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May 24, 2012

Why Mess with the Success of PDUFA?

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At a time when Congress can find very few issues on which there is widespread bipartisan support, it is important to act quickly and decisively when it does. One of those issues is currently before the Senate, the Food and Drug Administration Safety and Innovation Act, or FDASIA (S. 3187), a reauthorization and update of the Prescription Drug User Fee Act, or PDUFA.  

It’s easy to see why PDUFA has had a history of bipartisan support. In the early 1990s the waiting time to get a new prescription drug through the Food and Drug Administration’s (FDA) approval process had grown to some 30 months. That delay: 

  • Robbed patients of access to important new drugs in a timely manner;
  • Increased the cost of creating a new drug because it delayed the time when innovator drug companies could begin to sell it; and
  • Nibbled away at the limited patent time available to the innovator.

To address the problem, Congress passed PDUFA, which allows companies to pay the FDA an additional fee to expedite the process. With the additional funds, the FDA was able to hire more staff to do the needed work. The result was that review times have decreased by about 60 percent. 

PDUFA’s success is remarkable and should be allowed to continue, which is why proposed amendments to FDASIA should be postponed for consideration another day. One such amendment is offered by Senator Bernie Sanders of Vermont. 

The Sanders’ amendment is supposed to help crack down on fraud with respect to prescription drugs, penalizing drug manufacturers found guilty by revoking the drug’s data exclusivity period. But this is a major penalty imposed for what might be a minor or even unintended infraction. In other words, in the vast majority of cases the penalty would far outweigh the alleged misdeed.  

In addition, there are already statutes on the books to punish real infractions. Even supporters of the Sanders amendment concede that there has been an increase in settlements and convictions. Why mess with success? 

FDASIA represents an important step forward in updating PDUFA, and it was hammered out in bipartisan fashion. It may be one of the few bills that can pass the currently divided Congress.  

Given the significant challenges facing the Congress over tax and budget issues, and the time it will need to reach a resolution, the Institute for Policy Innovation believes it would be better to leave good enough alone with respect to FDASIA, get a bipartisan accomplishment under its belt, and move on to the more daunting economic issues that Congress must address.  

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