A Difficult Proposition: Oral Contraceptives' Switch from Prescription to Over-the-counter Status

Abstract

The choice between maintaining oral contraceptives at their current prescription drug status or switching the drugs to over-the-counter status, like so many other decisions in Food and Drug Law, has as much to do with science, as it does with politics and economics. If the second component of section 503(b)(1)(B) of the FD&C Act gave more formulaic guidance for determining which drugs were exempt from its reach, then determination of drugs’ prescription/nonprescription status would be simpler. Yet if this were indeed the case, then the amended statute would not leave room to analyze the total social cost versus the total social benefit that a drug’s availability over-the-counter would inspire. Protection of the public health, Congress’s ultimate purpose for the FD&C Act and its 1951 amendments, would be difficult to achieve. Although the pill’s lower toxicity level translates to less risk of harmful side effects than was the case when it was first introduced in the 1960s, the pill is still not without its risks, especially for women with high risk group characteristics. Maintaining the pill’s prescription status ensures a pre-use screening by a clinician and decreases the probability of oral contraceptive use by high risk consumers. This is a compelling reason to maintain the status quo, but is restriction of a contraceptive, especially with the establishment of contraception as a fundamental privacy right, the least costly solution to maintaining the public health? If we have any faith in the increasing intelligence of consumers and in information and education efforts such as package labeling and patient package inserts, perhaps increase in high risk women actually using oral contraceptives will not be as great as opponents of a switch to over-the-counter status predict.