Nonprescription morning-after pill harmful, USCCB tells FDA

Abuja, Nigeria, Oct 27, 2005 / 22:00 pm

The U.S. bishops are urging the Food and Drug Administration to reject all applications to make Plan B, also known as the morning-after pill, available over the counter.

In an Oct. 27 letter to the FDA, Mark Chopko, USCCB general counsel, said Plan B “is one instance of a drug in which over-the-counter availability, either generally or to a subpopulation, would be injurious to many—children and adults, as well as health care providers and professionals.”

On August 26, the FDA invited public comment on the circumstances under which an active ingredient may be simultaneously marketed in both prescription and over-the-counter form. The notice of proposed rulemaking came in response to an earlier proposal to make Plan B available over the counter to persons over the age of 16.

Chopko included the USCCB’s five reasons for their opposition. First, if Plan B became available over-the-counter, it would make it easier for minors to obtain the drug without a physician’s or parent’s involvement.

“A minor could procure the drug indirectly through a non-parental adult, or might obtain it directly as a result of lax enforcement by the pharmacy, misrepresentation, or theft,” the bishops argue.

The bishops also fear that girls and women will use the pill multiple times, rather than as directed, to the detriment of their health. Third, over-the-counter availability will undermine efforts to encourage parents’ participation in decisions affecting the health of their dependent minor children.

Fourth, over-the-counter availability does nothing to educate women about the drug and its implications. As such, it may put into question whether a user’s consent will be truly informed.

“Girls (and many adult women, for that matter) may be unaware that in some circumstances Plan B can have an abortifacient effect by interfering with the survival of a newly conceived human being,” the bishops said. “Over-the-counter use … will only increase the likelihood of continued ignorance about the drug’s mechanisms, which in turn affects whether consent to its use is truly informed.

Finally, over-the-counter availability “will likely compound the pressure already being placed upon health care providers and professionals to violate their conscience.” The bishops noted that the question has already been raised about whether or not pharmacists could refuse to sell the drug according to their conscience.