Morning After Pill Over the Counter?
Aug. 1, 2006 -- Plan B, the so-called morning after pill, is once again at issue before the FDA.
Acting FDA Commissioner Andrew von Eschenbach, MD, yesterday called on the drug's maker to revise its application for over-the-counter status for the drug.
von Eschenbach suggested the company seek to make it available without prescription only to women 18 and older.
The emergency contraception for women is currently available only by prescription. The FDA proposal would not change Plan B's availability to women of all ages by prescription.
Duramed, a subsidiary of Barr Pharmaceuticals, is the maker of Plan B.
Nearly a year ago, the FDA delayed a decision on Plan B's over-the-counter application, citing "novel regulatory issues" about making the drug available to women under 17.
At the time, the FDA commissioner was Lester Crawford, DVM, PhD, who has since resigned. Senate hearings to confirm von Eschenbach as his successor are scheduled for today.
Yesterday, the FDA announced it is working with Duramed to resolve the issue.
"We believe that the appropriate age for OTC [over-the-counter] access is 18," wrote von Eschenbach in a letter to Duramed dated July 31, 2006.
The letter instructs Duramed to revise its Plan B over-the-counter application with that age restriction in mind.
The FDA and Duramed will meet "immediately," possibly wrapping up the process "in a matter of weeks," says an FDA news release.
About Plan B
Plan B contains a higher dose of levonorgestrel, an ingredient also found in prescription birth control pills.
The morning after pill is taken by mouth after unprotected sex. It can stop the release of an egg from the ovary, prevent the union of sperm and egg, or block a fertilized egg from attaching to the womb.
If a fertilized egg implants before a woman takes Plan B, the drug will not work, according to background information on the FDA's web site.