Un­nec­es­sary com­pro­mise

Slow national drug trace­abil­ity ef­forts cut down states’ faster ef­forts

Modern Healthcare - - OPINIONS / EDITORIALS - MER­RILL GOOZNER Edi­tor

It took the U.S. 8½ years to land a man on the moon. Nearly a half cen­tury later, it’s go­ing to take the same U.S. more than a dozen years be­fore ac­com­plish­ing the seem­ingly mun­dane task of be­ing able to elec­tron­i­cally trace fake or tainted drugs back to their source of sup­ply. You would think that af­ter 81 deaths and nearly 800 se­ri­ous in­juries from poi­sonous Chi­nese in­gre­di­ents in hep­arin, re­peated ef­forts to ped­dle fake Avastin to on­col­ogy prac­tices, and nu­mer­ous in­stances where coun­ter­feit or stolen ver­sions of ator­vas­tatin (Lip­i­tor) en­tered the sup­ply chain—all in just the past six years—there would be a lit­tle more sense of ur­gency in Congress.

Last week, the House of Rep­re­sen­ta­tives passed leg­is­la­tion that would re­quire man­u­fac­tur­ers by 2015 to place track­able bar codes on ev­ery drug pack­age they ship. But the bill doesn’t re­quire whole­salers or pharmacies to adopt a com­put­er­ized trac­ing sys­tem that can make use of those bar codes for an­other dozen years—and even then only if the Food and Drug Ad­min­is­tra­tion comes up with a rule re­quir­ing them to do so. Given the FDA’s track record on end­lessly de­lay­ing the im­po­si­tion of a univer­sal iden­ti­fier on ev­ery im­plantable de­vice, there’s no rea­son to be­lieve a ser­vice­able “track-and-trace” sys­tem will be in place even then.

The Se­nate ver­sion of the bill isn’t much bet­ter. It re­quires trace­abil­ity by whole­salers and pharmacies, but not un­til 10 years af­ter en­act­ment of the law.

There is one thing that both bills have in com­mon. They would both pre­empt state laws that move more rapidly to­ward re­quir­ing the drug sup­ply chain to adopt track-and-trace. While a few states have passed leg­is­la­tion re­quir­ing trace­abil­ity, Cal­i­for­nia, which of­ten leads the na­tion in adopt­ing new reg­u­la­tions, is slog­ging to­ward a 2016 dead­line. That’s hardly a rapid pace since its law, passed in 2004, has been de­layed many times be­cause of in­dus­try op­po­si­tion.

And that’s the part that is hard to un­der­stand. A group called the Phar­ma­ceu­ti­cal Dis­tri­bu­tion Se­cu­rity Al­liance os­ten­si­bly backs the goals and time­lines in both bills. But its real goal is pre­empt­ing state laws such as Cal­i­for­nia’s, which would re­sult in a patch­work quilt of reg­u­la­tions that could ac­tu­ally in­ter­fere with an ef­fec­tive, national track-and-trace sys­tem. That’s a le­git­i­mate con­cern. But the other is­sues be­ing raised by the take-it-slow al­liance—will the tech­nol­ogy work; will it cost too much; will it lead to drug short­ages—would be eas­ily re­solved if there were a national will to get the job done.

The global phar­ma­ceu­ti­cal mar­ket­place cries out for an in­ter­na­tional track-and-trace sys­tem. Al­ready, more than 80% of the ac­tive phar­ma­ceu­ti­cal in­gre­di­ents in drugs used in the U.S. come from abroad, as do more than 40% of fin­ished prod­ucts. Within the U.S., there is a grow­ing gray mar­ket for drugs where whole­salers rapidly ex­change lots of soon-to-ex­pire med­i­ca­tions. New re­tail out­lets such as In­ter­net pharmacies and mass-mar­ket retailers are chal­leng­ing tra­di­tional pharmacies and mak­ing it much more dif­fi­cult to track drugs when they have to be re­called.

The ros­ter of 25 com­pa­nies and trade as­so­ci­a­tions in the take-it-slow PDSA in­cludes phar­ma­ceu­ti­cal and biotech­nol­ogy drug man­u­fac­tur­ers, whole­sale dis­trib­u­tors, pharmacies and the third-party lo­gis­tics providers. Notably miss­ing are hos­pi­tals, physi­cian prac­tices and the pa­tients who ac­tu­ally use the drugs. Con­sumer groups such as Con­sumers Union and pub­lic health ad­vo­cates such as Trust for Amer­ica’s Health have re­luc­tantly en­dorsed the Se­nate ver­sion of the bill as a nec­es­sary po­lit­i­cal com­pro­mise to get some­thing done.

If we had a Congress that truly cared about the safety and pu­rity of the U.S. drug sup­ply, such com­pro­mises wouldn’t be nec­es­sary.

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