FDA Defers Decision on Plan B OTC Application

[Caverject]

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I thought for sure the FDA would make a decision based on scientific evidence. Apperently, this is not the case. Holding public comments is basically inviting politics into the matter. What a bunch of bullshi+!


FDA Defers Decision on Plan B Over-the-Counter Application
Agency to Initiate Rulemaking Proceeding on 'Dual Label' Concept
WOODCLIFF LAKE, N.J., Aug. 26 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that it has received a letter from the U.S. Food and Drug Administration (FDA) concerning the Company's Supplemental New Drug Application (sNDA) seeking Over-the-Counter (OTC) status for its Plan B(R) emergency contraceptive product. The letter states that "the Center for Drug Evaluation and Research ... has completed its review of this application, as amended, and has concluded that the available scientific data are sufficient to support the safe use of Plan B as an OTC product ... for women who are 17 years of age and older." Notwithstanding this clear scientific determination, the FDA has delayed any action on the application. Instead, the FDA informed the Company that it intends to seek public comment on issues related to the approval of a product that has OTC status for patients 17 and older and prescription status for patients 16 and under. In its communication with the Company, the FDA did not commit to any timetable for initiating or concluding the rulemaking proceeding.

"We are disappointed that the FDA did not approve our application. In our submission to the FDA we provided a detailed legal analysis supporting approval of a dual label product and continue to believe that a dual label status can and should be approved for Plan B," said Bruce L. Downey, Barr's Chairman and CEO. "While we believe that a delay is not justified, we will use the opportunity presented by the FDA proceedings to continue to press for approval of Plan B as an OTC/Rx Product."

 

[Caverject]

FDA delays decision about morning-after pill

Concerns about teens cited

WASHINGTON (AP) -- 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.

Why an age restriction at all? Crawford said the issue was at what age teens can understand how to use the pills properly.

Contraceptive advocates had expected a final decision by a September 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-Massachusetts. "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, a member of 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?"

Crawford broke a personal pledge to Congress to decide Plan B's fate by September 1, charged two senators who called for congressional hearings into the delay.

"It is a breach of faith," Sens. Patty Murray, D-Washington, and Hillary Rodham Clinton, D-New York, who lifted objections to Crawford assuming leadership of FDA only after his pledge, wrote in a statement. "There is no credible scientific reason to continue to deny increased access to this safe health care option."

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.

 

[bananaface]

Do you think they will just continue to defer this every time it comes up?

 

[All4MyDaughter]

Do you think they will just continue to defer this every time it comes up?

Yes, because the science and research is in support of OTC, but they don't want to upset the religious right. JMO!

 

[gablet]

When it does become OTC, is it going to be held behind the pharmacy counter so that women could be counseled first? I really doubt that most women really know what they are taking. It will just be referred to as the cheap (when compared to getting an abortion weeks later) abortion pill.

As far as making teens more sexually active, I don't agree. Only education and better role models for teens will prevent that. As soon as spoiled sports stars and bratty celebrities stop being seen as role models and are replaced by nobel and pulitzer prize winners, scientists, moral religious leaders and, of course, their parents, teens will see that 15 is too young to have a baby!!!

 

[bananaface]

I'm sure when it goes OTC there will be a fat marketing campaign which clarifies that it is not an abortifacient.

What is friggin sad is that people are all like "teenagers can get ahold of it". Availability of EC doesn't increase sexualy activity. Do members of the religious right really want grandbabies so that their friends and neighbors can see that their little Suzy has been having sex with a boy?

EC is quite an effective tool for prevention of abortion by preventing pregnancy. In WA, 40% of unintended pregnancies end in abortion. It's not a small issue by any means. If people could just get it in their head that being a no-sex extremist is not the best position from which to prevent abortion, society would be alot better off.

 

[Caverject]

well said...I hear there will be a great article about this drug coming out soon that will hopefully clarify things for pharmacists cause many pharmacists consider it an abortion pill!

 

[Trancelucent1]

This is such a shame. I just hope that sometime before or while I'm a pharmacist this becomes OTC. I've had a few friends who've had to use this. Both of them were over 21 and in serious relationships. Why do they always assume the worst case scenario? Did they forget that millions of women take this every year and not all of them are around 16 years of age? I also agree that they're just trying to apease the religious groups. When will these religious groups learn that teaching abstinence doesn't work?

 

[gablet]

This is such a shame. I just hope that sometime before or while I'm a pharmacist this becomes OTC. I've had a few friends who've had to use this. Both of them were over 21 and in serious relationships. Why do they always assume the worst case scenario? Did they forget that millions of women take this every year and not all of them are around 16 years of age? I also agree that they're just trying to apease the religious groups. When will these religious groups learn that teaching abstinence doesn't work?

I agree, but please understand that "these religious groups" are allowed to have their opinion. Sins of the flesh are considered very serious. If you have ever been in the situation of having had sex with someone and regretting it in the morning, you may understand. Now imagine that you are 15 and you were a virgin.

Yes, just promoting abstinence is not realistic, but when you know that birth control pills and other forms of birth control have the potential to simply not let the fertilzed egg (baby) attach to the mother, you now also want to stop what you consider killing a baby.

 

[bananaface]

Yes, just promoting abstinence is not realistic, but when you know that birth control pills and other forms of birth control have the potential to simply not let the fertilzed egg (baby) attach to the mother, you now also want to stop what you consider killing a baby.

Studies show no difference in attachment rate with or without EC. That MOA is theoretical and not observed. I'd say their opinions on the matter are not relevant to the practice of medicine.

 

[Caverject]

Studies show no difference in attachment rate with or without EC.

What study shows that?

 

[bananaface]

What study shows that?

It was part of the curriculum when I took the Washington State Pharmacist's Association's EC Provider Certification course. I'd have to go through my booklet to dig up the reference. It's at work and I won't be back there until Monday.

 

[Glycerin]

An FDA official has quit over the delay.

http://news.yahoo.com/s/ap/20050831/ap_on_go_ca_st_pe/morning_after_pill

 

[ultracet]

An FDA official has quit over the delay.

http://news.yahoo.com/s/ap/20050831/ap_on_go_ca_st_pe/morning_after_pill

hope she had another job lined up... and probably did as it sounds she was close to the contraception advocates...

perhaps it will come back up after the next presidential election

 

[meg]

I don't get the problem...

Showing an ID is good enough for cigarettes, liquor and R rated movies.. but not for birth control?

🙄