When the FDA approved the first-ever over-the-counter daily birth control pill this month, Frederique Welgryn breathed a giant sigh of relief for all the reasons you might expect.
As a leader at the Paris-based HRA Pharma and now global vice president of women’s health at its parent company Perrigo, Welgryn has worked with U.S. regulators for close to a decade to move the progestin-only Opill onto drugstore shelves.
The victory, she said, was well worth the wait.
“When we saw that we had a unanimous, positive vote from the 17 members of the (FDA) advisory committee panel, (it) was probably one of the greatest moments of my professional career,” Welgryn said. “It's been difficult. It's been long. But it's so rewarding to see all the reactions.”
Perrigo’s application landed on the FDA’s desk just weeks after the U.S. Supreme Court ruled 6-3 to eliminate federal abortion protections last year, sparking fears that the court could also soon attempt to restrict contraceptive access. And while the drugmaker’s application was unrelated, the weight of the moment led to increased scrutiny of the FDA’s review.
Now, the drug’s approval has been heralded as a major milestone toward expanding access to contraception and reducing the risk of unintended pregnancies in the U.S. Still, advocates remain concerned that pricing and coverage constraints could continue to limit access. And some are pushing the federal government to mandate that health plans cover OTC contraception.
Here, Welgryn discusses how Perrigo is approaching conversations about access and affordability, the target audience for Opill and what the approval means for women across the U.S.
This interview has been edited for brevity and style.
PHARMAVOICE: Perrigo’s application for OTC birth control came just weeks after the Supreme Court overturned Roe v. Wade. Walk me through the decision to apply for OTC status at that moment.
FREDERIQUE WELGRYN: It’s completely coincidental to be honest. Opill was first approved by the FDA in 1973. And HRA acquired the drug in 2014 with the intent from the very beginning to conduct an Rx to OTC switch, because at the time, we knew that there was a massive need for more access to effective contraception in the United States. The whole point of the process was to prove that women can select birth control pills themselves and can use them without the supervision of a health care professional.
For more than nine years, we've been working to conduct the research, actual use trials and other clinical research, which are necessary to apply to get the FDA to bring Opill OTC. It’s been a long journey and when we came to the end, yes Roe was overturned. We had all the research completed and we thought ‘So many freedoms are being taken away from women in this country, it’s a necessary step forward for women.’ It’s not that contraception is ever going to replace abortion, but it’s probably the first good news for women's reproductive rights in this country for at least a couple of years. We didn't hesitate for one second because it was just something that was even more important at the time.
What was it like to be a scientist suddenly at the center of a major political debate?
When you start to touch anything that relates to women's reproductive rights in the United States, you know that it is always going to be under the spotlight. Fortunately, this is another win — not only the approval but the fact that the processes has been based on science. It's been based on a thorough research program. It's been supported by independent experts from the advisory committee panel. In addition, we've had support from all major medical organizations, including the American College of OBGYNs, the Society for Adolescent Health and Medicines, etc. So, fortunately this process has never been political.
Who do you anticipate the target patient for this OTC birth control will be, as opposed to prescription formulations?
Today, 40 million women of reproductive age are sexually active and don't want to get pregnant. 15.3 million women in the U.S. are using a less effective method of contraception or no method at all — so they're using condoms, spermicide or no method. And 10 million are using the pill, yes. But 30% that use it sometimes don't have time to get an appointment; they don't have time to miss work to go see a doctor; they don't see the necessity of doing these things. So those women are really the ones that will benefit from having Opill available OTC because they can just walk to their store and get the product and that's what they want. Some women will continue to take the pill exactly as before; they will continue to see a doctor; they will continue to get their prescription and that's perfectly fine. Others who are suffering from the barrier of getting a prescription will be happy to find Opill OTC. And this is for those women that Opill is here.
"It’s probably the first good news for women's reproductive rights in this country for at least a couple of years."
Global VP, women's health, Perrigo
What pricing and access conversations you are having at this moment?
Since the very beginning, we’ve been saying that Opill would be accessible in all stores nationwide and online. We also said that we would work on pricing so that Opill is affordable for most women. There's still going to be an out-of-pocket cost, of course, but we're looking at something that is affordable. We will probably talk about the manufacturer's suggested retail price in a couple of months. We're in discussion to get Opill listed at launch with insurers. We're also working on a consumer assistance program as well to make sure that people who struggle to make ends meet can access Opill. And we are also on a journey to understand what we can do to take insurance coverage. In the United States, OTCs are not covered by insurance. So that's going to need more work to get that done. But because Opill was approved, there are voices saying, ‘We need to get that covered. We need to get birth control covered.’ So I feel there is momentum and we want to be here to support that momentum.
Are you working with insurance companies to facilitate that?
We have already started having conversations and we're trying to see what can possibly be done. Again, this would need a change of regulation. But there are many people in the country who are keen on making this happen sooner rather than later and we want to support those efforts.
You said you are expecting to go to market by the beginning of 2024. What informed that timeline?
Essentially, we need to manufacture the product. We were granted approval only on the 14th of July There are a couple of tweaks to the back (of the packaging) because we needed to get FDA’s comments on all those elements of the brand. Now the process is starting, and I believe that it's reasonable that we'll have Opill in stores and online in 2024.
Are you worried about how the future political environment in the U.S. could impact access to this medication?
One can’t predict the future, but so far, what we've seen is that there has been bipartisan support for OTC birth control. Seventy-seven percent of women support birth control OTC. I believe this is a fundamental right and contraception should not be at the center of any political debate. This has been the case until now, and I hope that will continue to be the case.