Electronic drug registration and listing process was a leading source of complaints last year
This article was originally published in The Gold Sheet
Difficulty complying with a new requirement to register drug manufacturing facilities electronically was one of the 12 main reasons industry complained to the ombudsman in FDA's center for drugs in 2009. Prior to June 1, industry faxed or mailed paper forms to update FDA on which facilities were involved in producing which drugs. Afterward, they had to use a new electronic process ("The Gold Sheet," November 2008). "Many companies, especially small businesses, complained that the 13-step electronic process was too complicated and lengthy," the ombudsman, Virginia Behr, said in her annual report for 2009. One of the top reasons consumers and healthcare professional contacted the ombudsman was to report suspicions of contaminated and adulterated drugs. Behr also reported "far fewer" complaints last year about delays in responding to Freedom of Information Act requests, with the agency reducing its backlog by 12.4 percent.
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What facilities produce what drugs for the U.S. market? FDA is committed to obtaining a more accurate answer to that question by requiring electronic registration and listing - and by knocking on doors if necessary. A registration fee could be coming, if pending legislation is any indication. Although the agency has long sought to improve its flawed paper drug registration and listing process, progress is much quicker with Congress reacting to fears of substandard ingredient suppliers in China. Under the new approach, all registered facilities will have unique numerical identifiers called DUNS numbers obtained from Dun & Bradstreet. Meanwhile, FDA is turning to commercial databases to clean up its list of drugs on the U.S. market - and flush out illegal unapproved drugs for targeted enforcement actions.
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