FDA Considers Moving Migraine Medications to OTC Status

The Food & Drug Administration recently announced it will study a proposal to move certain medications for treatment of chronic diseases like migraine and diabetes to over the counter status.

This means those medications would no longer require a doctor's prescription or perhaps only require a prescription the first time the patient uses the medication or a consultation with a pharmacist. This change would be years in the works and each medication would have to separately apply to be moved to over the counter status. In anticpation of the FDA's planned two day public hearing on this issue, there are some significant pros and cons to such a decision that you should be aware of as an informed, engaged migraine patient.



Improved access.

There are thousands, if not millions, of patients with chronic diseases like ours who are unable to access readily available treatments because they don't have insurance and can't afford the cost of a doctor's appointment. For example, experts estimate as many as 7 million people have diabetes, but are as yet undiagnosed and not receiving treatment because they don't have access to a doctor.


Rather than having to see their doctors, take a prescription to the pharmacy and come back to pick it up, patients could buy what they need right off the shelf, the same way you buy something to treat a cold or constipation.

Cost savings to medical system.

We all know we have to find ways to maximize health care options on a shoe string budget or the cost of access may soon be beyond the reach of most Americans. This change would save insurance companies money, and, so the thought goes, consumers, too.




Although the FDA has acknowledged they might still require some kind of intermediate step short of requiring a prescription, but more than offering these medications on the shelf, there are still significant safety concerns. Who will warn patients about side effects? Who will make sure patients aren't taking other medications that will cause dangerous interactions?

Insurance coverage.

Insurance companies would no longer pay for your prescriptions or any part of them. You could use an FSA (flexible savings account) if your employer offers one. But considering how expensive triptans are (even the copays can be outrageous), this would be a big drawback for patients and may undermine the intention of increasing access.

The reality of cost savings.

Do cost savings to insurance companies actually translate to cost savings for consumers? This is a controversial question without a straightforward answer. Insurance companies are mostly for-profit businesses. Can we really expect them to forgo profit increases to pass the savings on to their customers? I honestly don't know, and I doubt it.

Added burden to pharmacists.

I don't know if you've noticed, but pharmacists are expected to do a lot more than prepare prescription orders and counsel patients. Navigating the red tape of insurance alone seems to occupy hours of their time each day. Adding another task to their already full plates may not be the right move.

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