Qui Tam

Whistleblowers Needed to Expose Drug Manufacturing Deficiencies

By Nolan and Auerbach

Recently, we discussed GlaxoSmithKline?s False Claims Act settlement, in which the drug maker shelled out $750 million to quiet allegations about manufacturing deficiencies at its Puerto Rico. Based on a recently released FDA inspection report, it looks like another drug company?s Puerto Rican plant is having trouble following current Good Manufacturing Practices (cGMP).

In this report, the FDA rattles off a laundry list of violations at the plant owned by McNeil Consumer Healthcare, a unit of Johnson & Johnson: distribution of drugs that failed quality requirements, a failure to identify product defects during routine testing, failure to detect incorrect expiration dates on drug labels, failure to adequately investigate product problems, failure to follow laboratory controls and inadequate training of lab staff.

Some of these mirror concerns raised in a January 2010 FDA warning letter that was sent McNeil about this same Puerto Rico plant.  McNeil has also seen this scenario play out before at a different plant.  After quality controls failed at its Fort Washington, Pa. plant, the company temporarily closed the plant and recalled an estimated 136 million bottles of liquid children?s Tylenol and other pediatric products.

This latest brush up with the FDA stems from inspections that date from late September through early November. The 10-page report concluded that there was no assurance at the Puerto Rico plant ?that the current laboratory controls are adequate to assure that drug products conform to appropriate standards of identity, strength, quality and purity.? The report also states, ?The established procedures and controls for cleaning and maintenance may not be sufficient to prevent mix-ups and/or contamination during the manufacturing and packaging process as evidenced by the mix-up deviations and incidents involving manufacturing and packaging operations.?

Somebody had the courage to blow the whistle on GlaxoSmithKline?s manufacturing deficiencies. Hopefully a brave McNeil employee can similarly provide the inside information the government needs to further shine a light on the problems at this wayward Puerto Rico facility.

For more information about qui tam law and pharmaceutical fraud, contact Nolan and Auerbach, PA.

Full post as published by Pharma 101 - Pharmaceutical Fraud on December 21, 2010 (boomark / email).