FDA delays decision on ‘morning-after’ pill
- Sep 15, 2005
The U.S. Food and Drug Administration has delayed a decision on whether to permit over-the-counter (OTC) sale of the Plan B “morning-after” pill.
Though described as an “emergency contraceptive,” Plan B can act as an abortifacient, blocking implantation of a tiny embryo in the uterine wall. As a result, many pro-life advocates oppose its sale, especially without a prescription.
Plan B, which also works by restricting ovulation in a woman, now may be purchased by prescription only.
The FDA informed Barr Pharmaceuticals Inc. Aug. 26 it had decided to postpone action on the firm’s application to sell Plan B without a prescription. The FDA’s Center for Drug Evaluation and Research had decided current scientific evidence supports the distribution of Plan B over the counter for women 17 years of age and older, the agency’s commissioner, Lester Crawford, announced. The agency, however, will seek public comment for 60 days on OTC sale of the drug for this age group and prescription sale for females 16 and under, Crawford said.
Only six weeks before Crawford’s announcement, however, it appeared the FDA had set a Sept. 1 deadline for deciding whether it would permit OTC sale of Plan B. Michael Leavitt, secretary of the Department of Health and Human Services, said in a letter to U.S. senators the agency should have a decision by that date. After Leavitt’s disclosure, Democratic Sens. Hillary Clinton of New York and Patty Murray of Washington announced they would release their hold on Crawford’s nomination as FDA commissioner. The Senate subsequently confirmed Crawford.
After Crawford’s announcement, Clinton and Murray said, “It is a breach of faith to have this administration give their word that a decision would be made and have that promise violated.”
Crawford, however, said there were “unresolved regulatory and policy issues” that need to be addressed, especially regarding concurrent OTC and prescription use for the same purpose and in the same package.
Citizens may comment on the Plan B application by clicking on “Comment on Proposed Regulations” at www.fda.gov and following the directions. The docket number is 2005N-0345. The deadline for comments is Nov. 1.
The “morning-after” pill is essentially a heavier dose of birth control pills. Under the regimen, a woman takes two pills within 72 hours of sexual intercourse and another dose 12 hours later. In addition to Plan B, the FDA has approved prescription use of another “morning-after” pill, Preven.