Regulator versus Gatekeeper
The bottom line is the notion that the agencies are about to cross the bright line that until now has separated the regulator
(FDA) from the purse-string gatekeeper (CMS). Despite the import of this proposal, public comment has not been requested as
to whether the agencies should proceed. Comment is only requested as to how they should proceed. Nor have public hearings been held to air the issues and concerns inherent in the proposed collaborative
effort. Yet the agencies are moving forward.
The sole rationale—market predictability—is a fragile basis for moving forward. Once the wheels of government have been set
in a new direction, the unintended consequences are likely to be substantive—at least for industry. Through the rhetoric of
the moment, one thing should not be lost sight of, namely that CMS does deny or at least limit—at times severely—market access
for FDA-approved products.
Moreover, as health reform implementation gathers momentum, the role of CMS as gatekeeper will become more prominent and more
politically driven. It will increasingly leverage its role in the premarket development and review process at FDA. New product
development will be driven by what CMS is likely to reimburse. This may or may not be an unintended consequence of what is
now called a "voluntary program."
Finally, we live in a global village, and the drug regulatory community is no exception. Look for awareness to build on what
the FDA and CMS have just done and for other countries to see parallel review as another application of the US "gold standard"
they seek to emulate.
Ansis Helmanis is a former FDA official and founder of RegLink Associates. He can be reached at ansis@reglinkassociates.com
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