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Coalition of medical professionals and family groups ask court to reverse FDA's decision

FDA sued over unlawful approval of morning-after pill...

LifeSiteNews reported on April 16, 2007:

A lawsuit was filed April 12 in Federal Court seeking to overturn the Food and Drug Administration's (FDA) unprecedented approval of the morning-after pill, Plan B, as both non-prescription and prescription based on the age of the buyer.

The lawsuit was brought by the American Association of Physicians and Surgeons (AAPS), Concerned Women for America (CWA), Family Research Council (FRC) and Safe Drugs for Women. The suit argues that the FDA committed numerous violations to approve the drug due to extreme political pressure exerted specifically by Senators Hillary Clinton (D-NY) and Patty Murray (D-WA).

CWA President Wendy Wright said, "The FDA buckled to pressure to do something it has never done before - make a high dose of a drug available without a prescription when a low dose of the same drug requires a prescription. The agency skirted laws and regulations put in place to ensure drugs are safe and effective, relenting under undue pressure from political operatives."

The lawsuit makes the case that:

- The data submitted by Plan B's owner did not establish that it is safe or effective. The owner did not test the effects of taking a high dose of hormones during puberty. The FDA did not consider the safety effects on women of all ages, missing medical checkups and counseling that is necessary for the conditions in which Plan B is used. It misleads consumers regarding Plan B's efficacy, leading to unintended pregnancies.

- The trials to test how well consumers understood the label directions showed that consumers do not understand it well enough to self-medicate with Plan B. Fully one-third of women of all ages did not understand that Plan B cannot be used as a regular form of birth control. The label is misleading and does not provide the legally required disclaimers to delineate what it can and cannot do. This makes Plan B particularly unsafe for young women and girls because they do not understand that Plan B does not replace traditional and more effective birth control, and they may take it too often.

- The FDA lacks authority to approve the same drug for both over-the-counter (OTC) and prescription-only distribution.

- The FDA lacks authority to approve distribution based on the buyer's age.

- The FDA lacks authority to approve "behind-the- counter" - a drug that is neither fully OTC nor prescription only.

- The FDA approved Plan B for non-prescription use without conducting the necessary rulemaking required by the Administrative Procedure Act and the Federal Food, Drug and Cosmetic Act.

- The sudden reversal by FDA and Commissioner von Eschenbach had the distinct appearance of resulting from improper political pressure exerted by Senators Clinton and Murray who made clear that they put "holds" on von Eschenbach's confirmation until he acted on Plan B.

- The FDA's approval ensures that girls will have unsupervised access to Plan B even though FDA has found that Plan B is unsafe for girls without medical supervision, as denoted by the fact it is prescription- only for those under 18.

- The FDA failed to require Plan B's owner to comply with the Pediatric Research Equity Act which protects children and adolescents.

This lawsuit seeks to reverse the FDA's decision, placing Plan B back where it belongs: as prescription- only. Barring that, the suit seeks to require a rulemaking procedure to address the legal questions raised.

"The encyclical of Pope Paul VI on birth control is true and must be followed by mankind. There shall be no rationalization of sin.” - Our Lady of the Roses, October 2, 1976

“Permissiveness shall not be accepted by your God. Sin is sin; there is no compromise for sin. Mortal sin is a grievous offense to the Eternal Father. The Commandments shall be followed without permissiveness.” – Jesus, November 21, 1977

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The awesome Bayside Prophecies...  http://www.tldm.org/Bayside/default.htm  
These prophecies came from Jesus, Mary, and the saints to Veronica Lueken at Bayside, NY, from 1968 to 1995:

SIXTY MILLION
"I say this for this reason: the Eternal Father is much disturbed at the numbers of abortions being committed throughout your country and the world. These numbers go upwards to fifty to sixty million in one year throughout the world." - Our Lady, June 18, 1986

TREATED AS GARBAGE
"O My child, My tears fall upon you all when I see all of the innocent little babies being slaughtered . . . cast into garbage pails like nothing but dirt and scum. They are living human beings! And all murderers shall get their just recompense." - Our Lady, March 18, 1983

DOCTORS
"Doctors now are profaning their profession, those who have given themselves over to destroying human life in abortions." - Jesus, June 6, 1987

FOULEST OF DEEDS
"Our hearts are torn because of the wanton murder of the young by evil man. Abortion, My children, is murder, the most foulest of deeds, that is punishable by death! And what is worse than death of the soul?
     "I say unto you, as your Mother, that any man or woman who performs or takes part of this abomination of the murder of the unborn shall be given a heavy penance upon earth, or if this penance is not given upon earth, that person found guilty in the eyes of his God shall suffer eternal damnation in the fires of hell." - Our Lady, December 28, 1976 

