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FDA could widen path for OTC birth control, statins

Proposal would allow drugmakers to sell some products over the counter with an extra step to help mitigate safety concerns

A bottle of naloxone  with a needle. Naloxone nasal sprays, which are used to counter opioid overdoses, appear headed for over-the-counter use after an FDA advisory committee's recommendation.
A bottle of naloxone with a needle. Naloxone nasal sprays, which are used to counter opioid overdoses, appear headed for over-the-counter use after an FDA advisory committee's recommendation. (Getty Images)

A Biden administration proposal to broaden access to over-the-counter medications is drawing interest from manufacturers of products as varied as birth control, erectile dysfunction and cholesterol medication. 

But while some companies are already altering plans to fit the proposal’s requirements, the idea is also raising concerns among consumer advocates over cost and safety issues.

The proposed rule would allow drugmakers to sell certain products over the counter with an extra step, or an “additional condition for nonprescription use,” to help mitigate safety concerns. 

That could include a brief phone, online or in-store survey designed to weed out those at higher risk for side effects or who are taking other medications that could trigger harmful reactions. 

The Food and Drug Administration is aiming to finalize the rule by October, though that timeline is subject to change. 

The idea has been kicked around by regulators and companies for years and is likely to vary by product. The proposal is an invitation to drugmakers to submit their own ideas beyond a general self-selection questionnaire.

Some proposals could use tech or electronic health records to identify an eligible condition — though that would certainly raise privacy concerns — or require users to watch educational videos beforehand.

“I don’t know that anyone really knows what it will look like, because I think it’s going to be product specific,” said Marcia Howard, vice president of regulatory and scientific affairs at the Consumer Healthcare Products Association. 

Major drug manufacturers like AstraZeneca, Bayer and Sanofi as well as erectile dysfunction drugmaker Petros Pharmaceuticals have weighed in on the proposal, urging the FDA to loosen restrictions around the application process and address legal concerns that could prevent companies from pursuing the pathway. 

But safety advocates have weighed in as well, raising concerns about whether the proposed guardrails are sufficient for consumers to understand the risks.

“As soon as people know that something doesn’t require a prescription, they treat it differently,” said Diana Zuckerman, president of the National Center for Health Research. 

Birth control

At least one manufacturer is already adjusting its strategy. Cadence OTC is planning to use the proposed pathway — once finalized — for its combination estrogen and progestin birth control pill Zena, following conversations with the FDA, company co-founder and co-CEO Samantha Miller said. 

The company initially resisted the idea of requiring consumers to take an additional step before purchasing the pill, but ultimately began testing an online questionnaire designed to exclude those at higher risk of side effects.

“We and our experts believe we didn’t need it, and that we could have a well-performing, well-communicating label without it. And we did label development and testing for several years, and we did end up with a strong label that tested very well,” she said. “The FDA was not satisfied with it, and I think part of the reason they weren’t satisfied was that they had in their mind that this fit with this new approach.” 

The FDA did not respond to a request for comment. 

The combination pill has small but higher risks of serious side effects than progestin-only pills, including blood clots and stroke. 

At least one progestin-only pill is already making its way through the traditional OTC pathway. Opill maker HRA Pharma was scheduled to appear before FDA advisers in November, but the meeting was postponed to review new data.

The vast majority of consumers who use birth control pills take the combination pill, which means Zena would likely appeal to a broad number of consumers even if Opill gets the green light. 

Cholesterol

AstraZeneca is exploring potential over-the-counter use of its cholesterol drug, Crestor. The company has been testing how a web app could help consumers determine whether they’re eligible for the drug by inputting data like their cholesterol and blood pressure levels, prior health incidents and current medications.

The company did not respond to requests for comment.

Previous attempts to move other statin drugs over the counter have stalled. Pfizer abandoned its attempt to make Lipitor a nonprescription drug in 2015, citing studies that showed patients did not use the medication correctly. 

Emergency medications

The proposal could also potentially broaden access for easy-to-use emergency drugs that counteract common conditions.

