FDA Moves to Expand NDC Numbering to Accommodate Rapid Rise in " Authorized Generic " Drugs

On July 22, 2022, the U.S. Food and Drug Administration ( " FDA " ) announced a proposed new rule (seehttps://www.federalregister.gov/documents/2022/07/25/2022-15414/revising-the-national-drug-code-format-and-drug-label-barcode-requirements for the announcement in theFederal Register, or the FDA ' s own page on the announcement athttps://www.fda.gov/drugs/drug-approvals-and-databases/proposed-rule-revising-national-drug-code-format, effectively Revising the National Drug Code Format and Drug Label Barcode Requirements (Docket No.FDA-2021-N-1351), that is intended to minimize the impact of the FDA running out of ten-digit national drug codes (NDC ' s) by adopting a single, uniform 12-digit format for FDA-assigned NDC ' s. In other words, its expanding the NDC numbering system from 10-digits to 12-digits.    In recent years, because of the manner in which vertically-integrated (with commercial healthcare insurance companies) Pharmacy Benefit Managers ( " PBM ' s " ) aggregate Rx rebate dollars (forcing drug list prices to INCREASE as a result), FDA has seen many drug manufacturers respond by introducing so-called " authorized generic " products (the FDA defines an "authorized generic" as exactly the same product as an approved branded drug, but is marketed without the brand-name on the label) in an effort to try and bypass the impact of PBM rebating which puts upward pressure on drug list prices, and make the " authorized generic " drug products more afforda...
Source: Scott's Web Log - Category: Endocrinology Tags: authorized generic 2022 authorized generics FDA insulin NDC Source Type: blogs