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79 Md. L. Rev. Online 1 (2020)

handle is hein.journals/endnot79 and id is 1 raw text is: 








THE BURDEN ON SOCIETY FROM ELEVENTH-HOUR CITIZEN
         PETITIONS FILED TO SLOW GENERIC DRUGS
                           ROBIN FELDMAN*

ABSTRACT

       The Food and Drug Administration's citizen petition process
     provides an avenue for ordinary citizens to raise concerns and
     participate in the regulatory process. Abuse of that process has
     been documented as an example of the legal maneuvering used by
     pharmaceutical companies to protect their brand-name drug
     revenue streams from the introduction of low-cost generics. To
     date, the financial cost to society of these delays has not been
     calculated in the literature, which likely hinders the push for
     policy solutions. Drawing from a previously published data set
     on 249 citizen petitions, this Article will identify four petitions
     that were highly likely to have been the final obstacle to a generic
     drug entering the market. Specifically, the petitions were denied;
     the FDA approved the generics within one business day of
     denying the petitions; and the generics came to market within one
     week of the FDA's approval, signaling that the petitions were the
     final obstacle standing in the way of the generic's entry to
     market. Using these four dubious citizen petitions, this Article
     will find that the total financial cost to society from citizen
     petition delays was $1.9 billion or $3.6 million per day.' The
     total financial cost to government-provided insurance programs
     in the same period was roughly $782 million. This Article will
     employ a conservative methodology (choosing only four petitions
     that meet the criteria of but for this citizen petition, the generic
     would have gone to market). Thus, the estimates are likely low.
     Citizen petitions that contributed to a generic delay as one of
     many tactics or for which there was not sufficient volume and
     usage information were eliminated from consideration in this
     estimate.


© 2020 Robin Feldman.
    * Arthur J. Goldberg Distinguished Professor of Law, Director of the Center for Innovation
(C4i), University of California Hastings Law. I wish to thank Ramy Alsaffar, Colin Burke, Nick
Massoni, Sophia Tao, and David Toppelberg for invaluable research assistance. This project was
funded in part by a grant from the Laura and John Arnold Foundation.
    1. See infra Section I.B.
    2. See infra Section I.B.

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