REG­U­LA­TION:

Feds move to ease sup­plies while prose­cut­ing re­sellers

Modern Healthcare - - MODERN HEALTHCARE - Jaimy Lee

Feds move to ad­dress grow­ing drug short­age

Pa­tients and gov­ern­ment agen­cies are us­ing a grow­ing ar­ray of tools to mit­i­gate the scope and ef­fects of drug short­ages, which con­tinue to rise. The Food and Drug Ad­min­is­tra­tion re­leased draft guid­ance last week that builds on an ex­ec­u­tive or­der Pres­i­dent Barack Obama is­sued in Oc­to­ber to ad­dress the grow­ing prob­lem.

Com­pa­nies that are the sole source of cer­tain drugs should be re­quired to no­tify the gov­ern­ment of any man­u­fac­tur­ing dis­rup­tions, ac­cord­ing to the guid­ance. The FDA said it “orig­i­nally in­ter­preted this re­quire­ment to ap­ply only to per­ma­nent man­u­fac­tur­ing dis­con­tin­u­ances” rather than other tem­po­rary man­u­fac­tur­ing sus­pen­sions.

The FDA also an­nounced moves to ease the short­ages of two can­cer drugs, ap­prov­ing methotrex­ate from a new man­u­fac­turer and the im­por­ta­tion of Lipo­dox, an un­ap­proved drug in the U.S., to re­place Doxil. The agency is show­ing an “in­creased, new flex­i­bil­ity,” said Al­bert Wertheimer, a pro­fes­sor of phar­macy at Tem­ple Univer­sity in Philadel­phia.

Those moves alone won’t al­lay con­cerns over the short­ages, which have wors­ened over the last six months, said Michael Co­hen, pres­i­dent of the In­sti­tute for Safe Med­i­ca­tion Prac­tices.

There were 267 re­ported drug short­ages in 2011, up 26.5% com­pared with 211 in 2010 and up 281.4% com­pared with 70 in 2006, ac­cord­ing to the Univer­sity of Utah Drug In­for­ma­tion Ser­vice.

“This is not a re­solved sit­u­a­tion,” Co­hen said. “We’ve got a long way to go.”

The short­ages have turned a spot­light on the rel­a­tively un­known mar­ket of sec­ondary drug dis­trib­u­tors, which of­ten sell drugs at prices that are higher than what a hospi­tal with a dis­count from its group pur­chas­ing or­ga­ni­za­tion may pay. Al­le­ga­tions of price­goug­ing prompted Rep. Eli­jah Cum­mings (D-MD.) to launch an in­ves­ti­ga­tion into sev­eral dis­trib­u­tors.

Last week, the U.S. Jus­tice Depart­ment an­nounced the res­o­lu­tion of a case sug­gest­ing the gov­ern­ment is us­ing crim­i­nal en­force­ment to stem the flow of drugs into the sec­ondary mar­ket. A Florida physi­cian pleaded guilty to one count of con­spir­acy to com­mit mail and wire fraud as part of a scheme to buy and re­sell a prostate can­cer drug to at least two drug whole­salers in Ohio and New Jer­sey.

Dr. Michael Schoenwald of Hol­ly­wood, Fla., sold Lupron to an­other in­di­vid­ual, who cre­ated false drug pedi­grees and sold the drugs to whole­salers from 2007 to 2009, ac­cord­ing to doc­u­ments filed in Cincin­nati.

As­sis­tant U.S. At­tor­ney Anne Porter said it was the first case in which a physi­cian pleaded guilty to a drug diver­sion scheme with the U.S. at­tor­ney’s of­fice in Cincin­nati. She de­clined to say whether the of­fice is pur­su­ing sim­i­lar in­ves­ti­ga­tions.

Also this month, 25 pa­tients filed a law­suit in Washington against HHS, the FDA, and the Na­tional In­sti­tutes of Health, al­leg­ing that the way the FDA han­dled short­ages of Fabrazyme, a drug used to treat a rare ge­netic dis­ease and which costs $200,000 for a year’s sup­ply, and aqua­sol A, a drug used to treat vi­ta­min A de­fi­ciency, vi­o­lated the pa­tients’ con­sti­tu­tional rights.

The plain­tiffs al­lege that Fabrazyme pa­tients, who pur­chase the drug di­rectly from Gen­zyme Corp., the drug’s only man­u­fac­turer in the U.S., re­ceived di­luted doses af­ter the short­age be­gan in 2009. They al­lege the com­pany has pro­vided full doses to pa­tients in Europe, where there is a com­pet­ing drug. The pa­tients say that the courts should su­per­vise the al­lo­ca­tion of a drug in short sup­ply and that FDA li­censes is­sued to drug com­pa­nies that cause short­ages should be in­val­i­dated and the pa­tents de­clared un­en­force­able.

“The FDA stepped back when there was a short­age and let the cor­po­ra­tions make all the med­i­cal de­ci­sions for the pa­tient,” said Allen Black, the pa­tients’ lawyer. Four­teen plain­tiffs filed a re­lated suit in Bos­ton last year against Gen­zyme and the Mount Si­nai School of Medicine, New York, which owns the patent for Fabrazyme. Black said a sec­ond suit will be filed by about 50 plain­tiffs in New York against both or­ga­ni­za­tions this year.

Although the Fabrazyme case dif­fers from that of many of the other drugs in short sup­ply—most are generic in­jectibles pur­chased by hos­pi­tals and GPOS, not di­rectly by pa­tients—black said that he ex­pects to see other law­suits re­lated to short­ages. “The com­mon de­nom­i­na­tor for all of the short­ages is FDA li­censes,” he said.

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