FTC Releases Additional Public Comments on its Authorized Generics Study
The FTC has posted additional public comments relating to its proposed authorized generics study on its website. One main goal of the proposed study is to determine whether expected price competition from authorized generics during the 180-day marketing exclusivity period discourages generic drug makers from filing ANDAs in the first place. The proposed study would call for production of extensive information and documents on recent generic entries.
In addition to comments previously reported on Orange Book Blog, new comments available on the FTC website include those from innovator drug companies, generic drug companies, and consumer advocacy groups:
- Actavis Group
- Consumer's Union
- Eli Lilly & Co.
- Gilbert's LLP
- IMS Health
- PhRMA
- Prasco, LLC
- Ronald Davis (on behalf of an unnamed client)
The new comments are based on sharply divergent assumptions, including:
- all authorized generics are anti-competitive;
- authorized generics within the 180-day exclusivity period are anti-competitive;
- the 180-day exlusivity period itself is anticompetitive; and
- authorized generics are pro-competitive.
The comments from innovator and generic drug companies generally assert that much of the information the FTC proposes to collect in reviewing authorized generic agreements is irrelevant to the competitive effects of authorized generics and would be unduly burdensome to comply with. Various modifications to the FTC document requests are proposed.
New comments from consumer groups urge the FTC to vigorously pursue the proposed document collection effort.
NOTE: this post was written by David Harper
RELATED READING: 19 June 06 Antitrust Review post on Lilly's comments
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