Authorized Generics: The Subpoenas Are Coming – Eventually

By Richard Liebeskind and Steven A. Dahm

June 6 Deadline to Comment on FTC Proposal

The Federal Trade Commission "FTC" has authorized the staff to use compulsory process to collect the information needed to study the likely short- and long-run effects of entry by authorized generics on generic competition. In doing so, the FTC is acknowledging the debate about whether the use of authorized generics by branded pharmaceutical companies reduces the incentives for generic entry created by the Hatch- Waxman Act.

Under the Hatch-Waxman Act, the first Paragraph-IV ANDA filer is entitled to a 180-day exclusivity period upon entry into the market. The 180-day exclusivity was created to give generic companies an economic incentive to develop generic products and take the legal risks related to challenging patents and possibly infringing. The stay is valuable to generic companies because of the greater revenues and the opportunity to establish a larger marketshare. Recently branded