42valsartan from Huahai since 2012. Clausen, the FDA inspec-
tor who visited Huahai last summer, detailed in her report
what happened next. After the shipments arrived in Stein,
Switzerland, Novartis’s scientists conducted tests for residual
solvents. What they found worried them: a spike in the data
that signaled an impurity. Novartis told executives at Huahai
about the spike in June. Clausen wrote in her report that
Huahai knew about the data peak and considered it “noise.”
Novartis sent samples to another company for more ex-
tensive testing. It then informed Huahai that the impurity the
company had ignored, and that no other customer seemed to
have noticed, was NDMA. Novartis says it notified health reg-
ulators of the contamination and recalled its generic valsartan
in Europe and Canada.
A probable carcinogen in a medication taken by millions
of people manufactured in a factory the FDA knew had prob-
lems was a crisis for the agency. Staff scrambled to verify
their own test to detect NDMA. The agency says industrial
chemists and regulators around the world were surprised
to find the toxin in valsartan. They knew there was a risk
NDMA could form but didn’t think it could survive.
Huahai finally developed a test to detect the toxin—some-
thing it should have done when it made the manufactur-
ing change. “They certainly should have caught it, and they
should have modified the procedure to correct it,” says Kevin
Schug, an analytical chemistry professor at the University
of Texas at Arlington who’s done extensive research on the
testing of pharmaceuticals. The company left no records oftrying to do either. “Any well-trained analytical chemist would
know to check,” says Gortler, the former FDA medical offi-
cer. “If it’s not intentional, it’s incompetence. At some point,
those are the same.”
Gortler says if regulators can’t trust manufacturers to catch
such impurities, the FDA should inspect the drugs before
they enter the U.S. That the agency tests so few is another
problem. “It is totally unacceptable,” he says. “It is titani-
cally unacceptable.”
It seems that none of Huahai’s customers anywhere looked
for impurities in valsartan until Novartis did—or if they did,
they didn’t identify what they found. “We in the industry
are responsible for testing,” says Rick Sachleben, an organic
chemist and pharmaceutical consultant. “If we’re buying
stuff, we have to make sure they’re making it right.”
To gauge what testing might turn up, consider
Valisure LLC, an online pharmacy in New Haven, Conn., that
opened in 2018 and tests every drug it orders. It’s rejected
more than 10% of the medication batches it’s purchased,
according to CEO David Light. Grounds for rejection could
be a drug not having the proper amount of active ingre-
dient, or not dissolving as it’s supposed to, or containing
impurities. Valisure does sell two versions of valsartan, from
Alembic Pharmaceuticals Ltd. in India and Jubilant Cadista
in Maryland.
Light says he’s spoken with people in the industry about
his findings. “The overwhelming response is, ‘We know
there’s a problem, but it’s not our problem,’ ” he says. QILAI SHEN/BLOOMBERG42An FDA inspector rec-
ommended issuing
a warning letter to
Huahai’s Linhai factoryBloomberg Businessweek September 16, 2019valsartanfromHuahai since 2012. Clausen, the FDA inspec-
tor who visited Huahai last summer, detailed in her report
what happened next. After the shipments arrived in Stein,
Switzerland, Novartis’s scientists conducted tests for residual
solvents. What they found worried them: a spike in the data
that signaled an impurity. Novartis told executives at Huahai
about the spike in June. Clausen wrote in her report that
Huahai knew about the data peak and considered it “noise.”
Novartis sent samples to another company for more ex-
tensive testing. It then informed Huahai that the impurity the
company had ignored, and that no other customer seemed to
have noticed, was NDMA. Novartis says it notified health reg-
ulators of the contamination and recalled its generic valsartan
in Europe and Canada.
A probable carcinogen in a medication taken by millions
of people manufactured in a factory the FDA knew had prob-
lems was a crisis for the agency. Staff scrambled to verify
their own test to detect NDMA. The agency says industrial
chemists and regulators around the world were surprised
to find the toxin in valsartan. They knew there was a risk
NDMA could form but didn’t think it could survive.
Huahai finally developed a test to detect the toxin—some-
thing it should have done when it made the manufactur-
ing change. “They certainly should have caught it, and they
should have modified the procedure to correct it,” says Kevin
Schug, an analytical chemistry professor at the University
of Texas at Arlington who’s done extensive research on the
testing of pharmaceuticals. The company left no records oftrying to do either. “Any well-trained analytical chemist would
know to check,” says Gortler, the former FDA medical offi-
cer. “If it’s not intentional, it’s incompetence. At some point,
those are the same.”
Gortler says if regulators can’t trust manufacturers to catch
such impurities, the FDA should inspect the drugs before
they enter the U.S. That the agency tests so few is another
problem. “It is totally unacceptable,” he says. “It is titani-
cally unacceptable.”
It seems that none of Huahai’s customers anywhere looked
for impurities in valsartan until Novartis did—or if they did,
they didn’t identify what they found. “We in the industry
are responsible for testing,” says Rick Sachleben, an organic
chemist and pharmaceutical consultant. “If we’re buying
stuff,wehavetomakesurethey’remakingit right.”
To gauge what testing might turn up, consider
ValisureLLC, an online pharmacy in New Haven, Conn., that
opened in 2018 and tests every drug it orders. It’s rejected
more than 10% of the medication batches it’s purchased,
according to CEO David Light. Grounds for rejection could
bea drugnothavingtheproperamountofactiveingre-
dient,ornotdissolvingasit’ssupposedto,orcontaining
impurities.Valisuredoesselltwoversionsofvalsartan, from
Alembic Pharmaceuticals Ltd. in India and Jubilant Cadista
in Maryland.
Light says he’s spoken with people in the industry about
his findings. “The overwhelming response is, ‘We know
there’s a problem, but it’s not our problem,’ ” he says. QILAI SHEN/BLOOMBERG42
An FDA inspector rec-
ommended issuing
a warning letter to
Huahai’s Linhai factoryBloomberg Businessweek September 16, 2019