The FDA says it is looking for change in the OTC market that could help move more drugs from prescription to over-the-counter status.
“The requirement to obtain a prescription for appropriate medication (and to make one or more visits to a practitioner) may contribute to under-treatment of certain common medical conditions,” the agency said in the February 23 Federal Register.
FDA says it is looking for information about the technology the industry has on tap that could help patients get greater access without increasing possible risk. These options may include an over-the-counter-but-through-the-pharmacist approach in which a patient doesn't require a prescription, but does need to consult the pharmacist “to ensure appropriate nonprescription use.”
The agency said it is open to allowing FDA-approved diagnostics to match patients to treatment options, but notes that even rigorous pharmacy tutorials or tech have limits and is looking to pinpoint the types of drugs that could be safely used without a prescription.
Success among the prescription-to-OTC categories has been varied. Merck has failed several times to get OTC approval for its statin Mevacor, because surveys shows patients would take the drug even if they didn't need it, and analysts have been temperate in their assessment of an OTC version of Pfizer's Lipitor.
The allergy category has done fairly well, with Sanofi's Allegra (fexofenadine) getting OTC approval in 2011. McNeil's Zyrtec (cetirizine) made the switch in 2008, and Merck's Claritin (loratadine) was put in consumer's prescription-free reach in 2002.