By Kurt R. Karst –
The Federal Trade Commission (“FTC”) announced the publication of an interim report on authorized generic drugs. The report, titled “Authorized Generics: An Interim Report,” presents the first set of results from an FTC study conducted, at the request of several members of Congress, to examine the short-term and long-term effects of authorized generics on competition in the prescription drug marketplace. The report has been in the making for some years. In March 2006, the FTC proposed a study of the competitive effects of authorized generics. In April 2007, the FTC announced that it was seeking public comment on its proposed information requests to firms in the prescription drug industry. In December 2007, the FTC announced the issuance of those information requests.
Below are the results of the FTC’s preliminary data analysis on the short-term effects of authorized generics on competition during 180-day exclusivity. According to the FTC:
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 FDA Amendments Act ("FDAAA") 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. Among other uses, this list is intended to assist the FTC as the Commission progresses with its authorized generics study. In September 2008, FDA issued a direct final rule and a companion proposed rule to implement FDAAA § 920. FDA withdrew the direct final rule after the Agency received “significant adverse comment.” Congress is also considering legislation concerning authorized generics. Earlier this year, Rep. Jo Ann Emerson (R-MO) introduced H.R. 573, which would amend the FDC Act to prohibit the marketing of authorized generics during a generic applicant’s 180-day exclusivity period. The bill is almost identical to the bill Rep. Emerson introduced during the 110th Congress - H.R. 806. Senator Jay Rockefeller (D-WV) has introduced a similar bill in the U.S. Senate - S. 501.