As nearly everyone who follows FDA knows, the Prescription Drug User Fee Act (PDUFA) is up for reauthorization. Without passage, this mechanism for funding many jobs and programs at the agency disappears in September. That makes it an important order of business for the Congress.
But, as is common, it also makes the legislation an important vehicle for members of Congress to attach amendments which achieve other ends. For PDUFA, there has been talk of attaching many different amendments and yesterday – by a vote of 48-40, one that would allow for the importation of drugs was piled onto the PDUFA cart.
The PDUFA legislation is more than a bill for renewing FDA funding, it already has so many new provisions in it, the media often refer to it as the "FDA Reform Bill". The imperative nature of the funding, along with the proposed changes on FDA operations contained in the bill are imperative and also complex. The bill, for that reason, should be left unimpeded by other, sometimes controversial and complex issues.
The drug importation amendment is a good example of the kind of issue that should be considered on its own, and not amended to the PDUFA bill. Drug importation by itself is opposed by this Administration and the White House has said it would not support a measure unless it contained a provision for Health and Human Services to deny importation unless drugs are deemed "safe". Many see that as a "poison pill" provision, because this Administration would probably not deem any imported drug source as safe. In the end, nothing gets accomplished except for the possible delay of PDUFA by attaching amendments that are controversial, but in the end, without substantive impact.
The PDUFA apple cart has enough burden to carry and should be left alone so that it can pass, or not, on its own accord.
Great point, Mark!
Importation fans tried to slip this one through. By all means, we should have a good open debate about the pros and cons of importation rather than slowing down the PDUFA.
But keep in mind that much of the regulatory burden of S.242 will fall on an already burdened FDA.
I predict importation will be back — see my blog: