By Peter Sachs
Q: It seems like everyone has an opinion on making it easier to get the Plan B emergency contraceptive. What's really going on with it? -Shayna, Illinois
A: The debate has been going on at several levels, but it picked up steam when the Food and Drug Administration agreed to look again at making it available for over-the-counter uses.
The medication has been available by prescription since 1999 in the United States and in many other countries as well. Plan B, also known as the "morning after pill," works by keeping a fertilized egg from implanting in the uterus after unprotected intercourse, and it must be taken within 72 hours. That means that from a medical definition, Plan B is not a "chemical abortion." It is simply a higher dose of conventional birth control medications. Plan B is different medication from RU-486, a prescription medication that women can take after they know they are pregnant to end the pregnancy.
The controversy has been sparked in part by some conservative and religious groups that see the medication as a form of abortion. Some opponents are also concerned that making Plan B so easily available would make more people think about taking risks when it comes to sex, though the drug's maker said there is no evidence this would happen.
But when it comes to deciding whether or not to switch a medication from prescription to over the counter, pretty much the only thing that is supposed to matter to the FDA are how safe the drugs are. Plan B has no apparent health consequences. So why has the FDA stalled in approving the drug, even after the agency's medical experts agreed on allowing broader sales?
If you've followed the debate at all, positions have subtly shifted in the last few months, and without much explanation, either.
In mid-August (August 18), Barr Pharmaceuticals, the maker of Plan B, submitted its third application to the FDA to allow over-the-counter sales of the medication, but only for women over 18. The first time around, three years ago, the company wanted the drug available to all women regardless of age. In its second try, the company set a minimum age of 16. Barr Labs declined to comment about why they were changing the age requirements, and there have been no studies to indicate that the medication is less effective or less safe for teenagers.
President Bush said a few weeks ago (August 21) that he supported over-the-counter sales of Plan B to everyone over 18 years old. This was the first time Bush had weighed in publicly in the debate, though last year several top FDA officials resigned over concerns that politics and science were entangling at the agency.
Is politics to blame? This time around, with the newfound blessing of the Bush Administration, it looks likely that Plan B will get approved for women over 18. Teenagers could still get it by prescription, and in six states it would be available to anyone under local laws.