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Lilly Procedure Prompts FDA Concern

May 8, 2002 | WRTV TheIndyChannel.com

INDIANAPOLIS-BASED ELI LILLY AND COMPANY HAS MADE NO SECRET ABOUT IT'S QUALITY CONTROL PROBLEMS.

THE FDA IS STALLING THE RELEASE OF AT LEAST ONE NEW DRUG, UNTIL ALL IS WELL AT THE PLANTS... AND WITHOUT THAT NEW MEDICINE, THE COMPANY IS TAKING A FINANCIAL HIT.

SO WHY IS THE GOVERNMENT CONCERNED, AND WHAT DOES IT MEAN TO YOU? KRISTI TEDESCO HAS THIS RTV6 INVESTIGATION.

THIS WAS A DIFFICULT INVESTIGATION BECAUSE PEOPLE WERE VERY RELUCTANT TO TALK.

THE FDA TURNED DOWN OUR REQUEST FOR AN ON-CAMERA INTERVIEW ... BECAUSE THE INSPECTIONS AT ELI LILLY ARE ONGOING ... BUT WE *DID* GET A LOT OF INFORMATION FROM THIS, THE FDA INSPECTION REPORTS.

IN THESE PAGES, THERE WAS *ONE* THING THAT CAUGHT THE EYE OF OUR HEALTH EXPERTS ...

IT HAS TO DO WITH ELI LILLY'S *LIQUID* PRESCRIPTIONS.

It's a giant, with more than 15-thousand Indiana employees... More than 40-thousand workers worldwide. Eli Lilly products are sold in 158 countries. And, last year, the pharmaceutical company spent more than 8-and-a-half million dollars *each work day* on research and development. Giving life to new drugs... in plants that have recently come under scrutiny.

SIDNEY TAUREL: Inspectors are visiting a number of our facilities. Tippecanoe and here... what we call building 100 and building 105.

SIDNEY TAUREL: Our number one task is to raise our quality of our manufacturing operations to the highest standards.

Last month, Eli Lilly's Chairman and CEO made it clear... his company will work diligently to improve quality control-- in Indianapolis and around the globe. There have been three rounds of inspections in the last year and a half... and some of the quality issues *uncovered* were *detailed* in this, most recent, November 2001 FDA report. Some of the 32 pages have been blacked out... to cover confidential Eli Lilly data ... but the Federal observations are still there. The FDA found, company computers are not secure... records are flawed... and some employees aren't following proper procedure. The FDA writes that Lilly personnel were "...found to have innaccurately recorded the dates they had actually performed various activities..." and that "recording practices... were in conflict with the firm's current procedures..." These types of complaints make up more than half of all the FDA observations.

Experts we spoke with say it's the FDA's job to be nit-picky... but there is one inspection point that's causing concern. According to the FDA, Eli Lilly randomly samples their medication. It's for quality control. This is a common practice. Cancer drugs, like Gemzar... and these Insulin medicines, like this Humulin L Lente... commonly used. Well, when a bad vial shows up, the FDA says, Eli Lilly throws away only part of the batch... not the whole thing... which raises the question. Could some vials... with the *wrong amount* of medicine... be making it to your pharmacy shelves?

We asked Chris Fausel, a pharmacist with the IU Cancer Center... and Joni Carrol, a registered nurse and certified diabetes educator, to give their thoughts.

JONI CARROL/R.N. & DIABETES EDUCATOR: If every vial of insulin that comes out of that batch is not effective to control my client's blood sugar, it absolutely gives me pause.

CHRIS FAUSEL/PHARMACIST-IU CANCER CENTER: When you're treating cancer it's imperative that each patient gets the exact amount of drug that they're prescribed and even if one vial is off, then the patient's care may be compromised.

Eli Lilly says you shouldn't be concerned... because its products are safe.

ED WEST/ELI LILLY SPOKESMAN: We're working pretty hard with the FDA to resolve all the outstanding manufacturing issues. We need to do that for a lot of reasons... not the least of which is to ensure everybody that gets a Lilly medicine that it's right, fully potent and high quality.

Eli Lilly told the FDA... the company is "...undertaking a complete assessment of the rejection rates..." and will "...eliminate partial lot rejections for insulin items..." In the meantime, the pharmaceutical company is worried about a shortage of insulin...so the company said "...insulin suspension items will continue to be released in the interim using the existing (blacked out) procedures..." When it comes to that insulin quality... Eli Lilly says...

ED WEST/ELI LILLY SPOKESMAN: Patients can rest assured that their Lilly insulin is gonna be just what they need.

It appears the FDA isn't too concerned about quality at the Lilly plants. Inspectors have shut down *other* plants for public health reasons. Companies like Merck... which makes vaccines for Hepatitis, Measles, Mumps & Rubella. It had to temporarily close shop after FDA inspections. Without getting specific, the FDA told RTV6, weaknesses are being closely watched. Quote, "If we find problems in any plant... and the plant continues to operate... it's taking corrective actions to fix the problem. We would not allow products out that would hurt the public. We wouldn't compromise the public's health." According to the FDA, the size of the inspection documents... and the number of inspections... is not unusual, especially when it concerns a company with so many products.

((SIDNEY TAUREL: Let me be clear, Lilly has no more important priority, now and in the future, to assure that we remain on the leading edge regarding quality assurance in our manufacturing operations))

THE FDA INSPECTIONS DON'T SEEM TO BE SLOWING ELI LILLY'S SPENDING.

THE COMPANY JUST BROKE GROUND, THIS WEEK, ON A NEW INSULIN PLANT IN VIRGINIA... A 425-MILLION DOLLAR PROJECT.

AND A NEW RESEARCH AND OFFICE BUILDING WILL BE GOING UP RIGHT HERE IN INDIANAPOLIS, FOR 225-MILLION DOLLARS.

AS FAR AS ELI LILLY'S PIPELINE IS CONCERNED... THERE ARE *TEN* NEW DRUGS WAITING FOR FDA APPROVAL.

THE RELEASE OF CIALIS... THE MALE IMPOTENCY DRUG... WAS PUT ON HOLD, IN PART, BECAUSE OF THE INSPECTIONS-- BUT THE COMPANY IS HOPING IT'LL BE MADE PUBLIC NEXT YEAR. WE'LL KEEP YOU POSTED.

Martha Weaver: AND WHEN WILL THE INSPECTIONS BE DONE?

Kristi Tedesco: THIS CURRENT ROUND COULD BE DONE LATER THIS MONTH... BUT THE COMPANY STILL HAS TO ADDRESS ALL THE ISSUES.

INSPECTIONS ARE HELD *AT LEAST* EVERY THREE YEARS... SO THERE WILL BE INSPECTIONS AS LONG AS ELI LILLY IS IN BUSINESS.


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