they're 18 or older, federal health officials decided Thursday. The Food and Drug Administration ruling culminated a contentious three-year effort to ease access to the emergency contraceptive.

Girls 17 and younger still will need a doctor's note to buy the pills, called Plan B, the FDA told manufacturer Barr Pharmaceuticals Inc.

The compromise decision is a partial victory for women's advocacy and medical groups which say eliminating sales restrictions could cut in half the nation's 3 million annual unplanned pregnancies. Opponents have argued that wider access could increase promiscuity.

The long delay had ensnared President Bush's nominee to head the FDA. On Thursday, two senators said they would lift their blockade, making confirmation of Dr. Andrew von Eschenbach as FDA's commissioner likely next month.

The pills are a concentrated dose of the same drug found in many regular birth-control pills. Taken within 72 hours of unprotected sex, a woman can lower the risk of pregnancy by up to 89 percent. If she already is pregnant, the pills have no effect.

The earlier it's taken, the more effective Plan B is. But it can be hard to find a doctor to write a prescription in time, especially on weekends and holidays. Hence the push to allow nonprescription sales.

Barr has said it hopes to begin nonprescription sales of Plan B by the end of the year. The pills will be sold only from behind the counter at pharmacies - so the pharmacist can check photo identification - but not at convenience stores or gas stations.

There isn't enough scientific evidence that young teens can safely use Plan B without a doctor's supervision, von Eschenbach said in a memo.

But Barr did prove that over-the-counter use is safe for older teens and adults - and licensed pharmacies are used to checking for proof of age 18 before selling tobacco and certain other products, von Eschenbach wrote in explaining the agency's age cutoff.

"This approach should help ensure safe and effective use of the product," he concluded.

Plan B's maker was disappointed that FDA imposed the age restriction and pledged to continue working the agency to try to eliminate it.

"While we still feel that Plan B should be available to a broader age group without a prescription, we are pleased that the Agency has determined that Plan B is safe and effective for use by those 18 years of age and older as an over-the-counter product," said Bruce L. Downey, Barr's chairman.

The age restriction remains controversial even inside FDA, agency drugs chief Dr. Steven Galson told The Associated Press Thursday. Galson has acknowledged overruling his staff scientists' opinion in 2004 that nonprescription sales would be safe for all ages.

"Let me be frank, there still are disagreements," Galson said in an interview. "There were disagreements from the first second this application came in the house."

But, "I'm convinced adolescents are a different group, they require special analyses, sometimes special data," he added.

As a condition of approval, Barr agreed to track whether pharmacists are enforcing the age restriction, by, among other things, sending anonymous shoppers to buy Plan B. FDA said Barr is to conduct that formal tracking at least twice in the first year of sales and annually thereafter, and report stores that break the rules to their state pharmacy licensing boards.

But Barr also will conduct a national education campaign to raise awareness of emergency contraception, among both women and health providers.

The two-pill pack of Plan B today costs from $25 to $40; Barr hasn't said if it will raise the price. Planned Parenthood, already a main dispenser of the pills, expects some insurers to continue covering prescription sales for those who seek the drug that way. But which way is cheaper depends on a woman's insurance.

A Barr spokeswoman estimated that pharmacists dispense about 1.5 million packs a year.

Nine states - Washington, California, New Mexico, Alaska, Hawaii, Maine, New Hampshire, Massachusetts and Vermont - already allow women of any age to buy Plan B without a doctor's prescription from certain pharmacies. Proponents of those pharmacy access programs believe that minors won't see any change in those states, because the pharmacist already technically writes a prescription.

The FDA approved prescription-only sales of Plan B in 1999, and the quest to sell nationwide without a doctor's note began in 2003. That year, the agency's independent scientific advisers overwhelmingly backed nonprescription sales for all ages, and FDA's staff scientists agreed.

But higher-ranking officials rejected that decision, citing concern about young teens' use of the pills without a doctor's oversight. Barr reapplied, asking that women 16 and older be allowed to buy Plan B without a prescription. Then, last August, the FDA postponed a final decision indefinitely, saying the agency needed to determine how to enforce those age restrictions.

FDA's handling of Plan B sparked a firestorm: Critics charged that political ideology had trumped science; a reproductive-rights group sued to force FDA to settle the issue; and congressional auditors concluded the agency may have made decisions without reviewing all the evidence.

