Rep. Emerson Introduces Authorized Generic Legislation; New “FDA Legislation Tracker” Feature Added to FDA Law Blog

February 3, 2009

By Kurt R. Karst –      

Representative Jo Ann Emerson (R-MO) has introduced a bill to amend the FDC Act that would prohibit the marketing of authorized generics during a generic applicant’s 180-day exclusivity period.  The bill, H.R. 573, is almost identical to the bill Rep. Emerson introduced during the 110th Congress – H.R. 806.  The Senate version of that bill was introduced by Senator Jay Rockefeller (D-WV) – S. 438, the Fair Prescription Drug Competition Act.  A Senate companion bill to Rep. Emerson’s latest bill has not yet been introduced. 

Interest in authorized generics has steadily increased over the past few years, particularly after FDA denied citizen petitions in 2004, concluding that “[t]he marketing of authorized generics during the 180-day exclusivity period is a long-standing, pro-competitive practice, permissible under the FDC Act,” and legal challenges upheld FDA’s determination.  (See an article we published on the topic in RAPS Focus.)  The Federal Trade Commission (“FTC”) is currently studying the competitive effects of authorized generics.  Some legislative action has already been taken with respect to gathering information on authorized generics.  As we previously reported, the FDA Amendments Act amended the FDC Act to create new § 505(t) – “Database for Authorized Generic Drugs” – that requires FDA to compile and publish a complete list of all authorized generic drugs identified in annual reports submitted to the Agency since January 1, 1999.  FDA has issued a direct final rule, as well as a companion proposed rule, to implement FDAAA § 920.  Among other uses, this list is intended to assist the FTC as the Commission moves ahead with its study.

Pundits have predicted that a large amount of FDA-related legislation will be introduced in the 111th Congress.  To help our loyal FDA Law Blog readers follow these legislative developments, we have decided to create a new tracker feature on the blog – the “FDA Legislation Tracker.”  The legislation tracker, along with our “FDC Act § 505(q) Citizen Petition Tracker,” appear on the right-hand side of FDA Law Blog.  We will update the legislation tracker as new bills are introduced.  To access the text and a summary of legislation identified in the tracker, press and hold the control key on your keyboard and click on the pdf icon.

Categories: Hatch-Waxman