Naloxone nasal sprays, which are used to counter opioid overdoses, appear to be headed straight to over-the-counter use after an FDA advisory committee unanimously recommended the move for Emergent BioSolutions’ Narcan earlier this month. The FDA has also scheduled a hearing for Harm Reduction Therapeutics’ 3mg nasal spray in March. 

But the FDA has also indicated that naloxone auto-injectors could be safe enough for OTC use, and the presence of a needle — no matter how well controlled — is a good scenario for additional safety instructions. With the exception of some older insulin products, there don’t appear to be any injectable drugs available OTC. 

“Once there’s a needle involved, that involves a whole separate slew of risks,” said Kalie Richardson, an associate at Hyman, Phelps and McNamara who focuses on drug regulation.

FDA advisers debated the label for Narcan’s nasal spray in-depth, signaling that a similar, more intense debate would likely occur for an auto-injector. 

The need for broader access is urgent. Corey Davis, director of the Harm Reduction Legal Project at the Network for Public Health Law, has been urging FDA to make the active ingredient, naloxone hydrochloride, over-the-counter broadly instead of approving individual products.

“All of this discussion about the labeling and all of this nitpicking is actually unnecessary and missing the point,” he said. 

Given the pending influx of OTC nasal sprays, it’s unclear whether any auto-injector manufacturers will take the trouble to bring one through the OTC pathway, especially since there don’t appear to be any existing products with doses as low as the FDA’s preferred 2mg threshold. 

The same concerns would likely apply to epinephrine auto-injectors for allergy reactions, even though some of the devices come equipped with automatic recordings that walk users through the simple, two-step injection process.

FDA advisers previously debated adding a QR code to the Narcan box that would lead to a training video, and stores could incorporate educational videos into their kiosks or cash registers. 

While there are clear upsides to expanding access to emergency medications like naloxone and epinephrine, additional training would also be a good idea, said Asthma and Allergy Foundation of America president Kenneth Mendez. 

And no one should lose sight of the need for regular care and treatment, particularly in cases like asthma, where patients can frequently rely too heavily on rescue inhalers like albuterol when their condition is not well controlled. 

“We want to make sure there’s no unintended consequence where patients won’t see their doctors,” Mendez said.

Access and safety debate 

While OTC drugs are easier to obtain than prescription ones, they also lack insurance coverage, which could throw up another access hurdle for medications that are typically covered with little to no copay, like birth control.

A number of states have laws requiring insurance coverage of birth control regardless of whether it’s prescribed, but those laws don’t apply to most large employer plans that operate under federal law.

“It would be one piece of the puzzle in making contraceptives more accessible,” said Michelle Long, senior analyst at the Kaiser Family Foundation Women’s Health Policy program. “But I feel like some of that excitement should be tempered a little bit.”

Cadence believes the retail price for a one-month supply of Zena would be under $20, but the final price has not yet been determined. Co-founder and chief medical officer Nap Hosang also noted how an OTC pill could help those who lack insurance, who forgot their medication while on vacation or who can’t tell their parents they’re using birth control. (Individuals can remain on their parents’ insurance until the age of 26.)

“There are certain cultural subgroups in the country where that’s really important,” he said.

Pharmacy groups are pushing FDA to include them in the process, raising safety concerns and noting how state laws vary. 

“Pharmacists are primary guardians of the public health and must retain their ability to supervise and consult with prescribers and patients within their scope of practice,” the National Community Pharmacists Association wrote to the FDA.

Zuckerman listed a number of ways that people commonly misuse OTC medications, including by taking higher doses of a generic because they think it’s weaker, or taking more pills to try to get better faster. She recounted how she often overlooks the drug-related questions at the CVS pharmacy checkout, mistaking it for the credit card screen.

She also pointed to TV commercials that try to sell consumers on the idea of a better life, raising concerns about the larger number of people who could directly access a drug being advertised.

“You’re not even getting particularly much information,” she said of the ads. “You’re getting a feeling.”