Kennedy Enzi and the Bucks for Enforcement

One of the touted aspects of the not-yet-introduced Kennedy Enzi bill aimed at FDA reform is the provision that would allow the FDA to monitor and fine drug companies for failure to meet up with post-marketing commitments.  QDIS reported on this a few days ago. 

J0400307 The FDA has a LOT on its plate.  They are responsible for enforcing regulations from the remedies you buy over the counter, to your prescriptions, to your makeup, to your dog remedies and food.  It is a lot.  It takes a lot of money.

One of the solutions to the money challenge has been to raise PDUFA fees.  But consumer protection organizations protest the use of fees from industry to be put to use saying that fees from an industry to regulate that industry are an inherent conflict of interest.

That raisesa few questions for me. 

  1. Are PDUFA fees a conflict of interest?  It gets thrown around a lot, but until there is some evidence that this is the case, should we refrain from expanding those fees for enforcement purposes.  If consumer groups are going to use this argument, it seems they need data to support it, or from a public affairs perspective, it is just talk. 
  2. There are a LOT of proposals to use PDUFA fees to fuel a greater ability of the FDA to patrol various aspects of regulation.  What is the breaking point? 
  3. When does government obligation kick in?  If the government is going to mandate regulation, what is the role of government to pay for it?

There is a rush to reform FDA given the climate of risk over benefit for pharmaceutical products.  But it would be prudent to first of all, remember benefit as a factor and second of all, to put some hard thinking into the long-term consequences of broad expansions merely for the sake of short-term solutions.  Every dollar taken away from pharmaceutical companies is potentially a dollar taken away from research for future cures.  Granted, it is also a dollar taken away from marketing.  But we should know what we are getting into with an expanded structure before we erect it.  That would be a good lesson for this government in many other arenas as well, not just healthcare. 

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