CHPA objects to FDA adverse event guidances

WASHINGTON The Consumer Healthcare Products Association submitted comments earlier this week that called for the withdrawal of the Food and Drug Administration’s companion draft guidances concerning adverse event report labeling for over-the-counter medicines marketed without approved applications and for dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act, the association announced Friday through its online newsletter.

The draft documents, issued in the Jan. 2 Federal Register, “purport to require inclusion of either a full U.S. mailing address or a phone number on non-new drug application OTC medicine and dietary supplement labels,” CHPA stated. The guidances also recommend that labels include language that drew attention to the address for purposes of reporting adverse events, as opposed to simply providing the contact information and affording the consumer to call with any questions or complements.

The association stated it does not agree with the agency’s conclusion that the underlying statute requires a full mailing address, arguing that there is nothing in the new law that requires manufacturers to deviate from the traditional approach of using city, state and zip code.

Second, CHPA stated that even if the agency’s interpretation of an address requirement is correct, a draft guidance is an inappropriate means to announce a binding conclusion. The association said that the agency should instead use the notice and comment rulemaking process to establish new, enforceable responsibilities.

Finally, CHPA said that it believes the agency’s recommendation that the label should include prefatory language to draw attention to the address solely for purposes of reporting adverse events is misguided. The association pointed out that label contact information is there for consumers to use for any comment or question. Furthermore, the vast majority of consumer contacts have nothing to do with complaints, with possible adverse events comprising an even smaller subset of complaint contacts.

Under the drafts, FDA stated it would exercise enforcement discretion to allow re-labeling until Jan. 2, 2009.

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