FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Reference Drug List Flags Companies That Hinder Generics

May 21, 2018

In an effort to curb the “gaming tactics” that delay generic drug competition, the FDA released a public list of companies found to be potentially restricting access to samples of their branded products.

In a statement accompanying the release of the list, FDA Commissioner Scott Gottlieb noted some brand companies use tactics to forestall expected generic entry such as making it difficult for generic companies to purchase their products, which are essential for developing generic alternatives to branded drugs.

Some drugmakers refuse to sell samples of products using REMS with Elements to Assure Safe Use (ETASU), affecting distribution to generic competitors, or set conditions for sales that generics companies cannot meet.

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