July 2005 - Pharmaceutical Technology

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PharmTech Europe

July 2005

Pharmaceutical Technology


Recalls, Resignations, and Manufacturing Suspensions Plague Able Labs

Able Laboratories, Inc. (Cranbury, NJ, http://www.ablelabs.com/) announced in late May that it would halt all production and recall all available product because of problematic testing procedures discovered during an internal investigation. The company manufactures mostly generic prescription drugs, including drugs containing acetaminophen.

Chairman and Chief Executive Dhananjay G. Wadekar announced his resignation shortly after the review, as company shares fell nearly 75%. Robert G. Mauro, Able's president and chief operating officer, assumed the role of interim CEO.

According to a release from Able, the company also intends to withdraw seven of its approved abbreviated new drug applications (ANDAs). The company cited various reasons for the withdrawal, including commercial considerations and the identification of unreliable data included in the filings.

On May 27, the US Food and Drug Administration (Rockville, MD, http://www.fda.org/) followed up on the May 25 recall of Able Laboratory's products with a special warning to consumers. FDA said its action is intended to ensure that the public is fully aware that Able is conducting a nationwide recall of all its manufactured drugs because of serious concerns that they were not produced according to quality assurance standards.

The company said on May 27 that it had laid off approximately 200 manufacturing and other employees. On June 9, Able announced plans to reduce its workforce even further to conserve assets.

George Koroneos


RFID Pedigree Program Enters Pilot Phase

In an effort to exert tighter control over the flow of drugs through the supply chain, Purdue Pharma (Stamford, CT, http://www.pharma.com/) and the drug wholesaler H.D. Smith (Springfield, IL, http://www.hdsmith.com/) are implementing a pilot program that uses radio frequency identification (RFID) tags to verify drug authenticity.

The pilot incorporates a SupplyScape (Cambridge, MA, http://www.supplyscape.com/) and Unisys (Blue Bell, PA, http://www.unisys.com/) solution that tracks the distribution of the analgesic product, "Oxycontin," from Purdue's manufacturing facility to the wholesaler. By using RFID electronic barcodes, also known as smart tags, to record the path of the drug in transit, the system is designed to detect whether counterfeit drugs are being introduced into the supply chain. At any point in the supply chain, a tagged drug can be scanned to determine its origin and authenticity.

"Pharmaceutical companies are looking to institute standards that safeguard consumers from the growing threat of counterfeit drugs," said Todd Skrinar, partner, Healthcare and Life Sciences, Unisys in a company statement. "The implementation of an electronic pedigree system can help Purdue increase consumer safety."

This pilot is another phase of Purdue's anticounterfeiting and diversion plan launched in November 2004. The company has already shipped products incorporating RFID tags on individual labels to Wal-Mart and H.D. Smith and expects the new test to help lead to national adoption of pedigree systems for all drugs. The state of Florida has taken a lead in this effort by enacting rules requiring electronic drug pedigrees before July 2006.

George Koroneos


C&M Oxyfill

On May 26, the US Food and Drug Administration (New Orleans, LA, http://www.fda.org/) sent a warning letter to C&M Oxyfill (Wiggins, MS) concerning violations of current good manufacturing practice (CGMP) regulations at the company's compressed oxygen manufacturing facility.


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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
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