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Use, ok Fda first contraceptive pill without prescription
Green light from the FDA to the first contraceptive pill sold without a prescription. The US Medicines Agency announced yesterday evening the approval of Opill, a progestogen-only (norgestrel)-based OTC contraceptive, to be taken every day at the same time. The OK from the US regulatory body will make the medicine available in pharmacies, convenience stores and grocery stores, as well as online. Timing and price will depend on the manufacturer, the Perrigo group based in Ireland, which has acquired the French Laboratoire Hra Pharma to which we owe the development of Opill.
“With this approval – explains Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research – for the first time a daily oral contraceptive without a prescription will be an option available to millions of people in the United States. When used as directed, the drug is expected to be safe and more effective than currently available non-prescription methods of contraception in preventing unwanted pregnancy.”
The US agency recalls that “almost half of the 6.1 million pregnancies that occur each year in the United States are not intentional”, and that unwanted pregnancies have been linked to risks such as “a reduced probability of receiving early prenatal care and an increased risk of preterm birth, with negative outcomes for the health of the newborn and the development of the child”. Therefore “the availability of Opill without a prescription can help reduce the number of unintended pregnancies and their potential negative impact.”
The contraceptive efficacy of norgestrel was established in 1973 with the approval of the prescription version. «Hra Pharma has therefore requested the switch of norgestrel from a prescription drug to an over-the-counter product», a type of drug for which the go-ahead «the FDA requires the company to demonstrate that the product can be used by consumers in a safe and effective, relying only on the package insert, without any assistance from a healthcare professional.
The studies, reports the regulatory body, have shown that consumers’ understanding of the information on the package is “high overall” and that “a high percentage of consumers understand the instructions for use”. The FDA is keen to clarify that Opill should not be used as an emergency contraceptive, and that in general oral contraceptives do not protect against the risk of sexually transmitted diseases. To avoid them, the use of condoms is recommended.