CHPA says keep drug, supplement AERs out ot CPSC database
This article was originally published in The Tan Sheet
Executive Summary
The Consumer Healthcare Products Association argues OTC drug and dietary supplement adverse event reports should not be part of a safety incident database required by the Consumer Product Safety Improvement Act of 2008. In a July 20 letter to the Consumer Product Safety Commission, CHPA Associate General Counsel Alison Manhoff says the act exempts the type of food and drug products manufactured by CHPA members because they already are regulated by FDA. CPSC has regulatory authority over only food and drug products with packaging requirements covered in the Poison Prevention Packaging Act, Manhoff writes. Additionally, CHPA worries that consumers will be confused about where to report adverse events if PPPA products are included in CPSC's database. She explains that consumers may report incidents related to a drug or supplement to CPSC instead of FDA, thus delaying the possibility of a safety review. Manhoff writes "it is imperative that the commission provide sufficient instructions making it clear to the consumer that reports regarding the drug or dietary supplement itself should not be submitted to CPSC and must be reported directly to FDA and/or the manufacturer, as appropriate.
You may also be interested in...
CHPA Favors Alternate Plan For CPSC Database Covering OTCs, Supplements
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.
US FDA Drugs Center Ready To Break Down Silos On Regulatory Innovation
CDER Director Cavazzoni is promising to increase coordination and collaboration to accelerate broader adoption of innovative clinical trial designs and other approaches to speed drug development. A new "Quantitative Medicine Center of Excellence" illustrates the approach.
New OSP Director To Guide CDER-Wide IT Upgrades; System Enhancements Speed ANDA Assessments
Generic Drug Structured Assessment for Bioequivalence launched in 2023 and has been used in 40 ANDA reviews so far.