Four Proposals to Enhance Generic Competition (Presentation Slides)

FDA Testimony (2017)

9 Pages Posted: 18 Jul 2017

Date Written: July 17, 2017


As part of the FDA's hearing on "The Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access," I offer testimony that does two things.

First, it shows how the balance has tilted away from generic access, pointing as examples to settlements, product hopping, REMS patents, and citizen petitions.

Second, it offers four solutions:

(1) clarifying that REMS patents should not be listed in the Orange Book,

(2) offering ideas to expedite shared REMS negotiations,

(3) loosening the distribution-restriction bottleneck, and

(4) addressing the harms from citizen petitions.

Keywords: pharmaceuticals, drugs, generics, patents, REMS, citizen petitions, Hatch Waxman

JEL Classification: I18, K21, L40, L41, L43, L65, O34, O38

Suggested Citation

Carrier, Michael A., Four Proposals to Enhance Generic Competition (Presentation Slides) (July 17, 2017). FDA Testimony (2017), Available at SSRN:

Michael A. Carrier (Contact Author)

Rutgers Law School ( email )

217 North Fifth Street
Camden, NJ 08102-1203
United States
856-225-6380 (Phone)
856-225-6516 (Fax)

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