Still, nationwide nonprescription sales were widely consider a doomed issue until last month, when the FDA reversed itself and said it would reconsider if Barr agreed to an age 18 restriction. That surprise announcement came on the eve of a Senate committee hearing on whether to confirm von Eschenbach as FDA's new head.

On Thursday, Sens. Hillary Rodham Clinton, D-N.Y., and Patty Murray, D-Wash., said they would lift their roadblock to his full Senate confirmation.

"While we urge the FDA to revisit placing age restrictions on the sale of Plan B, it is real progress that millions of American women will now have increased access to emergency contraception," they said in a joint statement.

Proponents hailed the victory but had hoped for more.

"While I am glad that the drumbeat for a return to a science-based FDA has had some positive impact, this decision still represents a compromise, one that could have the unintended consequence of hurting young women's health," said Dr. Susan Wood, who resigned as FDA's women's health chief to protest the agency's 2005 delay.

But opponent Wendy Wright, president of Concerned Women for America, said Plan B's wider availability could give women a false sense of security, since it isn't as effective as regular birth control. Wright also worries that adult men who have sex with minor girls could force the pills upon them.

The FDA said men 18 and older will be able to buy the pills without a prescription.

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On the Net:

Food and Drug Administration: http://www.fda.gov/

Publication date: 08-24-2006
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WTSA 's Editorial Remarks:

Something about the FDA's recent rulings (ie -Ephedra Ban and "Plan B" approvals) smell afoul. Apparently the FDA is friendly towards a product (Plan B) that insures (nearly) a 90% death rate on unborn Americans; yet, Ephedra that "may contribute to the death of its user(s)" [unproved, yet stated by your FDA Dept] is to be taboo and forever banished?!

Instead, the FDA and other Law Administrators should reinforce, yeah even tighten the laws which are still on the "books" which prohibit adultery, sodomy, etc. But instead they have "just turned a blind eye", unheeding immorality's continued movement toward Sodom and Gomorrah since the "free sex" craze of the '60's.
               (See what the LORD God Alighty did against these nations)
"Then the LORD rained upon Sodom and upon Gomorrah brimstone and fire from the LORD out of heaven; and he overthrew those cities, and all the plain, and all the inhabitants of the cities, and that which grew upon the ground." -- Genesis 19:24-25, King James Bible) 

Problem is, our liberal and conservative lawmakers are just as guilty by having had or being currently involved in an "affair" with "some significant other" [let's called it what Jehovah Elohim does: "Adultery", "Chambering", "Uncleanness"; which those who do such things are "Worthy of Death"].

Furthermore: man was originally created to partake of all the herbs of the garden except for one (and Jehovah Elohim did not declare it as being "ma huang", ie-"ephedra") -it was the "tree of the knowledge of good and evil".

Can you think of the first recorded crime that man committed against mankind? ....... Uhhh, he gave his fellow colleague some ephedra?      Wrong! Cain killed his brother Abel.

Now, a bit harder question: what was the next recorded crime against mankind, breaking one of God's laws? ....... Uhhh, pro-lifers staged a protest outside of Cain's office?       Wrong! Cain's great, great, great grandson named Lamech became the first adulterer, because he was the first polygamist.

So, there you are: you can know that the FDA is in keeping with Cain (am I my brother's keeper) and Lamech (embrassing and condoning sexual irresponsibility). 

The "morning-after pill" is just Satan's way of continuing the take the stinger out of that which God Almighty calls "SIN".

When you hear the words: "An Affair", "Morning-After Pills", "Alternate Lifestyles", "A Woman's Choice" (was about to say "lady's" but no whore is to be embellished with such a term of endearment) then know the true meanings behind these terms: sexual crimes and murderous sins.

Let's continue to make "over-the-counter" the power of the Gospel of Jesus Christ.  Jesus, alone, is able to empower every American, and the entire world, to say "no" to the devil's liberal ideology [not that he has any conservative ideology] and "yes" to the will of God...

Romans 16:25-27 -- " Now to him that is of power to stablish you according to my gospel, and the preaching of Jesus Christ, according to the revelation of the mystery, which was kept secret since the world began, but now is made manifest [known], and by the scriptures of the prophets, according to the commandment of the everlasting God, made known to all nations [no one can say: "I didn't know"] for the obedience of the faith: to God only wise, be glory through Jesus Christ for ever. Amen"       -King James Bible

Forget "Plan B", go back to Plan A - which is to obey God's commands.

