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29 August, 2005: Morning after pills side effects did not seem to be the prime reason why the Unites States FDA did not the give the go-ahead for the morning after pill "Plan B" manufactured by Barr Pharma, which is currently a prescription drug in the US.
"Plan B", more popularly known as the "Morning-after pill" or "emergency contraceptive", is used to prevent unwanted pregnancy following unprotected sex. Unlike ordinary contraceptives, it is taken within three days (72 hours) of sex. It contains large doses of levonorgestrel, triggering fears of hormonal side-effects. Unlike many other pre-sex contraceptives, it does not contain estrogen. However, the potential risk or side effects of the emergency abortion pill Plan B did not seem to be the reason why the authorities did not given the go-ahead to put it for over-the-counter sales.
According to FDA commissioner Lester Crawford, "There are unique regulatory issues that need to be addressed, and we have decided we can only make these decisions in an open public process." FDA has deferred decision on putting the morning-after pill for OTC sales by another 60 days, to seek public comments and opinion in the regard.
There are other issues to be solved too. Barr Pharma, which manufacturers the morning-after pill, wants the emergency contraceptive to be made available for women from 16 years and above, whereas the Center for Drug Evaluation and Research has recommended the age of 17. The medical authorities are still trying to figure out how an age bar can be enforced, and whether such a limit is required at all.
Morning-after pill Plan B may still get a dual labeling - which means it could be sold a prescription drug and for over-the-counter sales.
Said Mr Crawford: "We need to resolve these policy and regulatory questions before we can reach a final decision on the underlying science that was presented to us."
FDA seems reasonably confident that the morning-after pills side effects are nil: which is why the drug continues to be sold as a prescription drug, even as the final decision on the over-the-counter status of the emergency contraceptive hangs fire.
According to the Plan B drug website, the emergency contraceptive pill drug acts best, if it is taken at the earliest. It does not protect against AIDS or any other venereal diseases.
The makers of the morning after pill are clearly disappointed. In a press release, Barr Labs said that it had clearly asked for dual labeling for Plan B, supporting which it had given detailed legal analysis. The company also said that even though it is not happy with the FDA decision, it will use the next 60 days to continue pushing for OTC status for the emergency contraceptive.
Used within 72 hours, Plan B reduces the risk of pregnancy by 89%, Barr Labs claimed in a press release. It performs best when consumed within 24 hours. Barr said that declining efficiency as time proceeds is the prime reason why the morning-after pill should be put on the counter, to ensure timely and easy access to Plan B.
Emergency contraception, said Barr, is currently available in 104 countries, out which 34 countries sell the medicine over-the-counter.
The company, in its mandatory sub-heading for Plan B contraindications said that progestin-only contraceptive pills (POP) are not supposed to be used in cases of known or suspected pregnancy, allergy to any components of the drug or abnormal genital bleeding.
BY OUR PHARMA CORRESPONDENT
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