SAW IN THE OVERSEAS FACTORIES THAT SUPPLY THESE VITAL
INGREDIENTS.
INGREDIENTS. HERE’S STEPHANIE GOSK.
>> Reporter: SOME OF THE MOST
POPULAR GENERIC BLOOD PRESSURE
MEDICATIONS ON THE MARKET.
RECALLED OVER AND OVER.
45 TIMES IN LESS THAN A YEAR.
CERTAIN BATCHES OF VALSARTAN,
LOSA
LOSA LOSARN, AND HERBISARTAN.
LAST YEAR DENISE GOT A CHILLING
LETTER FROM HER PHARMACY.
>> THE IMPURITY IS A PROBABLE
HUMAN CARCINOGEN.
HUMAN CARCINOGEN. >> Reporter: HER BLOOD PRESSURE
MEDICINE, THE ONE SHE TAKES
DAILY, WAS TAINTED WITH A
CHEMICAL LINKED TO CANCER.
>> FORMERLY USED IN THE
PRODUCTION OF ROCKET FUEL.
>> Reporter: ROCKET FUEL.
>> IN MY MEDICINE.
>> Reporter: SHE STARTED LOOKING
INTO IT AND REALIZED SOMETHING
MOST AMERICANS MAY NOT KNOW --
85% OF FACTORIES MAKING RECALL
INGREDIENTS FOR U.S. DRUGS ARE
OUTSIDE THE COUNTRY.
MANY IN INDIA AND CHINA WHERE
PRODUCTION COSTS ARE LOWER.
>> GROWING UP, WE HAD THE SAYING
YOU GET WHAT YOU PAY FOR.
>> Reporter: MA HSU N MATAMAD
SPENT THREE YEARS AS AN
INVESTIGATION INSPECTING
INVESTIGATION INSPECTING PHARMACEUTICAL FACILITIES
PHARMACEUTICAL FACILITIES OVERSEAS.
OVERSEAS. >> YOU’RE ESSENTIALLY THE COP OF
THE PHARMACEUTICAL WORLD.
>> Reporter: HE’S SPEAKING OUT
FOR THE FIRST TIME.
>> AS WE CONTINUE TO PUSH THE
PRICE DOWN, COMPANIES ARE FORCED
TO FIND CREATIVE WAYS TO MAKE
MONEY.
MONEY. >> Reporter: WHICH MEANS WHAT?
>> NOT ADHERING TO OUR LAWS AND
REGULATIONS.
REGULATIONS. >> Reporter: MORE THAN A YEAR
BEFORE THE RECALLS, MOTAMAD
FLAGGED PROBLEMS AT THE SAME
FACTORY IN CHINA THAT MADE
DENISE SHREK’S MEDICATION.
YOU WROTE IN YOUR AUDIT THAT
FACILITIES AND EQUIPMENT ARE NOT
MAINTAINED.
MAINTAINED. ANOMALIES IN TESTING ARE NOT
INVESTIGATED.
INVESTIGATED. YOU FOUND GASKETS THAT WERE
FRAYING, WHITE PARTICULATES AND
RESIDUE ON THE EQUIPMENT.
ALL OF THAT IN A PLACE THAT’S
MAKING DRUGS INTENDED FOR THE
U.S.
U.S. >> CORRECT.
>> CORRECT. >> Reporter: WHAT WAS YOUR
RECOMMENDATION?
RECOMMENDATION? >> OFFICIAL ACTION.
MEANING FDA TAKES INTERVENTION.
>> Reporter: WHAT DID THE FDA
DO?
DO? >> IT WAS DETERMINED THAT
OFFICIAL ACTION WAS NOT
REQUIRED.
REQUIRED. >> Reporter: SO YOU WERE
OVERRULED?
OVERRULED? >> CORRECT.
>> CORRECT. >> Reporter: IT WASN’T JUST THAT
PLANT.
PLANT. TAKE A LOOK AT HIS INSPECTION
REPORT FROM THIS FACILITY IN
INDIA.
