Legislation to prohibit companies from marketing an authorized generic version of a Rx drug until after expiration or forfeiture of any 180-day marketing exclusivity associated with an ANDA for a generic version of the drug has been introduced in the House and Senate.
The Fair Prescription Drug Competition Act was introduced by Sen. Jay Rockefeller (D-WV) with five Democrat co-sponsors. The substantively identical House version was introduced by Rep. Jo Ann Anderson (R-MO).
Rockefeller is quoted as saying that the Waxman-Hatch Act 180-day marketing exclusivity incentive to launch a patent challenge “is being widely undermined by authorized generics (which are) becoming even more prevalent as patents on some of the best-selling brand name pharmaceuticals expire.”
He says passage of his bill would “revitalize and protect the true intent of the 180-day marketing exclusivity period created in the Waxman-Hatch Act.”
In 2004, FDA denied two citizen petitions challenging the marketing of authorized generics. The agency determined that use of authorized generics during a period of marketing exclusivity was a long-standing pro-competitive practice that is permissible under the Federal Food, Drug, and Cosmetic Act. The petition decisions were challenged in court and FDA was upheld.
A 2009 FTC report found that drug prices are lower when authorized generics are marketed against a single generic drug than when they are not.