The Food and Drug Administration (FDA) in the U.S., meets early next week with the manufacturer of the controversial contraceptive Plan B, in an attempt to resolve the issue of the morning-after contraceptive.
The FDA says it is taking a new look at Barr’s Pharmaceuticals application to sell Plan B without a prescription which has been with the FDA since 2003.
The agency wants the pills kept behind pharmacy counters; women would have to ask for them and those under 18 would still need a prescription.
Plan B is a set of two pills that can prevent pregnancy if taken within 72 hours of sexual intercourse and has provoked controversy, with both supporters and critics relentlessly lobbying the FDA.
It has also held up the confirmation of nominee Andrew von Eschenbach as FDA chief, as Democrat Senators Patty Murray and Hillary Rodham Clinton among others have expressed their intention of blocking a vote on von Eschenbach’s nomination unless the agency makes a final decision on whether to approve over-the-counter Plan B sales.
Just one day after the agency announced it would seek an agreement with the Plan B manufacturer abortion advocates on a Senate committee sharply questioned von Eschenbach on the morning after pill.
Democrats on the Senate Committee on Health, Education, Labor and Pensions (HELP) praised von Eschenbach’s resume but questioned what they called a “politicized” handling of the morning after pill.
Although von Eschenbach told the panel he is committed to “sound science”, many questioned the timing of the Plan B announcement this week and suggested there was a disregard of science for ideological concerns.
They also questioned the FDA’s decision to sell the morning after pill only to women over the age of 18 when the FDA previously told Barr Laboratories it would consider a revised application to sell the drug through pharmacies to women over 16.
HELP Committee Chair Mike Enzi said he plans to hold a vote on the nomination after the Senate’s August recess and says the question is not whether to confirm him, but whether to confirm him before Plan B is approved.
It is thought President Bush may consider using a recess appointment later this month to name him commissioner and when Hillary Clinton asked von Eschenbach if he would accept a recess appointment, von Eschenbach said he wanted the Senate’s confirmation of his appointment as commissioner of the FDA.
The FDA says the contraceptive Plan B could be approved for women 18 and older within weeks.
An FDA advisory panel of the agency’s independent scientific advisers overwhelmingly backed nonprescription sales for all ages in 2003 and the laws in eight states in the U.S., already allow women to buy Plan B from certain pharmacies without a prescription and with no age restrictions.
Revision date: June 11, 2011
Last revised: by Sebastian Scheller, MD, ScD