FDA to Outsource Inspections of Non-U.S. Pharmaceutical Factories
With the advent of globalization and the move of manufacturing plants off shore, many drug manufacturers have taken advantage of lower costs and shipped American jobs overseas. Unfortunately the FDA’s U.S. based inspectors did not follow overseas to ensure the quality of the products manufacture for consumption in the U.S.
In the U.S., FDA inspections generally occur every 30 months according to the Government Accountability Office. But how often do the seam inspections occur in the off shored locations? About once every nine years.
In an article in Bloomberg news, the FDA’s acting principal deputy commissioner, John Taylor (a former executive at Abbot Labs and Biotechnology Industry Trade Organization in Washington) said the agency is looking to outsource the inspections to private concerns. Click here to read the article about the FDA Outsourcing Overseas Factory Inspections.
Drugmakers have farmed out everything from research and manufacturing to IT and sales. In January 2010 Eli Lilly said it would outsource more of its R&D, and in December 2009 AstraZeneca announced more outsourced manufacturing. Click here to read more about Pharmaceutical Company Outsourcing.
To read a previous Brandi Law Firm Blog entry regarding what could go wrong at foreign pharmaceutical factories, click here: Drug Manufacturer Whistle-Blower Exposes Facility Failures
With the combined outsourcing of production AND regulation of that production, it seems that the only person that loses is the consumer.
Click her to read more about the Brandi Law Firm lawsuits concerning Avandia, Fosamax, and Yaz.