Nov 9 2005
According to a Food and Drug Administration official, regulators may take months to review public comments on Barr Pharmaceuticals Inc.'s application to sell the Plan B "morning-after" contraceptive without a prescription.
Apparently the FDA received thousands of comments after it indefinitely postponed a ruling on Plan B in August and asked for public input.
Dr. Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs, says it could take months to go through the comments.
As the deadline for submitting comments ended last week the agency was expecting as many as 10,000 submissions.
Gottlieb has disputed charges that the FDA has allowed politics to interfere with science when they delayed a ruling on Plan B following heavy lobbying by conservative groups against the over-the-counter sale of the drug.
Many women's and medical groups supported an FDA advisory panel which recommended allowing over-the-counter sales in December 2003.
Gottlieb says in his view former FDA Commissioner Lester Crawford "made his own independent decision" to seek public comments on issues such as how to keep the prescription requirement for girls younger than 17, while easing access for older women.
Plan B is a set of pills that may prevent pregnancy if taken within 72 hours of sexual intercourse.