Berliner Tageblatt - US panel recommends nonprescription use of contraception pill

The independent panel voted unanimously that the benefits of allowing the medicine, Opill, to be sold over the counter, outweighed the risks and would reduce hurdles associated with visiting a doctor that impact lower income groups disproportionately.

"I believe that the efficacy and safety of this birth control form was established over half a century ago," said panelist Jolie Haun of the James A. Haley Veterans' Hospital.

"We now have been presented with ample data demonstrating the effective safe use and benefits for people who want to have access to reproductive autonomy."

The committee's votes are usually accepted by the Food and Drug Administration, which means the pill, which is made by HRA Pharma, might be available without prescription in the coming weeks.

While likely, approval is not assured. FDA scientists highlighted safety concerns, such as the potential impact on people with a history or current diagnosis of breast cancer, or whether they would understand the pill needs to be taken the same time every day to prevent pregnancy.

"There is also concern that some consumers may not consistently use the product correctly on a chronic basis and be at risk for pregnancy, but not recognize that they are pregnant because of the irregular bleeding that would be ascribed to the known side effect," the FDA wrote in a document.

The push for a non-prescription pill has taken on new urgency in light of a Supreme Court decision overturning the constitutional right to abortion, leading to numerous bans and severe restrictions in conservative states.

It has received support from health groups such as the American Medical Association and American College of Obstetricians and Gynecologists.

If the pill is approved, the US would join more than 100 other countries where the pill is available without a prescription, including the UK which requires a consultation with a pharmacist.

Opill is known as a "mini pill" because it contains progestin only.

Another company, Cadence, is in talks with the FDA about making its combination pill, which contains both estrogen and progestin, available over the counter.

K.Thomson--BTB