Merck wants to sell the bladder drug Oxytrol over the counter. Naturally, it has asked FDA for permission to do so. And now, the agency is preparing for an advisory panel meeting to weigh that request. This all seems quite routine in the annals of drug approvals.
But it's not. As Merck ($MRK) exec Edwin Hemwall told Bloomberg, it's been 5 years since FDA last convened an advisory panel to discuss a drug's move to OTC status. And the panel meeting comes at a time when the agency is weighing a sea change in the prescription-versus-nonprescription drug calculus.
Earlier this year, FDA floated the idea of opening access to prescription meds such as cholesterol fighters and blood-pressure remedies. Whether by moving drugs to drugstore shelves, setting them up for behind-the-counter sales, or even creating some sort of electronic gatekeeping system for patients to qualify for certain meds, the agency figures that easier access might induce more people with chronic health problems to seek treatment.
Will Merck and Oxytrol become beneficiaries of that new attitude? In documents released ahead of Friday's meeting, FDA staff asked the advisory panel to consider whether Merck has shown that women can use the overactive-bladder patch safely. In Merck studies, some consumers chose to use the drug despite health conditions that made Oxytrol wrong for them; in fact, some men chose to use it, despite the fact that it was labeled specifically for women. Whether the confusion was common enough or serious enough to cause concern is up to the committee to decide.
The FDA staff also reminded the panel of the agency's policy on nonprescription availability: "In accordance with FDA regulations, if a drug can be OTC, it should be OTC," the documents said (as quoted by Bloomberg). Oxytrol would be the first OTC treatment for that condition.
- read the Bloomberg story