GPhA says proposed new legislation in US will close authorized generic loophole

The USA's Generic Pharmaceutical Association (GPhA) has praised legislation introduced by Senators John Rockefeller IV (Democrat-West Virginia), Charles Schumer (D-New York) and Patrick Leahy (D-Vermont) that would amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generics during the 180-day exclusivity period of drug patent challengers.

The GPhA said the measure will close another loophole that needlessly delays generic entry into the market. This tactic, it maintains, has been utilized extensively by the brand pharmaceutical industry over the past three years and has upset the balance of the Hatch-Waxman Act by discouraging investment in generic patent challenges that have previously delivered billions of dollars in savings to American consumers (Marketlettter July 10).

"Special interests will try to defeat the bill"