Early opi­oid in­ac­tion by FDA re­quires big push now

Chief ad­vo­cates for pre­scrip­tion lim­its as over­doses soar

The Commercial Appeal - - Front Page -

USA TO­DAY WASH­ING­TON Chris Barth fell hard for the painkiller Per­co­cet the first time he tried it at 15. It was an on-again, off-again ro­mance for nearly two decades, fu­eled in part by pre­scrip­tions for his own in­juries and the oc­ca­sional opi­oid swiped from his par­ents’ medicine cab­i­net.

That was the 1990s and 2000s, how­ever, when lit­tle was known about the deadly con­se­quences of ad­dic­tion to opi­oids in­clud­ing Per­co­cet, a brand­name ver­sion of oxy­codone and ac­etaminophen. So when Barth’s mother got a 30-day sup­ply of Per­co­cet re­cently for a knee re­place­ment that only re­quired three days of the drug, Barth was shocked that was still done.

Food and Drug Ad­min­is­tra­tion Com­mis­sioner Scott Got­tlieb, now in his third stint at the agency, says he doesn’t want to re­peat the mis­takes the agen­doc­tors cy made in the 2000s when it failed to reg­u­late opi­oids more. He’s ad­vo­cat­ing shorter opi­oid pre­scrip­tions, in­creas­ing over­sight of highly ad­dic­tive im­me­di­ate re­lease opi­oid for­mu­las and tight­en­ing re­quire­ments for abuse-de­ter­rent for­mu­las.

“The type of ac­tion we need to take to fi­nally (ad­dress) this cri­sis is go­ing to be far more dra­matic than it would had to do if we made cer­tain de­ci­sions years ago,” Got­tlieb, a physi­cian, told a Na­tional Acad­emy of Medicine con­fer­ence last week.

That’s a “very can­did” ad­mis­sion that ac­knowl­edges Got­tlieb was at the FDA “at a time when opi­oid use was ris­ing rapidly in this coun­try and be­ing very in­ap­pro­pri­ately mar­keted,” says Josh Sharf­stein, a doc­tor who was the FDA’s prin­ci­pal deputy com­mis­sioner in the Obama ad­min­is­tra­tion.

“Scott was quick out of the gate to take some steps on opi­oids,” says Sharf­stein, now a pro­fes­sor and an as­so­ci­ate dean at Johns Hop­kins Univer­sity’s Bloomberg School of Pub­lic Health. “He rec­og­nizes there’s a lot more to do be done at the FDA.”

About 64,000 peo­ple died of all drug over­doses last year, up from less than 20,000 in 1999, ac­cord­ing to the Na­tional In­sti­tute on Drug Abuse. Nearly 35,000 peo­ple over­dosed on heroin and other opi­oids in 2015, the lat­est year avail­able. Every day, 62 peo­ple die be­cause of pre­scrip­tion opi­ods. Many peo­ple with sub­stance abuse dis­or­der have switched from opi­oid pain pills to heroin be­cause it’s eas­ier to get and af­ford.

What’s be­ing done:

Sev­eral states have passed laws that would cap first-time opi­oid pre­scrip­tions at seven days, and CVS an­nounced last month that it would limit ini­tial opi­oid pre­scrip­tions to a week.

The FDA now plans to reg­u­late th­ese drugs as they do the ex­tended-re­lease for­mu­las. That means drug mak­ers have to make train­ing avail­able to that in­cludes safe pre­scrib­ing and non-opi­oid al­ter­na­tives.

FDA is pre­par­ing for an ex­pected on­slaught of generic ver­sions of th­ese drugs, which cur­rently don’t ex­ist and will re­lease guid­ance for drug mak­ers soon.

Perry Lewis, vice pres­i­dent of in­dus­try re­la­tions at elec­tronic prior autho­riza­tion com­pany CoverMyMeds, has seen both sides of the de­bate in of­ten painful ways. His son Chan­dler, now 28, was ad­dicted to a va­ri­ety of opi­oids af­ter try­ing pain med­i­ca­tion he found at home.

“It’s gru­el­ing. We felt like fail­ures,” says Lewis. “It breaks fam­i­lies as so many peo­ple don’t have the sup­port.”

His com­pany’s soft­ware speeds up prior au­tho­riza­tions from about five days to be­tween sec­onds and a day. He wor­ries road­blocks for pre­scrip­tions could cause lit­er­ally painful de­lays for many pa­tients.

“We all rec­og­nize there’s an opi­oid prob­lem, but are we go­ing too far in putting in re­stric­tions on those who would need it in a timely man­ner?” he asked.

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