FDA dragging its heels yet again over 'morning after' pill Plan B

Women in the U.S., unlike their counterparts in the UK and other countries, will still be denied easy access to the 'morning after' contraceptive pill, Plan B, after a decision by the Food and Drug Administration to yet again delay ruling on over-the-counter sales.

The ruling has again evoked claims that the repeated delays are motivated by politics rather than science.

According to FDA Commissioner Lester Crawford, the drug creates "unique regulatory issues", in how to retain a prescription requirement for girls younger than 17, while giving access for older women.

The FDA will apparently accept public comments for 60 days, but Crawford will not predict when a decision will be made.

Drug company Barr Pharmaceuticals has requested the right to sell the product, Plan B, to females 16 and older without a prescription.

The FDA said its scientists supported safe, over-the-counter use by women 17 and older.

The preparation Plan B pills contain higher doses of progestin, which is one of the hormones used in birth-control pills; women are advised to take two tablets 12 hours apart.

Many groups, including reproductive rights groups, say easier access would help women get the pills in time following a rape or broken condom, leading to fewer abortions, while Conservative opponents claim that wider availability would lead to more promiscuity and sexually transmitted diseases.

Kirsten Moore, president of the Reproductive Health Technologies Project accuses the FDA of continually procrastinating and says there there is no way to ensure underage girls would not get the pills and "that this is the end of it".

But the group, Concerned Women for America (CWA), a conservative group that opposes over-the-counter sales, has welcomed the FDA decision.

Wendy Wright, CWA's senior policy director, says it is naive to assume any over-the-counter scheme for the morning-after pill would be effective, as a 17-year-old could buy it for a 13-year-old girl, or worse yet, a pedophile could purchase this drug for his victims.

Democrat Senators Patty Murray of Washington and Hillary Clinton of New York, have accused the Bush administration officials of breaking a promise to rule on Plan B by September 1.

Both Murray and Clinton agreed to drop objections to a vote on Crawford's nomination as FDA commissioner because of that pledge.

The senators said in a joint statement, that it was a breach of faith to have the administration give their word that a decision would be made, and have that promise violated.

They say the FDA's only criteria for approval should be safety and efficacy, not politics and ideology.

Barr's attempt to sell Plan B without a prescription has repeatedly been thwarted.

In December 2003 an FDA panel of outside advisers voted 23-4 to recommend reclassifying Plan B from a prescription to over-the-counter drug, but the FDA rejected that advice in May 2004.

When Barr later reapplied for approval of an over-the-counter version for females 16 and older, the FDA missed a January deadline to rule on the application.

The company says the delay was unjustified and is "disappointed" by the latest FDA ruling.

Barr says it means to continue to press for over-the-counter approval for Plan B, which will remain available only by prescription.

Apparently Plan B is different from the "abortion pill" RU-486, also known as Mifeprex or mifepristone, which can terminate an early pregnancy by blocking the hormone that keeps a fertilized egg implanted in the uterus.

Plan B works by blocking the release or fertilization of an egg.

Some research suggests Plan B also may keep a fertilized egg from attaching to the womb.