WASHINGTON, July 23, 2004 (LifeSiteNews.com) – This May, the Food and Drug Administration rejected nonprescription sales of emergency contraception, in the midst of controversy. Now the manufacturer of the abortifacient drug is again pressuring the US government to allow its sale without a prescription. The FDA decision left a loophole when they said they might reconsider if the company, Barr Pharmaceuticals, could show some way of guaranteeing that the drug will only be sold without prescription to girls and women over 16.
In their letter to Barr, the FDA said that there would have to be some means of selling the product as both a prescription-only and non-prescription drug and to educate the public as to the difference. The mixed marketing approach is called a ‘novelty’ in the letter and the FDA has never before approved such a scheme. A spokesman for Barr said that the legal counsel has found a way to comply with the FDA stipulations. “We are pleased to be responding to the FDA with a submission that we believe will lead to approval of use of Plan B emergency contraceptive as an over-the-counter product for women 16 and older will maintain the availability of Plan B as a prescription-only product for women age 15 years and younger,” said Dr. Carole Ben-Maimon, President and COO of Barr Research. ph