FDA could widen path for OTC birth control, statins
Lauren Clason, Roll Call, March 2, 2023
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.
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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.
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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.
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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.”
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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.”
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