Cut FDA red tape so doc­tors can bet­ter treat pa­tients

Walker County Messenger - - Front Page - By Peter J. Pitts

Doc­tors of­ten fail to treat their pa­tients with the most ef­fec­tive medicines -- but it’s not their fault. Is an out­dated FDA reg­u­la­tion to blame?

The FDA pro­hibits phar­ma­ceu­ti­cal com­pa­nies from shar­ing in­for­ma­tion about “of­fla­bel” uses of medicines with physi­cians. Many drugs re­ceived FDA ap­proval for one dis­ease, but also ef­fec­tively treat other ill­nesses that aren’t listed on the of­fi­cial la­bel. Off-la­bel pre­scrib­ing is ac­tu­ally quite com­mon. Physi­cians pre­scribe one in five medicines off-la­bel.

Cur­rently, doc­tors have to make these off-la­bel pre­scrib­ing de­ci­sions based on anec­do­tal ev­i­dence, since they have no ac­cess to drug com­pa­nies’ clin­i­cal trial data. If the FDA were to per­mit greater in­for­ma­tion shar­ing, it would en­able doc­tors to treat pa­tients more ef­fec­tively.

Doc­tors have good rea­son to pre­scribe drugs off-la­bel. Many drugs can treat a wide va­ri­ety of dis­eases. In fact, the av­er­age drug can treat 18 dif­fer­ent ill­nesses, ac­cord­ing to re­searchers from the Uni­ver­sity of Illi­nois at Chicago, Stan­ford Uni­ver­sity, and the Uni­ver­sity of Chicago. For in­stance, the di­a­betes drug Met­formin can treat breast can­cer. And the can­cer drug Bexarotene has the po­ten­tial to treat Alzheimer’s dis­ease.

Doc­tors also pre­scribe drugs of­fla­bel to treat crit­i­cally-ill pa­tients af­ter all ap­proved medicines have failed. For in­stance, many pa­tients with cer­tain au­toim­mune dis­eases don’t re­spond to ap­proved ther­a­pies. As a last-re­sort, doc­tors will pre­scribe these pa­tients Pro­graf, a drug ap­proved to help pre­vent peo­ple’s im­mune sys­tems from re­ject­ing or­gan trans­plants.

When doc­tors pre­scribe drugs off-la­bel, they gather valu­able in­for­ma­tion about how well pa­tients re­spond.

But cur­rent FDA pol­icy re­stricts doc­tors from shar­ing this in­for­ma­tion with each other and with drug man­u­fac­tur­ers. Drug mak­ers are even sub­ject to crim­i­nal pros­e­cu­tion and civil li­a­bil­ity if they dis­cuss un­ap­proved uses of ex­ist­ing drugs.

Com­pa­nies could seek to get their medicines ap­proved for the off-la­bel uses, but the FDA ap­proval process is time-in­ten­sive and costly. In fact, the cost of reap­prov­ing a drug is greater than the prof­its an ap­proval would gen­er­ate, ac­cord­ing to an ar­ti­cle in the Mayo Clinic Pro­ceed­ings. So drug com­pa­nies of­ten choose not to go through the process.

Pol­icy mak­ers in­creas­ingly rec­og­nize the sense­less­ness of pre­vent­ing doc­tors and drug com­pa­nies from shar­ing data. As the new FDA com­mis­sion Scott Gottlieb said, “Pa­tients and physi­cians make the best de­ci­sions when they have ac­cess to as much truth­ful, non­mis­lead­ing, sci­en­tif­i­cally based in­for­ma­tion as pos­si­ble.” In late March, Rep. Mor­gan Grif­fith (R-Va.) in­tro­duced leg­is­la­tion that would make it eas­ier for man­u­fac­tur­ers to share in­for­ma­tion with med­i­cal pro­fes­sion­als on al­ter­na­tive uses for ex­ist­ing med­i­ca­tions.

De­spite sup­port for re­forms, the FDA hasn’t yet re­laxed its pro­hi­bi­tions on data shar­ing.

The FDA should, of course, im­pose re­quire­ments on this in­for­ma­tion shar­ing. For in­stance, if the in­for­ma­tion comes from a clin­i­cal trial, drug com­pa­nies should de­tail the trial’s sam­ple size, lim­i­ta­tions, and method­ol­ogy. If it comes from physi­cians, they should de­scribe pa­tients’ con­di­tions and de­tail how the drug af­fected them.

These re­quire­ments would en­sure that the in­for­ma­tion is clear and ac­cu­rate. But it also would en­sure that doc­tors have the most up-to-date in­for­ma­tion on a drug and the ill­nesses it can treat.

Off-la­bel pre­scrib­ing has al­ready has saved thou­sands of lives. The FDA ought to make it eas­ier for doc­tors and pa­tients to make the most in­formed treat­ment de­ci­sions pos­si­ble.

Peter J. Pitts, a for­mer FDA as­so­ci­ate com­mis­sioner, is pres­i­dent of the Cen­ter for Medicine in the Pub­lic In­ter­est.

Peter Pitts

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