Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 72

In the United States, an over-the-counter (OTC) product is sold based on whether it got to market via (1) an approved New Drug Application (NDA) (Rx to OTC switch) or an Abbreviated New Drug Application (ANDA), or (2) the OTC drug monograph process. The Time and Extent Application (TEA) is another method to get a product onto the market via the monograph process, but this is rarely used.

The safety obligations depend on which method is used to get the product to market. If an OTC product has an approved NDA, the requirements are the same as for a prescription product (expedited reports, periodic reports, etc.). For monograph products, the situation is different. Until 2007, there were no obligatory safety reporting requirements, though many manufacturers voluntarily reported SAEs to the FDA.

The regulations and guidances changed when FDA put forth the following:

Dietary Supplement and Nonprescription Drug Consumer Protection Act, December 2006 https://www.congress.gov/109/plaws/publ462/PLAW-109publ462.pdf and

Guidance for Industry Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application, July 2009 https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm171383.htm

These documents changed the reporting requirements for the monograph products:

A manufacturer, packer, or distributor whose name is on the label (called the “responsible person”) must submit to FDA all SAEs with a copy of the label within 15 business days.

All follow-up information received within 1 year of the initial report must be submitted within 15 business days.

The requirements say 1 year, but FDA wants no time limit. That is, report all follow-ups forever.

Use E2B (MedWatch forms are not accepted from manufacturers, but can be used by consumers and the healthcare community).

Use NDA definitions for minimum criteria, reportability, and so forth.

For brand families need to know the active ingredient to have a reportable drug.

If multiple suspect drugs, submit Individual Case Safety Report (ICSR) to FDA and to other manufacturers.

No aggregate reporting requirements, but FDA has occasionally requested ad hoc compilations or reports to address safety concerns.

Reporting requirements for NDA/ANDA products were unchanged as a result of the changed OTC requirements.