Attorney and former FDA director of medical device compliance Larry R. Pilot has petitioned the agency to begin the administrative process to switch all oral contraceptives to over-the-counter status, arguing that their safety and effectiveness is well understood after 50 years of prescription status.
Pilot’s petition acknowledges that oral contraceptive drugs were initially approved by the FDA for prescription use in the 1960s and their increasing popularity led to the identification of serious side effects relating to strokes caused by thromboembolic events. But, it says, FDA solved this problem by requiring a package insert in the 1970s.
FDA, Pilot says, “recognized that the use of oral contraceptives were mostly initiated by women as a desirable commodity rather than a treatment for a disease. Access to the patient package insert enabled women to make an informed choice. This user awareness approach coupled with product refinements over time have established that these oral contraceptives, when used as instructed in accordance with approved labeling, are safe and effective for informed purchase and use by women.
“Consequently, like many treatment drugs which have been ‘switched’ from prescription to OTC purchase, women deserve the opportunity to decide for themselves whether to purchase acceptable OTC oral contraceptives from licensed pharmacies and practitioners,” the petition says.
It refers to other countries’ regulatory schemes for contraceptives to support the OTC switch. “Women in other countries are able to make an informed purchase without the costly and possibly onerous intermediary of a physician and/or third party payers,” Pilot says.
He also indirectly references the agency’s recent action for the emergency contraceptive Plan B and generic equivalents — “A precedent for this initiative occurred last year when the FDA allowed over the counter purchase for a different type of ‘contraceptive’ product.”
FDA’s approval of the OTC switch, Pilot continues, “will simply empower women to select their preference with advice if desired by pharmacists and other health care advisers. Because of this OTC choice opportunity, the costs and ‘paper work’ associated with office visit/pharmacist dispensing and third-party payment processing can be eliminated. Application of this ‘switch’ process also may help to reduce or eliminate part of the confusion associated with implementation of the Affordable Care Act as well as eliminate or reduce government and insurance costs.”
