First Year Of Mandatory Reports Shows Safety-Monitoring Value Of AER Data
This article was originally published in The Tan Sheet
Executive Summary
The spike in dietary supplement adverse event reports in 2008 demonstrates that mandatory reporting gives FDA a more effective safety surveillance tool than voluntary reporting alone
|
The spike in dietary supplement adverse event reports in 2008 demonstrates that mandatory reporting gives FDA a more effective safety surveillance tool than voluntary reporting alone. Post-market surveillance "is about the only way in which FDA can monitor the safety of dietary supplements," said Bill Frankos, director of FDA's Division of Dietary Supplement Programs. There is no pre-market review for supplements except for new dietary ingredient applications, which Frankos said are not commonly submitted. He estimated FDA receives about 100 NDIs annually, a "small fraction" of the more than 30,000 products on the market. Frankos discussed the first year of supplement AER data at the Consumer Healthcare Products Association's Regulatory and Scientific Conference May 7 in National Harbor, Md. AERs for supplements and OTC drugs became mandatory in January 2008 (1 (Also see "FDA Audits Of Supplement, OTC AERs Likely Starting This Year – Consultant" - Pink Sheet, 21 Jul, 2008.), p. 3). "Post-market surveillance is very hard, especially when you have so few reports. So, the most we can do is look for signals and then when we get a signal we can look more carefully at the ingredients, at the literature," Frankos said. For example, voluntary AER data led FDA to request a recall of Iovate Health Sciences' Hydroxycut weight-loss products after finding a possible link to liver injury (2 (Also see "Hydroxycut Recall Sheds Light On Pros And Cons Of AER System" - Pink Sheet, 4 May, 2009.), p. 7). Ostensibly, mandatory reporting will improve FDA's ability to identify signals by providing the agency with more data. FDA received 1,080 AERs in 2008 - 672 mandatory, 418 voluntary and 10 duplicates - compared to 317 voluntary AERs in 2006 and 350 in 2007 (see chart previous page). The reason for the increase is clear, said Daniel Fabricant, VP of scientific and regulatory affairs for the Natural Product Association. "The uptick is just the rule being put into play," he said in an interview. "There was a slight uptick in the voluntary reports, but it wasn't much." The majority of adverse event reports are for "unconventional" vitamin/mineral/protein combinations, which account for 67.4 percent of mandatory reports and 85.5 of voluntary reports, according to FDA data. Higher sales may account for the greater proportion of adverse events in categories that include vitamins, Frankos explained. He pointed out "big pharma-type companies," which have more market share, submit most of the AERs. Roughly 50 firms submitted AERs, which account for a small part of the supplement industry, said Michael McGuffin, president of the American Herbal Products Association at the SupplySide East tradeshow April 29 in Secaucus, N.J. However, he said the low proportion of firms reporting AEs does not necessarily mean they failed to report adverse events, because not all firms have serious adverse events. McGuffin said the industry produces "a safe class of goods" and the low number of AERs is not surprising. He noted some firms may over-report AEs by submitting reports for consumer complaints that do not qualify as serious adverse events. On the other hand, some firms "certainly" under-report AERs, he said. "A variety of sources" at FDA have noted their concern about under-reported AERs, said Rick Kingston, president of scientific and regulatory affairs for Safety Call International. "FDA is concerned about under-reporting across the board as the current pool of AEs that they have received come from less than 50 companies and there are more than a thousand companies in this market space," Kingston said in an e-mail. FDA also is concerned about other challenges the data pose, including distinguishing between AEs related to adulteration and pharmacological effects, Frankos said. Further, the agency is "worried about poly-supplementation," such as when consumers complain "about one supplement, but [are] taking five others," he added. Frankos noted FDA is improving data-mining for supplement AERs. - Katie Stevenson ([email protected]) and Elizabeth Crawford ([email protected]) |