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Thursday, May 03, 2007

Opinions on PDUFA Reauthorization

Both The New York Times' and The Washington Post's editorial boards have weighed in on the Senate's Prescription Drug User Fee Act (PDUFA) reauthorization.

The Times brings us back to the crux of the issue: FDA's power to require the drug industry to pay for drug approvals. While these so-called user fees are an significant source of revenue for FDA, The Times articulates the concerns of many who are following the issue:

This is a dangerous dependency for an agency that regulates such a critical part of the nation's health care system. It's as if the nuclear utilities paid for oversight by the Nuclear Regulatory Commission. The potential for abuse in such a chummy atmosphere is clearly there.

Nonetheless, the reauthorization contains other valuable provisions and has almost unstoppable momentum. That is, unless President Bush decides to veto it.

Which brings us to The Washington Post editorial. In today's paper, The Post puts on its protectionist cap, opposing a possible amendment to the lesgislation which would allow importation of cheap drugs from Canada and the EU (see Reg•Watch's coverage from yesterday).

The Post also defers to the White House on the issue:

Further, President Bush has threatened to veto the bill if it contains such language. For the sake of common sense, and to enhance the chances of urgently needed legislation, the Senate should reject the importation amendment before passing the bill.

In other words, "This is too important an issue to question Presidential authority." Isn't that the kind of logic The Post used in the run-up to the Iraq invasion?

The Senate is set to hold a cloture vote on the drug importation provision today. Stay tuned to Reg•Watch for more.

UPDATE:The Senate approved cloture 63-28, ending debate on the amendment.



Posted by Matt Madia



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