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Second, CHPA stated that even if the agency’s interpretation of an address requirement is correct, a draft guidance is an inappropriate means to announce a binding conclusion.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.
Abkit rolls out new flavors of Zucol Coldcare
DESTIN, Fla. Abkit, which launched its two Zucol Coldcare exclusively in Rite Aid earlier this year, showcased its menthol- and orange creme-flavored homeopathic SKUs to buyers at the ECRM Cough & Cold and Allergy here this past week. The same formula marketed by parent company Schwabe is the No. 1 OTC brand in Germany, under the Umckaloabo brand name, where it generates $230.7 million in annual sales, Abkit executives reported.
The homeopathic ingredients in Zucol are supported by some 19 clinical trials which included results from almost 3,000 patients.
Zyrtec-D added to Perrigo’s private label
ALLEGAN, Mich. Perrigo on Thursday added Zyrtec-D to its private label offerings, following final Food and Drug Administration approval of Teva Pharmaceutical’s abbreviated new drug application for an over-the-counter version of cetirizine hydrochloride, pseudoephedrine hydrochloride extended-release tablets, 5 mg/120 mg.
According to Wolters Kluwer data, brand sales for the original prescription strength version of the product for the 12 months ending December 2007 were approximately $190 million.
“This approval and marketing agreement reflect our strategy to be first to market with the important products that make quality healthcare more affordable for our customers and drive value for our shareholders,” stated Perrigo’s chairman and chief executive officer Joseph Papa.
Perrigo expects to begin shipping the product in the next 90 days.