Whether it’s allergy medications, treatments for erectile dysfunction or high cholesterol, the issue of Rx-to-OTC switching is complicated, important – and timely.
And not just because of certain high profile LOE dates.
A new draft guidance (issued Sept. 16th) provides a valuable resource for those thinking about proceeding with OTC switches based on self-selection studies. The Pink sheet opines that “support of Rx-to-OTC switches reflects FDA's interest in drilling down for greater insight into consumers' thought processes.”
“Some experts contend there are no more switches for conditions that are relatively easy to self-diagnose, meaning the bar to convince the agency that consumers can appropriately self-select for an Rx drug in an OTC setting has been raised.”
Can a patient self-diagnose and self-dose? Do symptoms hide another, potentially more serious, underlying condition? And what of safety concerns?
Does this open the door for a so-called “behind the counter” (BTC) category? CDER Director Janet Woodcock has spoken out in favor of such strategies since they would allow switch candidates with greater self-selection obstacles to be available without a prescription.
A BTC category would almost certainly reopen the conversation about the “statin quo.”
In 2005, an FDA advisory panel voted down a bid by Merck & Co. and Johnson & Johnson to sell Mevacor, a cholesterol-lowering drug, without a prescription. Several panel members said the FDA should consider establishing a behind-the-counter system that would allow consumers to purchase Mevacor from pharmacists much like the British are allowed to purchase Merck's Zocor, another cholesterol-lowering drug. Most panel members said that, if such a system existed in the U.S., they would have voted to allow Mevacor to be sold without a prescription.
The FDA noted that other countries with behind-the-counter status include Australia, Canada, New Zealand, Denmark, Germany, Italy, the Netherlands, Sweden and Switzerland.
This is an important debate as well as a "teaching moment" for American pharmacists to communicate the crucial role they play in 21st century American health care.
