CHPA Favors Alternate Plan For CPSC Database Covering OTCs, Supplements
This article was originally published in The Tan Sheet
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The Consumer Healthcare Products Association says an alternate proposal for implementing the Consumer Product Safety Information Database will ensure information published from consumer complaints is accurate and verifiable. The Consumer Product Safety Commission's database, mandated by 2008 legislation and slated for implementation by March 2011, will be a clearinghouse for adverse event reports linked to consumer products, including OTC drugs and dietary supplements. In a Nov. 16 letter to the commission, CHPA recommends CPSC adopt provisions of a database proposal offered Nov. 9 by Commissioners Anne Northup and Nancy Nord. Northup and Nord's proposal is an alternative to the initial implementation plan supported by the three other commissioners, including Chairman Inez Tenenbaum. It tracks the proposed rule CPSC staff published in May.
CHPA says it supports the alternate proposal in part because it allows CPSC to ensure an incident report's accuracy before publishing it to the public database. In contrast, the initial proposal requires that CPSC publish a report, verified or not, within 10 days of sending it to the manufacturer. CHPA also favors Northup and Nord's language to allow firms to verify that reports are not duplicative. Further, the trade group supports a provision that tightens the definition of who may submit legitimate reports of harm. The provision requires parties submitting information to the database – whether it is a consumer with a complaint or a third-party representative – to "directly obtain verifiable information" about the incident reported. Finally, CHPA backs a provision that requires the sources of complaints to provide more information on incidents, such as the identity of the harmed consumer and incident location. Commissioners Split Over Database Plan CPSC's commissioners will discuss the proposals and vote on the database implementation at a Nov. 24 meeting. The minutes of an April 15 commissioners' meeting indicate Northup and Nord have their work cut out for them to convince another commissioner to vote for their plan – most of the pair's amendments to the proposed rule failed at that meeting. The proposed rule the majority of commissioners support "suffers from admitting too many unreliable reports with far too few details into the public database," Northup said in an April 22 statement. "This scattershot approach to data collection will generate a database of dubious reliability. As a result, the database will become useless at best – and potentially far more destructive than that," she added. OTCs, Supplements Fail To Escape CPSC Despite its support for the alternate implementation proposal, CHPA reiterates to CPSC its position that "OTC and dietary supplement product incident reports should not be included in the database" ("CHPA says keep drug, supplement AERs out of CPSC database," "The Tan Sheet" July 26, 2010, In Brief). Although OTCs and supplements are regulated by FDA – which requires the products' manufacturers to submit serious AERs – their packaging is covered by the Poison Prevention Packaging Act, administered by CPSC. The commission declined to exempt OTCs and supplements from certifying child-resistant closures under the Consumer Product Safety Improvements Act of 2008 (Also see "Package Certification Law Bears Down On Vitamins As Trade Groups Scramble" - Pink Sheet, 10 Nov, 2008.). Toxicology consultant Rick Kingston said in an interview that provisions of the proposed database rule could pose logistical issues for CPSC, and make public more and potentially inaccurate AER information. "I don't know how [CPSC] would be able to transmit the information to the manufacturer, have a 10-day turnaround, be able to evaluate that data, and then have it published and expect that it's going to be accurate without flaws," said Kingston, president of regulatory and scientific affairs with SafetyCall International. He added, whether CPSC will keep a tight lid on the information verification and publication process, or whether incident reports will quickly find their way into the public domain, remains unresolved. In July, Kingston advised firms to bolster their AER collection systems and product labeling if they want consumers to submit incident reports to them rather than CPSC ( (Also see "IFT Annual Meeting & Food Expo In Brief" - Pink Sheet, 2 Aug, 2010.), IFT Annual Meeting & Food Expo In Brief). However, industry will have to contend with CPSC's significant public awareness campaign surrounding the launch of its database at www.SaferProducts.gov. By Dan Schiff |