Planned Parenthood... Lucifer's Al-qaeda against unborn Americans... so far: 40,000,000 potential US soldiers, doctors, lawmakers, workers, teachers, preachers, etc... (especially voters) have been killed since the 1973 (not so) Supreme Court ruled in favor of Roe vs Wade (1973 's 9-1-1).

~T (John 5:24 -KJB)

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Article disclosing the sound mindedness of at least one Fedral Judge in the land: The Honourable Judge Tena Campbell

Contrast the FDA's "logic" in this case versus the "Plan B"...

Judge Rules Against FDA Ban on Ephedra Product More Food Than Drug, She Says

By Mark Thiessen Associated Press Friday, April 15, 2005; Page E05

SALT LAKE CITY, April 14 -- A federal judge Thursday struck down the FDA ban on supplements containing ephedra, the once-popular weight-loss aid that was yanked from the market one year ago after it was linked to dozens of deaths. The judge ruled in favor of a Utah supplement company that challenged the Food and Drug Administration's ban. Nutraceutical International Corp. claimed that ephedra has been safely consumed for hundreds of years. A U.S. district judge struck down the federal ban on ephedra, the weight-loss aid that was removed from the market last year after it was linked to 155 deaths. Nutraceutical, a Utah company that challenged the ban, said in its lawsuit that ephedra "has been safely consumed" for hundreds of years and is a food, not a drug. (Steven Senne -- AP) Free E-mail Newsletters Lean Plate Club See a Sample | Sign Up Now Industry groups said supplements that included ephedra were once used by 12 million people. Last year's ban of ephedra was the first such outlawing of a dietary supplement. Research shows that ephedra -- an amphetamine-like herb -- can speed heart rate and constrict blood vessels even in seemingly healthy people but that it is particularly risky for those with heart disease or high blood pressure or who engage in strenuous exercise. Among the deaths linked to the substance was that of Baltimore Orioles pitching prospect Steve Bechler, who collapsed and died during spring training two years ago. The judge's decision was seen by some anti-ephedra advocates as falling short of an outright reversal of the ban, though a Nutraceutical lawyer declared flatly, "The ban is gone." The company said it is too soon to say whether it will put the product back on shelves. The FDA was evaluating the ruling, but Health and Human Services Department spokesman William Pierce said the agency "made the right decision from the standpoint of science and our statutory authority." He added, "This is exactly when the dietary supplement law should apply." Health officials and Justice Department lawyers are examining the ruling to determine the next step, Pierce said. U.S. District Judge Tena Campbell agreed with Nutraceutical that ephedra was wrongly being regulated by the FDA as a drug and not a food. She said a 1994 federal dietary supplement law places more restrictive rules on the FDA in determining whether to ban foods as opposed to drugs. The judge said the law requires the FDA to prove that a dietary supplement is harmful, rather than requiring the manufacturer to prove it is safe, as is required with drugs. "The [FDA's] statement that a safe level cannot be determined is simply not sufficient to meet the government's burden," Campbell wrote. Her order prevents the FDA from stopping Nutraceutical from selling its product and sends the case back to the FDA for a determination of what are safe and dangerous levels of ephedrine, ephedra's active ingredient. Nutraceutical President Bruce R. Hough said the lawsuit had little to do with ephedra and more to do with forcing the FDA to follow the rules Congress set down for it. "This is a great affirmation for the system, that the court goes back and says, 'This is Congress's intent,' " he said. Ephedra opponents said the language in the order applies to only a specific, lower-dosage segment of the market. The ruling's final page prohibits the FDA from enforcing the ban on Nutraceutical's supplements containing 10 milligrams or less of ephedra. Ten milligrams per day was the dosage of Nutraceutical's products. "No one -- not the FDA, the supplement industry, nor the public -- has been satisfied by how ephedra has been regulated," said Sen. Orrin G. Hatch (R-Utah), who helped write the 1994 law that also deregulated the supplement industry. "Millions of people have used the product with satisfaction, but there is no doubt the product has had some serious problems," he said. Sen. Richard J. Durbin (D-Ill.), a frequent ephedra critic who worked for the ban, said the ruling underlined the need for "a mandatory and uniform system of reporting adverse health events [huh?? "What about Plan B"?]that result from use of certain dietary supplements."
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Washington Post
(4-15-05)