INDIA. ALSO MAKING DRUG INGREDIENTS
THAT BECAME PART OF THE RECALL.
>> WE WERE QUITE SHOCKED TO SEE
THAT THEY WERE STAYING UP ALL
NIGHT SHREDDING EXTENSIVE
AMOUNTS OF DOCUMENTS BEFORE OUR
AUDIT.
AUDIT. >> Reporter: THEY WERE UP ALL
NIGHT SHREDDING DOCUMENTS?
>> CORRECT.
>> CORRECT. IT MEANS THERE’S A SUCCESS
"SNL"IC ISSUE.
"SNL"IC ISSUE. >> Reporter: HE SAYS SAYS --
SYSTEMIC ISSUE.
SYSTEMIC ISSUE. >>> HE SAYS THERE ARE TOO FEW
CALLFIED INSPECTORS AND TWO FEW
INSPECTIONS.
INSPECTIONS. IT WASN’T UNTIL A COMPANY
DETECTED A PROBABLE CARCINOGEN
IN ONE OF ITS AGAINST THAT THE
FDA BEGAN ASKING FOR RECALLS.
>> THIS IS TRAGIC, AND IT’S
DEEPLY CONCERNING THAT PEOPLE
WERE EXPOSED.
WERE EXPOSED. THIS SHOULDN’T HAVE HAPPENED.
>> Reporter: SCOTT GOTTLIEB WAS
FDA COMMISSIONER WHEN THE
RECALLS BEGAN AND SAYS IT IS
UNLIKELY THE CONTAMINATION WOULD
HAVE BEEN FOUND ON A ROUTINE
INSPECTION.
INSPECTION. >> IF YOU DIDN’T KNOW TO LOOK
FOR THIS, THIS WOULD HAVE BEEN
VERY HARD TO DETECT.
>> Reporter: IN APE STATEMENT,
THE FDA SAYS IT IS INVESTIGATING
THE ROOT CAUSES OF THE
CONTAMINATION.
CONTAMINATION. AND THAT THE OVERALL CANCER RISK
TO INDIVIDUAL PATIENTS IS SMALL.
LITTLE COMFORT FOR DENISE SHREK.
>> I HAVE A 13-YEAR-OLD SON
WHO’S WORRIED ABOUT HIS MOM, YOU
KNOW.
KNOW. HE SHOULDN’T HAVE TO WORRY ABOUT
A PROBABLE CARCINOGEN IN YOUR
MEDICATION.
MEDICATION. >> Reporter: MATAMAD WHO LEFT
THE FDA IN 21st017 WARNS THE
PROBLEM IS MUCH BIGGER THAN JUST
BLOOD PRESSURE PILLS.
>> AFTER SEEING THIS RECALL, I
WONDERED TO MYSELF WHAT ABOUT
ALL THE OTHER DRUGS THAT YOU
HAVEN’T TESTED.
HAVEN’T TESTED. >> Reporter: NOT JUST THESE
PLANTS.
PLANTS. >> CORRECT.
>> CORRECT. THIS IS FROM MY SPECK, THIS IS
ONLY THE TIP OF THE ICEBERG.
>> Reporter: THE GENERIC
DRUGMAKERS ASSOCIATION TOLD US
THEIR DRUGS ARE SAFE REGARDLESS
OF WHERE THEY ARE MADE, AND
THEY’RE WORKING CLOSELY WITH THE
FDA.
FDA. THE DRUG COMPANY IN CHINA ALSO
SAYS IT’S WORKING WITH
REGULATORS, AND, LESTER, AS FAR
AS THAT COMPANY IN INDIA WHERE
THEY WERE SHREDDING DOCUMENTS,
THEY DID NOT RESPOND TO OUR
QUESTIONS.
QUESTIONS. >> ALL RIGHT.
FOR ALL THE PEOPLE ON THESE
BLOOD PRESSURE MEDICATIONS,ING W
SHOULD THEY DO?
>> Reporter: THE FDA SAYS DO NOT
ABRUPTLY STOP TAKING THE
MEDICATIONS.