Efforts to convince the FDA toswitch Mevacor from prescription toOTC status suffered a key setback whenan FDA advisory committee decidedthat the risks associated with the cholesterol-lowering drug were too complicatedto allow patients to self-medicate.
In voting 20 to 3 against endorsingthe switch, the committee dealt asevere blow to the hopes of the drug's2 manufacturers—Merck and Johnson& Johnson—as well as to the AmericanPharmacists Association's (APhA's) supportfor designating Mevacor as a"Pharmacy Care OTC."
In their application seeking FDAapproval to position Mevacor (lovastatin)as the first statin drug availablewithout a prescription, the manufacturershave proposed that the OTC versionbe distributed only to outlets witha pharmacy.
That plan would have meshed neatlywith APhA's plan to encourage thecreation of a new "Pharmacy CareOTC"category of nonprescriptionmedicines available only in pharmacieson the open shelf with other OTCmedications.
"What is different with PharmacyCare OTCs is the availability of thepharmacist and the marketing, productplacement, and pharmacist preparationto support consumer/pharmacistinteraction,"APhA said in astatement to the FDA advisory panel.
This approach "would not only provideconsumers with greater access toimportant medications that can benefittheir health, but would also ensure thatconsumers have access to the medicationexpertise of pharmacists to help themuse the medications appropriately."
In rejecting this rationale, the advisorygroup concluded that physicianmonitoring of patients taking statinscontinues to be necessary.
Mr. Rankin is a freelance medical writer.