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FDAAA: Drug Safety Throughout The Lifecycle

Mar 27, 2014
FDAAA: Drug Safety throughout the Lifecycle

The FDA Amendment Act (FDAAA) places an emphasis on “safety throughout the lifecycle,” namely close monitoring throughout the product lifecycle: before marketing and after licensure.

In the past six months, the FDA has taken a series of actions to regulate drugs imported to the U.S. In September of 2013, the FDA blocked imports of medicine made in the Ranbaxy Plant of India. According to the U.S. Food and Drug Administration, the import alert resulted from Ranbaxy’s constant and significant violations of manufacturing rules. Ranbaxy would not be allowed to manufacture drugs for the U.S at the Mohali site where the plant inspectors uncovered manufacturing violations until a third party inspector is hired to help it meet the FDA compliances.

According to the FDA Commissioner, Margaret Hamburg, multiple U.S. import suspensions on Indian pharmaceutical companies are part of a global effort to improve drug safety. This FDA amendment calls for further global collaborations; enhancing drug safety is not a domestic issue. In her presentation for 2010 FDA Vaccine Safety Webinar, Dr. Sutherland suggested that the FDA partner with World Health Organization (WHO) and other NGOs to construct an efficient global regulatory system. This also requires efficient information sharing arrangements between various drug regulatory authorities.



As the U.S. consumes larger amounts of imported medicines each year, the FDA implemented more efforts on surveillance over drug production worldwide. In the future, the U.S. FDA may increase staff inspectors abroad to supervise manufacture sites that export drugs to the U.S. India is the U.S.’s second largest medication supplier, and Ranbaxy, the biggest drug producer in India, has been hit by a series of FDA import suspensions since 2008. Indian Health Services (IHS) is listed as a major federal partner in improving biologic product safety and future collaboration is expected from both sides.

Meanwhile, some leading pharmaceutical companies abroad receive expedited U.S. entry through a pilot program that puts the “trustworthy foreign-made medicines” on the fast tracks into the U.S. This pilot program included 13 pharmaceutical titans, including Pfizer Inc. and GlaxoSmithKline LLC, due to their satisfactory corrective plans to rectify the most potential problems as well as their ability to “control their drugs from the time of manufacture abroad until the point of importation into the U.S.”

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References:

Dan Prochilo, “Pfizer, GSK To Have Imported Drugs Fast-Tracked By FDA”. http://www.law360.com/articles/510906/pfizer-gsk-to-have-imported-drugs-fast-tracked-by-fda

Andrea Sutherland, “Beyond VAERS: How the FDA continues to improve vaccine safety surveillance”. http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/UCM218707.pdf

“FDA chief: U.S. is ‘not targeting’ India with new drug import rules”. http://www.rawstory.com/rs/2014/02/21/fda-chief-u-s-is-not-targeting-india-with-new-drug-import-rules/



Written by:

Ivory Wu, Sharp Semantic Scribe

Traveling from Beijing to Massachusetts, Ivory recently graduated with a BA from Wellesley College in Sociology and Economics. Scholastic Ivory has also studied at NYU Stern School of Business as well as MIT. She joins Temperature@lert as the Sharp Semantic Scribe, where she creates weekly blog posts and assists with marketing team projects. When Ivory is not working on her posts and her studies, she enjoys cooking and eating sweets, traveling and couch surfing (12 countries and counting), and fencing (She was the Women's Foil Champion in Beijing at 15!). For this active blogger, Ivory's favorite temperature is 72°F because it's the perfect temperature for outdoor jogging.

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