FDA Forges Stronger Connections Abroad

FDA is not yet formally a member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S), but applied for membership last year, FDA News reports. The Agency's chief medical officer Janet Woodcock has reaffirmed FDA's  plans to increase communication with foreign inspection authorities after it is accepted into PIC/S.  "The antithesis of quality is having to do your production seven different ways because seven different regulators have little changes that they wanted you to make," Woodcock said at the recent Parenteral Drug Association's Quality by Design for Biopharmaceuticals conference. PIC/S is a forum in which regulatory bodies can exchange information and experience in GMP-related areas, and its membership includes various European health authorities, Australia and Canada. "We've got international harmonization problems in the pharmaceutical quality area, and you recognize that many countries such as Brazil and India "¦ they're in line to become players now," Woodcock said. FDA will need all the help it can get, both in inspecting foreign imports as well as manufacturing facilities outside the U.S. In a June interview with Robert Cohen of Newhouse News, Woodcock reportedly said that the agency was equipped to inspect less than 1 percent of all products imported into the U.S.. "There has been an explosion of imports," Woodcock said in an interview. "The world has globalized and all this stuff is coming in from outside the United States, but the regulations and procedures we have in place really did not contemplate this change." "Our ability to inspect all the production facilities outside the United States or monitor clinical trials or the manufacture of medical products is very limited," she said. "Are we concerned? Yes, we are concerned about this. We see this trend increasing." The FDA said it will inspect only 0.7 percent of the estimated 16.3 million shipments it regulates that will come across the borders and into American ports this year from more than 230 countries. "Given that they look at only a small fraction of what is coming in, you have to assume a lot gets through," said Michael Taylor, a former FDA deputy commissioner and now professor at University of Maryland School of Medicine. In 2006, the FDA blocked 77,260 of 14.9 million shipments for health and safety reasons, up from 54,577 in 2005. The FDA also is only able to check up on a very small number of the 300,000 foreign manufacturers that make FDA-regulated products shipped to the United States. In 2006, the FDA reported it inspected about 500 foreign drug manufacturing plants out of more than 2,700. This included 202 companies that were seeking drug approvals, 164 plants for manufacturing quality, 124 doing biomedical research and 10 to follow up an adverse drug reactions. As the June article noted, four out of 10 prescription drugs sole in the U.S. are manufactured abroad, and 80 percent of the active pharmaceutical ingredients used by U.S. manufacturers to make prescription drugs are imported. Dr. Woodcock touches on PIC/S briefly in this audio interview, done shortly after she was named CMO. Click here to download. -AMS

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  • <p>That is great news. I pity the animals that are being made into test dummies. They too have the same life we enjoy and making them suffer for the sake of science is not fair. - <a href="http://presentationsolutions.org/2011/10/25/advice-from-dr-naveed-fazlani">Dr. Naveed Fazlani</a> </p>


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