the context of publicly-held pharmaceutical companies who fail to disclose
relevant information or who publicly misrepresent their dealings with the
There are good reasons to make interagency collaborations, both of this
and other types, more transparent. First, transparency about agency priorities
and enforcement is important to ensure public accountability. These agencies
already issue guidance documents (such as the FDA’s guidance documents
on the regulation of mobile health apps) and rulemakings for public comment
for similar reasons.108 Second and possibly more importantly, transparency
about areas of collaborative focus helps scientists and the industry in general
plan for the future. The primary point of these collaborations is to improve
both regulatory priority-setting and the regulatory process itself, and
scientists who are aware of these priorities will make decisions about what
technologies to develop and how those technologies will come to market in
a more informed, appropriate fashion.
Of course, in many cases collaboration does not occur, even where it might
be desirable. There are a range of reasons why this might be true. It may be
that one agency’s governing statute formally precludes its action or even its
collaboration with other agencies on specific issues. For instance, the FDA
may hope to regulate in an area, but be hamstrung by its own jurisdictional
limitations, as some of the functions implemented by mobile apps may fall
under its “practice of medicine” exception.109
More commonly, though, the explanation for the failure to collaborate may
be less about legal barriers and more about practical obstacles. It is costly—
in terms of time, energy, and agency resources, if not in terms of financial
resources—to develop and maintain interagency collaborations.110 Unless
staff members have support from agency leaders, it may be difficult for them
to identify their counterparts in the relevant agencies, formulate plans for
collaboration, and implement those plans.
Helpfully, there are a range of potential procedural mechanisms that could
be employed to enhance cooperation between different administrative
agencies for the purpose of promoting both innovation and regulation. Many
107. Liora Sukhatme, Deterring Fraud: Mandatory Disclosure and the FDA Drug
Approval Process, 82 N. Y.U. L. REV. 1210, 1234–36 (2007).
108. See generally, CARY COGLIANESE, HEATHER KILMARTIN, AND EVAN MENDELSON,
UNIV. OF PA. LAW SCH., TRANSPARENCY AND PUBLIC PARTICIPATION IN THE RULEMAKING
A NONPARTISAN PRESIDENTIAL TRANSITION TASK FORCE REPORT (July 2008).
109. See, e.g., Patricia J. Zettler, Toward Coherent Federal Oversight of Medicine, 52
SAN DIEGO L. REV. 427, 430 (2015).