In a recent post from the FDA Voice Blog, Office of Compliance Director for FDA's Center for Drug Evaluation and Research (CDER) wrote about the agency's future activities to help combat the globalized supply chain—in particular about the Food and Drug Administration Safety and Innovation Act (FDASIA).
In addition to sharing his priorities about resolving problems regarding drug compounding, Office of Compliance Director Howard Sklamberg noted that one of his main priorities is the globalized supply chain. He noted how today, "nearly 40 percent of the drugs Americans take are imported and nearly 80 percent of the active ingredients come from overseas sources." He also recognized that a "growing number of clinical trials that test the safety and effectiveness of potential new drugs are also moving overseas, making FDA oversight more challenging."
He also identified that "counterfeit drugs are proliferating around the world and sometimes even entering the U.S. supply chain" and the "ever burgeoning worldwide use of the Internet continues to spawn avenues for illegal online sales of medicines of unknown safety and quality."
Confirming other priorities of the U.S. Department of Justice and recent FDA activities, Sklamberg also noted that "poor manufacturing practices that lead to facility shut-downs often contribute to shortages of important drugs," and another agency priority will be to "ensure that wherever drugs are made, wherever their ingredients are from, or wherever and however they are tested and sold, that they meet FDA's strict standards of quality and that they remain in adequate supply."
- See more at: http://www.policymed.com/2013/07/fda-soliciting-input-on-global-supply-chain-provisions-in-fdasia.html#sthash.qri27XjK.dpuf
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