FDA mulls widely used drugs be­ing avail­able sans pre­scrip­tions

The Washington Times Daily - - Nation - BYMATTHEW PER­RONE

Some of the most widely used pre­scrip­tion drugs, in­clud­ing those to treat choles­terol and high blood pres­sure, could be freely avail­able over the counter un­der a new pro­posal be­ing weighed by gov­ern­ment reg­u­la­tors.

Food and Drug Ad­min­is­tra­tion of­fi­cials said Wed­nes­day they are con­sid­er­ing waiv­ing pre­scrip­tion re­quire­ments for cer­tain drugs used to treat ail­ments such as di­a­betes, asthma and mi­graine.

Driv­ing the move is a wave of com­puter tech­nol­ogy, in­clud­ing touch-screen kiosks found in phar­ma­cies, de­signed to help pa­tients self-di­ag­nose com­mon dis­eases.

FDA reg­u­la­tors told re­porters that eas­ing ac­cess to ob­tain cer­tain med­i­ca­tions could help ad­dress un­der­treated epi­demics like di­a­betes, a lead­ing cause of heart dis­ease and stroke. Of the more than 25 mil­lion Amer­i­cans with di­a­betes, an es­ti­mated 7 mil­lion are not di­ag­nosed and there­fore are not treated.

“These are dis­cus­sions that need to start hap­pen­ing as we think about peo­ple’s health needs and how to im­prove ac­cess,” said FDA Com­mis­sioner Dr. Mar­garet Ham­burg said.

The over-the-counter switch is one of sev­eral FDA pro­pos­als aimed at in­creas­ing ac­cess to es­tab­lished drugs or speed­ing up ap­proval of ex­per­i­men­tal med­i­ca­tions.

Af­ter years of high-pro­file drug safety cases in which the FDA re­stricted ac­cess to cer­tain med­i­ca­tions, the agency is in­creas­ingly high­light­ing its ef­forts help mak­ers get new, in­no­va­tive drugs on the mar­ket. Some Re­pub­li­can-backed pro­pos­als in Congress would even change FDA’S mis­sion state­ment, re­quir­ing the agency to en­cour­age med­i­cal in­no­va­tion and job cre­ation.

“We’re not talk­ing about aban­don­ing stan­dards for safety and ef­fi­cacy, we’re talk­ing about lever­ag­ing op­por­tu­ni­ties in sci­ence so we can do a more-ef­fec­tive job as reg­u­la­tors and also im­prove the drug de­vel­op­ment process,” Dr. Ham­burg said.

Over the years, the FDA has ap­proved the switch of sev­eral high-pro­file pre­scrip­tion drugs to over-the-counter use. In 2003, the FDA cleared Prilosec, an over-the-counter ver­sion of the block­buster As­trazeneca heart­burn drug Nexium.

The FDA only ap­proves such changes if stud­ies show that pa­tients can safely take the drug af­ter read­ing the pack­age la­bel­ing. Un­der the in­dus­try-backed pro­posal, drug-mak­ers could use elec­tronic ques­tion­naires, di­ag­nos­tic de­vices such as blood pres­sure mon­i­tors and other com­puter-as­sisted tech­nol­ogy to guide pa­tients.

In some cases, pa­tients would still need to see a doc­tor to ob­tain an ini­tial pre­scrip­tion be­fore get­ting over-the­counter re­fills. In other cases, pa­tients would need to speak with a phar­ma­cist but not need a pre­scrip­tion.

The agency also pre­dicts a num­ber of ben­e­fits from de­creas­ing doc­tor vis­its.

“Elim­i­nat­ing or re­duc­ing the num­ber of rou­tine vis­its could free up pre­scribers to spend time with more se­ri­ously ill pa­tients, re­duce the bur­dens on the al­ready over­bur­dened health care sys­tem and re­duce health care costs,” the agency states in re­cent fed­eral no­tice about the pro­posal.

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