WP: FDA Delays Morning-After Pill Decision

[Ignatius J.]

This seems crazy to me. Allowing this drug to teenagers would help prevent teen pregnancies. I understand that it seems like encouraging kids to have sex, but I'd bet that over the long haul fewer pregnant teenagers means fewer bad parents which means fewer messed up kids who tun into pregnant teenagers.

http://www.washingtonpost.com/wp-dyn/content/article/2005/08/26/AR2005082601192.html

FDA Delays Morning-After Pill Decision

By LAURAN NEERGAARD

The Associated Press

Friday, August 26, 2005; 5:33 PM

WASHINGTON -- The government on Friday put off its long-awaited final decision on whether to sell emergency contraception without a prescription, saying the pill was safe to sell over-the-counter to adults but grappling with how to keep it out of the hands of young teenagers.

In a surprise move, the Food and Drug Administration postponed for at least 60 days a final decision on how to allow nonprescription sales of the morning-after pill called Plan B just to women 17 or older.

"Enforceability is the key question," said FDA Commissioner Lester Crawford.

The drug's maker, Barr Pharmaceuticals, criticized the decision, questioning how the agency could acknowledge that scientific evidence supported nonprescription sales and yet not allow those sales to begin.

"It's like being in purgatory," said Barr chief executive Bruce Downey.

The morning-after pill is a high dose of regular birth control that, taken within 72 hours of unprotected sex, can lower the risk of pregnancy by up to 89 percent.

It was Barr's latest disappointment in the two-year battle to sell Plan B without a prescription. Contraceptive advocates and doctors groups say easier access could halve the nation's 3 million annual unintended pregnancies. FDA's scientists say the pills are safe, used by more than 2.4 million Americans and millions more women abroad with few side effects.

The agency's independent scientific advisers overwhelmingly backed over-the-counter sales for everybody, not just adults, in December 2003.

FDA rejected that recommendation, citing concern about young teens' use of the pills without a doctor's guidance. Barr reapplied, asking that women 16 and older be allowed to buy Plan B without a prescription while younger teens continue to get a doctor's note. Downey said the company thought it had satisfied all of FDA's scientific and legal concerns about how to do that _ noting that cigarettes are sold in drugstores with age restrictions.

Friday, FDA essentially boiled the issue down to regulatory precedent: Selling the same dose of a drug by prescription and without at the same time and for the same medical use has never been done. The FDA will allow 60 days of public comment on how to take such a step and enforce an age limit, but Crawford would not say how soon the agency could evaluate those comments and rule.

Contraceptive advocates had expected a final decision by a Sept. 1 deadline that Crawford had pledged to members of Congress as a condition of assuming leadership of FDA.

"I am disappointed that FDA waited until this late hour to address a legal question that could and should have been resolved months ago," said Sen. Edward Kennedy, D-Mass. "I urge FDA to act quickly to approve this needed reproductive option for women."

"It seems improbable to me that ... politics hasn't trumped science here, which is a tragedy," said Dr. Alastair Wood of Vanderbilt University, who chaired the FDA advisory committee that evaluated Plan B.

"They are acting in bad faith," said Kirsten Moore of the Reproductive Health Technologies Project, noting that FDA already has logged 17,400 letters from the public and advocacy groups urging it to take one side or the other on Plan B. "How many more comments do they need?"

Conservative groups, which have intensely lobbied FDA arguing that over-the-counter emergency contraception would encourage teen sex, welcomed the agency's decision.

"It is naive to assume any over-the-counter scheme for the morning-after pill would be effective," said Wendy Wright of Concerned Women for America. "Making the morning-after pill over-the-counter would only benefit those that profit from its increased sale, but the real price will be paid by women and girls who would suffer the health consequences."

If a woman already is pregnant, the pills have no effect. They prevent ovulation or fertilization of an egg. They also may prevent the egg from implanting into the uterus, the medical definition of pregnancy, although recent research suggests that's not likely.

Laws in seven states _ Alaska, California, Hawaii, Maine, New Hampshire, New Mexico and Washington _ already allow women to buy Plan B without a prescription, with no age restrictions. Massachusetts is set to become the eighth this fall, as lawmakers are expected to override their governor's veto of nonprescription sales.

© 2005 The Associated Press

[SnyderShrugged]

I think this is my most controversial opinion...

The FDA should not exist (at least funded by tax payers).

[DarkLadyRaven]

I think this is my most controversial opinion...

The FDA should not exist (at least funded by tax payers).

I guess you have never read Upton Sinclairs : The Jungle?

If we let american companies run the whole shabang- they would just push out foreign companies medical projects

[Larry]

I think this is my most controversial opinion...

The FDA should not exist (at least funded by tax payers).

I think it's a good idea to have some regulatory agency.

Now, a case could be made, for example, that Underwriters Laboratories has done a very good job of keeping our electrical system safe without (AFAIK) the government being involved, other than to pass laws that require electrical devices to be UL approved.

(I think, based on their name, that UL was started by a group of insurance companies, who certainly had a vested interest in preventing electrical fires.)

(IMO, if you want a preview of a world without the FDA, walk into any "suplement" store, where, I suspect, a minimum-wage High School dropout (in a white coat with a stethescope) will tell you that if you take 7,000 times the recommended dose of Vitamin C, it will render you immune to the common cold. But who will swear that his pills are not sold to cure or prevent any disease, and that the employees aren't practicing medicine.)

[Larry]

(BTW, anybody see irony in delaying a decision on a morning-after contraceptive?)

[SnyderShrugged]

I guess you have never read Upton Sinclairs : The Jungle?

If we let american companies run the whole shabang- they would just push out foreign companies medical projects

Who do you think runs it now?

Who does the actual testing for the FDA now?

[DarkLadyRaven]

Who do you think runs it now?

Who does the actual testing for the FDA now?

The employees of the FDA inspect the different grades of meat and enforce set standards upon the industry from the killing floor.