Regulatory Focus™ > News Articles > Woodcock Calls for Prescription Drug Tracking System

Woodcock Calls for Prescription Drug Tracking System

Posted 09 March 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is calling for a prescription drug tracking system to ensure the pharmaceutical supply chain's integrity, reports The Financial Times.

Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, testified before the House Energy and Commerce Committee on 8 March and called for Congress to grant FDA additional authority to secure the supply chain.

"Currently there is no complete record of all parties who have been involved with the distribution of a product after it leaves the manufacturer until it reaches the hands of the patient," said Woodcock. "This leaves multiple opportunities for counterfeit, adulterated, stolen or otherwise violative products to be introduced into the supply chain."

"It's become a Wild West and it's putting patients in harm's way," continued Woodcock.

Woodcock further noted that the goal was to prevent counterfeit drugs from ever entering the supply chain, and said the current regulatory system was inadequate to deal with counterfeiting pressures.

One sticking point of the program might be the costs associated with the development and upkeep of an anti-counterfeit system. Woodcock sought to assuage critics by saying that the costs were preferable to a "mass poisoning" of the public by counterfeit products.

Read more:

Financial Times - FDA calls for drug tracking system

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