Pharmakon Labs Shut Down

Well, it didn't take long for FDA's new Commissioner to take action. Just days after being confirmed by the Senate, Lester Crawford speaks out. "This action by Judge Lazzara sends a strong signal that FDA will take action against drugs that fail to meet quality standards," stated FDA Commissioner Lester M. Crawford. "As the nation's top enforcer of manufacturing standards, the FDA will continue to ensure that drugs being sold in this country meet those crucial requirements."

On July 26, FDA obtained a permanent injunction against Pharmakon Laboratories, forcing the company to shut down operations. The company manufactures and distributes cough and cold liquids, tablets, and caplets.

Following inspections by FDA and a trial in US District Court, Judge Richard A. Lazzara found that drug products sold by Pharmakon did not meet current good manufacturing practice standards and other legal requirements.

This isn't the first time Pharmakon's manufacturing practices have been questioned. In September 2001, the company received a warning letter citing failure to label proper dosage; failure to establish qualification for manufacturing equipment ancillary systems; failure to validate or establish written procedures for the validation of equipment operations, water quality, or computer software used to calculate batch formulations, and failure to periodically monitor the quality of water used for manufacturing and cleaning.

The defendants were ordered by the Court to halt manufacturing and distributing drugs until they meet FDA’s CGMP standards and receive marketing approvals.

Training Tip

The above example provides a terrific lesson you can use in your GMP training process.

Print a copy of FDA's Press Release and distribute it to your GMP training participants. (You can download a copy here - http://www.gmptrainingsystems.com/asp/articles.asp )

Ask people to examine the reasons stated for the court action. Failure to validate, Failure to establish written procedures, Failure to monitor the quality of water, a key raw material. These are all basic GMP issues and can be addressed.

Ask participants to estimate the cost of implementing fixes for the above. Then ask them to estimate the cost of the shut down. Which do you suppose is cheaper?

Now that this company has been ordered to shut down operations, what becomes of their customers? They will all have to find other suppliers. If and when this company implements fixes and gets FDA's approval to start back up, do you think their customers will stampede back to their doorstep?

This example clearly demonstrates the power FDA has and the willingness of the new Commissioner to use it.

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We design and conduct GMP Training Programs for the Pharmaceutical and Medical Device industries. Our clients include Pfizer, Bristol-Myers Squibb, Baxa Corp., Genentech, Wyeth, Glaxo SmithKline, Grifols Biologicals, and several others.