Legislation to ban authorized generics during 180-day exclusivity makes a comeback in Congress

Last week, substantively identical legislation was introduced in both the US House of Representatives and in the Senate to amend the FDC Act to prohibit the manufacture, marketing, sale or distribution of an authorized generic version of a New Drug Application-approved drug until any period of 180-day exclusivity associated with an Abbreviated NDA for a generic version of that NDA-approved drug has expired or has been forfeited, explains Kurt Karst of law firm Hyman, Phelps & McNamara.

The Senate version of the bill, S 373, is titled the “Fair Prescription Drug Competition Act.” The bill was introduced by Senator John Rockefeller (Democrat, West Virginia), and is co-sponsored by Senators Daniel Inouye (Dem, Hawaii), Patrick Leahy (Dem, Vermont), Charles Schumer (Dem, New York), Jeanne Shaheen (Dem, New Hampshire), and Debbie Stabenow (Dem, Michigan). The House version of the bill, HR 741, was introduced by Representative Jo Ann Emerson (Republican, Missouri). The bills introduced in the 112th Congress to ban authorized generics during the pendency of 180-day exclusivity are the latest iterations of legislation that dates back to at least the 110th Congress, when Rep Emerson and Sen Rockefeller introduced HR 806 and S 438, respectively.

Both S 373 and HR 741 would amend FDC Act section 505 to add new subsection (w) - “Prohibition of Authorized Generic Drugs” – to state: