Efforts to convince the FDA to switch Mevacor from prescription to OTC status suffered a key setback when an FDA advisory committee decided that the risks associated with the cholesterol- lowering drug were too complicated to allow patients to self-medicate.
In voting 20 to 3 against endorsing the switch, the committee dealt a severe blow to the hopes of the drug's 2 manufacturersMerck and Johnson & Johnsonas well as to the American Pharmacists Association's (APhA's) support for designating Mevacor as a "Pharmacy Care OTC."
In their application seeking FDA approval to position Mevacor (lovastatin) as the first statin drug available without a prescription, the manufacturers have proposed that the OTC version be distributed only to outlets with a pharmacy.
That plan would have meshed neatly with APhA's plan to encourage the creation of a new "Pharmacy Care OTC"category of nonprescription medicines available only in pharmacies on the open shelf with other OTC medications.
"What is different with Pharmacy Care OTCs is the availability of the pharmacist and the marketing, product placement, and pharmacist preparation to support consumer/pharmacist interaction,"APhA said in a statement to the FDA advisory panel.
This approach "would not only provide consumers with greater access to important medications that can benefit their health, but would also ensure that consumers have access to the medication expertise of pharmacists to help them use the medications appropriately."
In rejecting this rationale, the advisory group concluded that physician monitoring of patients taking statins continues to be necessary.
Mr. Rankin is a freelance medical writer.
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