Exclusive 5 On Your Side investigation uncovers serious quality concerns at northeast Ohio drug lab

Pharmaceutical lab contributing to drug shortages

Bedford - An exclusive 5 On Your Side investigation uncovers government documents citing "quality control" issues at a northeast Ohio pharmaceutical lab.

Inspectors with the U.S. Food and Drug Administration spent nearly two weeks reviewing procedures at Ben Venue Laboratories in Bedford last May.

The 33-page report obtained by NewsChannel5 revealed that inspectors found "quality control" problems that included "lack of adequate oversight, stainless steel particles in some drugs, gloves not sterilized and bacterial contamination."

Ben Venue labs declined an interview but released a statement that read, "since the inspection... we have made a number of changes."

The company also conceded that "manufacturing and quality disruptions" have contributed to drug shortages.

In Washington, Capt. Valerie Jensen, associate director of the FDA's Drug Shortage Program, said inspections at labs across the country have found quality control issues.

" When we look back at the reasons for these shortages", said Jensen, "the large number of them have been because of quality issues at the manufacturers."

Jensen also said the shortages largely involve older, injectable drugs that often are discontinued.

"Unfortunately," said Jensen, "they are less profitable than newer drugs."

Nikki Pettrey and Richard Burdette are both fighting cancer and rely on drug made by other companies.

Both were told the drugs used in their treatments may not be available, but were fortunate that other drugs became available for them.

Even so, both Pettrey and Burdette said the FDA's finding that profits could play a role in life saving drug shortages is stunning.

"Unfortunately, cancer is big business," said Burdette, "and I think it comes down to big business."

The national drug shortage has prompted legislation by Sen. Sherrod Brown (D-Ohio) that would require pharmaceutical companies to alert hospital and physicians of pending drug shortages.

"At least the drug companies need to tell the government and we then can tell patients there is an impending shortage," said Brown.

Just last month, President Obama issued an executive order urging the FDA to push drug companies harder to reveal when vital drugs will be in short supply.

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