TORMENT
"The torment that will be visited upon those who murder the innocent shall be eternal damnation and feasting their eyes upon the murdered souls." - Our Lady, May 10, 1972

SAINTS CRY OUT FOR PUNISHMENT
"Oh, the greatest of sorrow is upon Our hearts because of the loss of the little ones. Your country, My child, and many countries throughout your world, shall do great penance for the murders of the young, the abortions, the murders being committed in your country. The saints in Heaven cry out for punishment upon a wicked generation. Never in the past, in all the slaughters of history, has there been such wanton killing of the young and the innocent! I say unto you, as your God, you shall be brought down to your knees! You, evil mankind, you shall be cleansed in a bloodbath!” - Jesus, February 1, 1977

Directives from Heaven... http://www.tldm.org/directives/directives.htm

D23 - Abortion PDF
D28 - Hell  PDF
D183 - Sex Education    PDF
D196 - Life Begins at Conception    PDF

Articles…

Outside Links…

Contraception:

Contraception: Fatal to the Faith and to Eternal Life,  John A. Hardon, S.J.

Is Contraception Gravely Sinful Matter? by Fr Lino Ciccone CM (from L'Osservatore Romano, 4 December 1996)

Faithfulness to the Divine Plan in the Transmission of Life Pope John Paul II's General Audience (8 August 1984)

Humanae Vitae Pope Paul VI - Encyclical - On the Regulation of Births (25 July 1968)

Contraception Versus Abortion: A Comparison and Some Implications, By Msgr. Vincent Foy, PhD.

Contraception and Catholic Teaching, Donald DeMarco, Ph.D.

God and the Pill, Terence J. Hughes

Abortifacients, Charles M. Mangan

Abortion:

Sin to vote for pro-abortion politicians? Fr. Matthew Habiger
http://www.ewtn.com/library/ISSUES/SINTOVOT.HTM

“Whoever is not with Me, is against Me,” Archbishop William Levada
http://www.ewtn.com/library/BISHOPS/LEVADA.HTM

Declaration on procured abortion (CDF, November 18, 1974)
http://www.ewtn.com/library/CURIA/CDFABORT.HTM

The Gospel of Life, Pope John Paul II, March 25, 1995
http://www.ewtn.com/library/ENCYC/JP2EVANG.HTM

We encourage everyone to print or email copies of this web page to all the Bishops and all the clergy.  Also, email or send this web page to the news media and as many people as possible.

Crucifix on front and back door...  The only real protection against terrorists...
Jesus - "Pray and wear your sacramentals. And, also, My children, I ask you again to place a crucifix upon your door. Both front and back doors must have a crucifix. I say this to you because there will be carnage within your areas, and this will pass you by if you keep your crucifix upon your doors." (6-30-84) (Testimonies of lives and homes saved by the crucifixes.)  http://www.tldm.org/news/crucifix.htm 

Heaven’s Home Protection Packet...
Our Lord stated we must have crucifixes upon the outside of all of our outside doors. In the "Heaven’s Home Protection Packet" there are instructions, four crucifixes, and a tube of special cement for wooden or metal crucifixes. Wooden crucifixes adhere better to the doors when the aluminum strap is removed from the back. Put a light coat of cement on the back of the crucifix and then press it to the outside of the door. If you have any problems, you can call us at 616-698-6448 for assistance. This Heaven’s Home Protection Packet is available for a donation of $5.00 plus $3.00 shipping and handling. Send $8.00 to TLD Ministries, P.O. Box 40, Lowell, MI 49331. Item # P15  (Order Form)

Incredible Bayside Prophecies on the United States and Canada book . . .
We have researched the Bayside Prophecies on the United States and Canada and put these outstanding prophecies in a 360 page pocket size paperback book.   Veronica said it was very good.  It tells what is going to happen here and how to prepare for it.  Every North American must read this book!  Item #B2 Cost $5.00 (Order Form)

"My children, My little humble children, I appeal to you as your Mother, go forward on foot, knock on the doors; bring the light to your brothers and sisters.  For those who have been given great grace, much is expected of them." - Our Lady of the Roses,  May 26, 1976

"As disciples of the latter days, My children, much shall be asked of you, but I assure you:  all that you give in faith and charity shall be returned to you threefold." - Jesus, June 1, 1978