FTC Issues Interim Report on "Authorized Generic" Drugs
"The Federal Trade Commission today issued “Authorized Generics: An Interim Report,” which presents the first set of results from a study conducted to examine the short-term and long-term effects of “authorized generics” on competition in the prescription drug marketplace. An authorized generic exists when a pharmaceutical manufacturer sells a drug under both a brand-name and generic label. The FTC conducted the study in response to requests from Congress. Issues related to generic drug competition are relevant to current legislative debates and health care reform.

The FTC Interim Report examines the short-term effects of authorized generics during an initial period of generic competition. In certain circumstances, the first generic competitor of a branded drug is awarded a 180-day period of marketing exclusivity under the Hatch-Waxman Act. This marketing exclusivity period granted to certain generic “first filers,” however, does not preclude competition from authorized generics. It has become increasingly common for brand-name drug makers to begin marketing authorized generics at the same time the generic firm is beginning its 180-day marketing exclusivity period, leading to questions about the effects of authorized generics on pharmaceutical competition..."