Senators Introduce Bill to Ban Authorized Generics During 180 Day Exclusivity Periods

Senators Jay Rockefeller (D-WV), Patrick Leahy (D-VT), and Charles Schumer (D-NY) introduced a bill, S. 3695, last Thursday that would ban the sale of authorized generic drugs during the first ANDA filer's 180 day exclusivity period.  The bill was introduced just hours after the Senate Special Committee on Aging held a hearing entitled "The Generic Drug Maze: Speeding Access to Affordable Life-Saving Drugs."  Authorized generics were a hot topic at the hearing.

Also last Thursday, Sen. Rockefeller issued a press release in which he lauded the efforts of Mylan Laboratories, based in his home state of West Virginia, for its efforts toward fighting authorized generics.  In the release, Sen. Rockefeller states that Hatch-Waxman grants the first ANDA filer "180 days of exclusive market rights, which is just a fraction of the up to 20 years of exclusive market rights given to brand companies."  Sen. Rockefeller doesn't mention that brand companies, in contrast to generic drug makers, obtain their market exclusivity through patents on their inventions.

The D.C. Circuit and, more recently, the Fourth Circuit have both upheld the legality of authorized generics.  Therefore, legislation will be necessary if generic drug makers hope to end the practice.

RELATED READING:

• 21 July 06 Reuters article on the bill
• 21 July 06 Los Angeles Times article on the bill
• 20 July 06 press release from Sen. Leahy's office
• 20 July 06 press release from Sen. Rockefeller's office