Federal regulators and Barr Laboratories, the makers of Plan B, otherwise known as the Morning-After-Pill, reached an agreement on Monday which could mean OTC (over-the-counter) sales of the drug will happen in a matter of weeks.

Barr Pharmaceuticals has to resubmit its OTC application for Plan B within two weeks. The FDA says it will respond swiftly, according to a report in The New York Times.

The OTC status will only be for women over 18 and only pharmacies and licensed clinics will be authorized to do so (sell it as an OTC drug). Younger girls will need to go to their doctors and get a prescription. This is what the FDA wants Barr Pharmaceuticals to include in its new submission.

According to a telephone conversation between Bruce Downey, Chairman of Barr Pharmaceuticals, and Andrew C. von Eschenbach, acting commissioner of the FDA, quoted in the New York Times, the FDA is intent on sorting out the present Plan B stalemate.

Three years ago an FDA advisory committee recommended that Plan B be available as an OTC drug for all women, regardless of age. The FDA nearly always does what the committee recommends. However, in this case the drug has remained a prescription only drug.

Scientists and doctors believe the FDA’s reluctance has been due to political pressure, rather than science. Andrew C. von Eschenbach would like to become the permanent boss of the FDA, for the moment his position is only temporary. In order to get the job he needs the approval of a Senate committee. This committee has two democrats who have put the vote on hold until he sorts out The Morning After Pill impasse. Consequently, the drug’s change of status has suddenly become a top priority for the FDA.

Critics can now argue either way, and in both cases the accusations would be of succumbing to political pressure. The decision to keep it as a prescription only drug for so long brought accusations of right wing pressure. Now, the current decision could bring criticism of the FDA succumbing to pressure from the liberals.

Plan B, or The Morning After Pill, reduces a woman’s chances of becoming pregnant by 89% if she takes the medicine within 72 hours of engaging in unprotected sex. The treatment consists of two pills. The drug is a contraceptive.

Written by: Christian Nordqvist
Editor: Medical News Today