In general, the panel is much more positive on the data and the benefits here than the FDA is. This is actually pretty common. Advisory committees tend to be more progressive than the FDA itself.

Annnd it's lunch break time, folks! Back in action at 12:30pm ET.

The panel is back from lunch. Members have made it clear they don't want FDA to require additional studies, but because the FDA asked for suggestions on design of potential new studies, the panel is being redirected back to that question.

Several suggestions were made, but again with a caveat that the panel strongly recommends against requiring additional studies.

The panel is moving on to its final question: Whether people who should NOT take Opill will correctly 'deselect,' meaning not use it.

The number of people who absolutely should not take Opill is small. The only major contraindication is breast cancer, and the panel seems confident that people with breast cancer will correctly avoid Opill and all other hormonal contraceptives.

Another concern is that people with undiagnosed vaginal bleeding could take Opill without talking to a doctor, delaying a potential cancer diagnosis. But OBGYNs on the panel say this risk is low.

Bleeding between periods is pretty common for teens, and not dangerous—they're extremely unlikely to have cancer, and in fact, the first-line treatment of this bleeding is hormonal birth control.

The FDA also raised a concern that people already using a hormonal contraceptive might use OTC Opill. Docs on the panel aren't worried about that, either. It's unlikely, and there are actually lots of situations in which two hormonal contraceptives are prescribed together.

The FDA is sounding a little defensive! They say they 'really realize' how important it is to improve access to birth control. But they are still not happy about the studies submitted here.

Ok, y'all, it's voting time. Voting members of the panel will take a few minutes to cast their votes. We'll get an announcement of the vote tally first, then panelists will have a chance to explain their votes.

BREAKING: An FDA advisory committee has voted UNANIMOUSLY to recommend that the FDA approve Opill, a progestin-only birth control pill, for over-the-counter use. If approved, Opill will be the first OTC oral contraceptive pill in the U.S.