OTC Medicines

Unlike other drugs subject to user fees, nonprescription drugs under the Monograph system are not subject to FDA approval prior to marketing. Many of these ingredients have been marketed for more than 40 years, with a long history of safe use. We must define value differently than industries subject to FDA approval prior to marketing.

CHPA is pleased to lend its strong support for the DXM Abuse Prevention Act (S. 2994), introduced into the U.S. Senate by Senators Bob Casey Jr. (D-PA) and Lisa Murkowski (R-AK).

CHPA issued the following statement following the Food and Drug Administration’s announcement of a public meeting to gather stakeholder input on the potential development of a user fee program for nonprescription monograph drugs.

CHPA applauds the state of Georgia for becoming the thirty-third state to adopt the real-time, stop-sale technology called the National Precursor Log Exchange (NPLEx).

CHPA, which represents leading manufacturers of OTC cough medicines, strongly supports this legislation and is joined many by substance abuse prevention organizations such as the Community Anti-Drug Coalitions of America and the Partnership for Drug-Free Kids.

CHPA spoke today before a Food and Drug Administration Advisory Nonprescription Drugs Advisory Committee, during which the committee discussed data submitted by Galderma Laboratories, L.P. to support the supplemental new drug application for over-the-counter marketing of adapalene gel 0.1%.

CHPA released the following statement today in support of a Florida law prohibiting the sale of OTC medicines containing the cough suppressant dextromethorphan (DXM) to minors.