Swine fever thins hep­arin sup­ply

Mass pig deaths in China threaten key drug in US

The Morning Call - - NATION & WORLD - By Anna Edney

A Chi­nese out­break of African swine fever that has killed mil­lions of pigs in the coun­try has also led to falling U.S. supplies of a widely used drug de­rived from the an­i­mals, the anti-clot­ting drug hep­arin.

Hep­arin’s ac­tive in­gre­di­ent is de­rived from pig in­testines. It’s a crit­i­cal drug for heart attack patients and is used in surgery to stop clots. Much of the world’s sup­ply of ac­tive phar­ma­ceu­ti­cal in­gre­di­ent, or API, for the blood thin­ner comes from China, a byprod­uct of the na­tion’s mas­sive pork con­sump­tion.

One ma­jor pro­ducer of hep­arin, a sub­sidiary of Ger­many’s Fre­se­nius SE, said it has started lim­it­ing al­lo­ca­tions of the drug “due to a po­ten­tial short­age of raw in­gre­di­ent,” ac­cord­ing to the Amer­i­can So­ci­ety of HealthSys­tem Phar­ma­cists, a trade or­ga­ni­za­tion that tracks drug short­ages.

“We source from mul­ti­ple sup­pli­ers and ge­ogra­phies to serve our cus­tomers, but the sit­u­a­tion in China is ex­pected to cause API sup­ply con­straints glob­ally for an un­known pe­riod,” Fre­se­nius Kabi said in a July let­ter posted by the phar­ma­cist group.

The U.S. Food and Drug Ad­min­is­tra­tion, which tracks and of­fi­cially de­clares prod­uct short­falls, said that while there were short­ages of some hep­arin prod­ucts, there was suf­fi­cient over­all sup­ply.

“FDA has been mon­i­tor­ing this is­sue since last year and has fol­lowed up with hep­arin sup­pli­ers,” Nathan Arnold, a spokesman for the agency, said in an email Friday. “Although cer­tain pre­sen­ta­tions of hep­arin have been in short­age, the over­all sup­ply con­tin­ues to meet de­mand.”

The global drug sup­ply chain re­lies on raw in­gre­di­ents made around the world and shipped to drug­mak­ers and fin­ish­ers in other coun­tries. That com­plex sys­tem has cre­ated chal­lenges for reg­u­la­tors and health-care sys­tem re­liant on far-flung economies to pro­vide in­gre­di­ents and medicine.

China has lost 150 mil­lion to 200 mil­lion an­i­mals to the con­ta­gious and deadly dis­ease, ac­cord­ing to one es­ti­mate, a dire ex­am­ple of how prob­lems can rip­ple around the world.

The FDA has listed two com­pa­nies, Bax­ter In­ter­na­tional Inc. and Pfizer Inc.’s Hospira, that have short­ages of hep­arin go­ing back to Novem­ber 2017. The agency hasn’t de­clared an of­fi­cial short­age of Fre­se­nius’s prod­uct, though the phar­ma­cists group of­ten sends no­tice of a short­age be­fore the FDA of­fi­cially de­clares one.

Pfizer and Bax­ter haven’t said whether their short­ages have been ex­ac­er­bated by the sit­u­a­tion in China, and didn’t im­me­di­ately re­spond to re­quests for com­ment Friday. Bax­ter has pre­vi­ously blamed its short­age on hur­ri­cane dam­age in Puerto Rico, where it has man­u­fac­tur­ing fa­cil­i­ties.

The Fre­se­nius sub­sidiary, Fre­se­nius Kabi, “has seen a sig­nif­i­cant in­crease in de­mand for cer­tain hep­arin pre­sen­ta­tions as other man­u­fac­tur­ers have ex­pe­ri­enced sup­ply in­ter­rup­tions,” Matthew Kuhn, a com­pany spokesman, said.

Fre­se­nius Kabi sources most of its hep­arin ac­tive in­gre­di­ent out­side of Asia, in­clud­ing in Europe and South Amer­ica, Kuhn said. He also said the FDA re­cently ap­proved ad­di­tional man­u­fac­tur­ing space at one of the com­pany’s U.S. plants to help mit­i­gate a short­age.

The on­go­ing hep­arin short­age car­ries echoes of a cri­sis more than a decade ago, when tainted raw ma­te­ri­als for hep­arin made their way into the U.S. drug sup­ply. The con­tam­i­na­tion re­sulted in the deaths of more than 200 patients, and a con­gres­sional com­mit­tee has raised con­cerns that short­ages could lead sup­pli­ers to cut cor­ners again, putting patients at risk.

The FDA found dur­ing a 2008 in­spec­tion of Bax­ter’s sup­plier in Changzhou, China, that it hadn’t estab­lished a process to re­move im­pu­ri­ties and had used crude hep­arin ma­te­rial from a sup­plier it had once deemed unac­cept­able.

The hep­arin cri­sis led U.S. law­mak­ers to boost the FDA’s abil­ity to in­spect for­eign drug­mak­ers. The House En­ergy and Com­merce Com­mit­tee in­ves­ti­gated and held hear­ings on the con­tam­i­nated blood thin­ner. Rep­re­sen­ta­tives Frank Pal­lone and Greg Walden, the chair­man and top Repub­li­can on the panel re­spec­tively, wrote the FDA in July about the po­ten­tial for a short­age linked to China’s swine fever out­break.

Phar­ma­ceu­ti­cal re­searchers worry the out­break could cause an “un­prece­dented short­age,” Pal­lone and Walden wrote last month to Act­ing FDA Com­mis­sioner Ned Sharp­less.

In 2018, the FDA en­cour­aged devel­op­ment of hep­arin us­ing cow lungs in­stead of pigs. Hep­arin man­u­fac­tur­ers used bovine ma­te­ri­als up un­til the 1990s but stopped given con­cerns over mad cow dis­ease.

“The FDA has been in con­tact with sev­eral com­pa­nies, both do­mes­tic and for­eign, re­gard­ing reintroduc­tion of bovine hep­arin to the U.S. mar­ket,” Arnold, the FDA spokesman, said.

CHINATOPIX 2018

The ac­tive in­gre­di­ent in hep­arin is de­rived from pig in­testines, but China has lost 150 mil­lion to 200 mil­lion pigs to a deadly virus.

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