Bishops’ Conference Tells FDA That Over-The-Counter Sale of “Morning-After” Pill Would Be Harmful to Minors

From the USCCB Office of Media Relations:

WASHINGTON (October 27, 2005)— In a letter to the Food and Drug Administration, an official of the United States Conference of Catholic Bishops (USCCB) opposed permitting over-the-counter sale of the Plan B “emergency contraception” pill to minors.

Mark E. 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 the Plan B “morning-after” or “emergency contraception” pill available over the counter to persons over the age of 16.

“We believe, as we stated in previously filed comments, that permitting over-the-counter sale of Plan B would be detrimental to minors (and adults) notwithstanding any effort to limit marketing to adults,” Mr. Chopko wrote in an October 27 letter to the FDA.

Mr. Chopko said the position of the USCCB is based on the following considerations:

“First, if Plan B became available over-the-counter, even if such availability were ostensibly limited to adults, it would as a practical matter 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.

“Second, without parental involvement, and professional oversight, minors with access to Plan B may rely upon and use it to the detriment of their health. It can be expected, for example, that many girls (indeed many adult women) will take Plan B multiple times rather than as recommended…In our previous comments, we pointed out the significant health risks that would be occasioned by the absence of clinical oversight and monitoring. A child will not always appreciate these risks or necessarily understand where to turn when complications arise.

“Third, over-the-counter availability will undermine efforts to encourage parents’ participation in decisions affecting the health of their dependent minor children at a time when the Administration…has been promoting and defending such efforts.” Mr. Chopko noted that the United States has recently filed an amicus curiae brief in which it urges the Supreme Court to uphold a New Hampshire law requiring parental notice for minors seeking an abortion.

“Fourth, over-the-counter availability has implications for whether 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. Over-the-counter use does nothing to educate potential users of Plan B in this regard – indeed, Plan B has been widely promoted as not causing abortion – and 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.

“Fifth, over-the-counter availability will likely compound the pressure already being placed upon health care providers and professionals to violate their conscience. Even now there are published reports in some jurisdictions of efforts to require pharmacies and pharmacists to carry Plan B and make it available notwithstanding their conscientious objection to the drug, and that effort has already resulted in litigation.”

“We ask the FDA to reject the current application, and any subsequent application, to make Plan B available over the counter either generally or to any subpopulation,” Mr. Chopko wrote.

Previous USCCB comments on over-the-counter availability of Plan B can be found on the Web at www.usccb.org/ogc/ruleind.shtml.