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Barr Re-applies for OTC Emergency Contraceptive in Women and Girls Over Sixteen

In May, the Food and Drug Administration (FDA) rejected an application by Barr Pharmaceuticals to market their Plan B^® emergency contraceptive product over-the-counter (OTC). 

Staff Report

August 9, 2004

In May, the Food and Drug Administration (FDA) rejected an application by Barr Pharmaceuticals to market their Plan B^® emergency contraceptive product over-the-counter (OTC).  The rejection came after a recommendation in December 2003 by the FDA’s scientific advisory committee that the high-dose contraceptive should be available without a prescription for girls fourteen or older. 

The decision followed months of intense lobbying for and against the approval by politicians, medical groups, religious organizations and others.  In April, the FDA delayed their decision and was attacked for playing politics with science by the editors of the New England Journal of Medicine.  The rejection of the scientific advisory board’s recommendation to approve the contraceptive option was a great surprise to many in the scientific community.  In a letter to the company, the FDA determined that the application did not include enough data on how girls younger than 16 would use the product.

The FDA did state that Barr could reapply for OTC approval of Plan B^®

if they either provided more data on younger patients or provided details on how the product would be labeled and marketed if it were to be OTC for girls over 16 and prescription for younger girls. 

The FDA writes in their May 6^th decision, “Before this application can be approved, you would have to provide data demonstrating that Plan B can be used safely by women under 16 years of age without the professional supervision of a practitioner licensed by law to administer the drug.  Alternatively, you could supply additional information in support of the revised indication to allow for marketing of Plan B as a prescription-only product for women under the age of 16 years and a nonprescription product for women 16 years and older, including draft product labeling.”

In late July, Barr provided a marketing plan that would allow women 16 and older to purchase Plan B without a prescription while younger girls will still have to get a prescription.  The FDA has six months to respond to the application.  Supporters have argued that making Plan B over-the-counter will allow poor women and girls to use the product when it is most effective, within the first 24 hours after unprotected intercourse.  Critics of the OTC plan counter that it will increase the rate of unprotected sex and encourage risky sexual behavior among young women. 

Given the scientific advisory committee’s overwhelming support for approval of Plan B for OTC sale and the FDA’s letter regarding the potential approvability of a marketing plan to women 16 and older, its decision on the revised application is an important test of the agency’s ability to make medical decisions free of political influence. 

References

Barr Submits Response to FDA in Support of Over-the-Counter Status for Plan B(R) Emergency Contraceptive (Press Release) Barr Pharmaceuticals (7/22/04)

FDA's Decision Regarding Plan B: Questions and Answers.  Food and Drug Administration. Center for Drug Evaluation and Research. (5/7/04)

Plan B “Not Approvable Letter” Food and Drug Administration. (5/6/04)