A New Twist in the Cost Curve - Pharmaceutical Executive


A New Twist in the Cost Curve

Pharmaceutical Executive

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


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