Editor’s note: Welcome to Editors' (re)View, our editors’ takes on things going on in the pharma world that deserve some extra consideration.
Perrigo launches OTC birth control
Following the Supreme Court's overturning of Roe v. Wade in 2022, the U.S. saw a stark divide in reproductive health care access. A dozen states imposed outright bans on abortion, diverging from global trends toward liberalizing such laws.
Responses across states varied significantly: some strengthened abortion access through legislative protections, while others introduced stringent restrictions, making abortion illegal in 14 states within months of the Dobbs decision.
This regulatory mosaic has intensified disparities in reproductive care access, notably affecting marginalized groups. Challenges to the FDA's approval of mifepristone, a key drug in medical abortions, highlight the broader impacts of these legal shifts on health care access and underscore the contentious nature of reproductive rights in the post-Roe landscape.
But in a hopeful chapter in the unfolding reproductive rights story, earlier this week, Perrigo announced it has begun the distribution of Opill, marking the first time a daily birth control pill is available over-the-counter in the U.S.
The move follows the FDA's historic decision last year to allow the sale of Opill without a prescription to individuals of all ages, a step poised to revolutionize access to contraceptives. Retailers nationwide will stock Opill in both one-month and three-month packages, priced at $19.99 and $49.99, respectively.
The journey of Opill from a prescription product approved by the FDA in 1973 to an OTC option reflects a significant shift in contraceptive accessibility. Perrigo, after acquiring HRA Pharma in 2022 and inheriting the mission to transition Opill to OTC status, successfully navigated the FDA's approval process amidst delays and challenges, culminating in approval in July 2023.
And Perrigo is not alone in the quest to expand access to birth control through Rx-to-OTC switches. Cadence OTC is also in the race, working on bringing Lo/Ovral and Alesse, two estrogen-progesterone combo oral contraceptives, to the OTC market. — Andrea Corona
Eli Lilly speaks out against vanity use of weight loss drugs
In the process of covering Eli Lilly’s bad news about the delayed regulatory decision for its Alzheimer's drug, donanemab, something else caught my eye — the company’s new ad campaign for obesity care.
I'll start by saying, to Eli Lilly's credit, its message about obesity care has remained consistent: obesity is a disease and should be treated as such.
For the 42% of Americans struggling with obesity, incretin-based injectables are a lifeline — offering what’s arguably the first safe and effective pharmacologic weight-loss tool in history. But the demand for the two weight-loss injectables on the market (Novo's Wegovy and Lilly's ZepBound) has been so high that many patients can’t find them, instead turning to diabetes counterparts, Ozempic and Mounjaro, to fill the void. This off-label demand has contributed to ongoing shortages.
The situation has been made worse by unsolicited celebrity endorsements on social media and even at last year’s Oscars. Many of these celebrities do not medically qualify for obesity treatments — and now, Eli Lilly is calling them out.
“Some people have been using medicine never meant for them…for the smaller dress or tux, for a big night, for vanity,” begins Lilly’s new ad, released ahead of this Sunday’s Oscars ceremony.
It’s a bold move to tell celebrities you don’t want their money, but one could argue the message is tinged in irony since the drug’s price tag and lack of payer coverage puts it out of reach for those without excessive disposable income.
Despite the lobbying of both Lilly and Novo, coverage for weight loss meds remains poor. Lilly CEO David Ricks estimated that half the people in America with obesity, including those on Medicare, can’t get insurance coverage for the drugs.
It remains to be seen how drug companies will overcome this huge hurdle in access. As additional drugs gain approval, market competition will likely drive down prices but the drugs are still a long way from being affordable to all. But for now, it’s probably safe to say celebs won’t be getting a ZepBound pen in their Oscars swag bag. —Karen Langhauser
