Aug. 29, 2005 – In a move heavily criticized by womenâ€™s rights groups, the Food and Drug Administration (FDA) announced it was once again postponing a decision on the sale of over-the-counter emergency contraception. The recent decision comes after months of controversy over the agencyâ€™s handling of the application.
- FDA Delays Approval of Morning-After Pill, Considers Restrictions (Apr 10, 2004)
- Womenâ€™s groups: FDA caved on emergency contraceptive (May 10, 2004)
- Decision Expected Soon on â€˜Morning After Pillâ€™ Availability (Jan 25, 2005)
The delay is the second time this year that the FDA has put off a ruling on Plan B, an emergency contraceptive made by Barr Pharmaceuticals Inc. In announcing the decision to postpone a ruling on the drug, FDA Commissioner Lester Crawford said the FDA needed time to design a process for making Plan B available over the counter for women sixteen years of age and older, while continuing restricted access for younger women.
"What we are saying today is that the Agency is unable at this time to reach a decision on the approvability of the application because of these unresolved regulatory and policy issues that relate to the application we were asked to evaluate," Crawford said.
While he acknowledged that the FDA has determined Plan B is safe without a doctorâ€™s prescription for women 16 and older, Crawford said the agency is opening a 60-day public comment period about how to implement and enforce a two-tiered system of sale.
Ironically, it was the FDA itself that suggested Barr Pharmaceuticals submit an application allowing for age-specific access to the contraceptive. The agency had rejected a bid by the company to sell Plan B over-the-counter without age restrictions in May 2004, in spite of overwhelming endorsement of the drugâ€™s safety for any age by scientific panels convened by the FDA.
At the time, reproductive rights groups had cried foul, accusing the FDA of caving to political pressure from conservative politicians and organizations that oppose use of emergency contraceptives for moral reasons. Some fear it will encourage unprotected intercourse â€“ though studies have not borne this out â€“ while others say using the drug is the same as an abortion because in some cases it thwarts pregnancy by preventing a fertilized egg from attaching to the uterine wall.
Reproductive rights groups have fought their own battle to influence the FDA, initiating letter-writing campaigns asking the agency to follow the recommendations of its scientific advisors. Since the Plan B works best the sooner it is taken following unprotected intercourse, proponents of the drug say it is necessary to ease access as much as possible. They also note that requiring a prescription can put emergency contraception out of reach for women who have trouble finding a doctor to prescribe it in time.
When taken within 72 hours of intercourse, Plan B will prevent pregnancy 89 percent of the time, and rights groups say making the drug more widely available has the potential to dramatically decrease the number of unwanted pregnancies and abortions in the US.