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It’s PDUFA Time

By July 27, 2010July 9th, 2019Uncategorized

Back in April, the Senate passed a bill that included a reauthorization of the Prescription Drug User Fee Act (PDUFA) for five more years, and the House is set to take it up soon. So what is PDUFA and why should you care?

In short, you — and the pharmaceutical companies — have a lot riding on it. PDUFA first was passed in 1992 to help the FDA review drugs more quickly and get them out to patients sooner. It created a “user fee” that a company pays when it submits the large volume of research the FDA must review before approving or rejecting a drug, essentially paying the FDA to speed up its decision making process. The biggest question as Congress debates reauthorizing the law is if FDA should raise the fees and use a larger portion of that funding to look at drugs after they’ve been approved and gone to market.

Back in 1992, drug companies were screaming that it took far too long to get their drugs to market — particularly because it cut into the time a drug was under patent. Consumers also were lobbying for new drugs to be made available in a more timely fashion. (Of particular concern at the time were AIDS drugs.) Once passed, PDUFA was hugely successful, cutting the time almost in half for many drugs to hit the market. About 50 percent of all new prescription drugs now are available in the U.S. first vs. just eight percent before PDUFA. Pharmaceutical companies’ profits have soared because of it.

However, that speed of approval also is viewed by many as the main downside of the law. Drugs like Vioxx, Ketek and now Avandia are looming large in the new debate. All three of these drugs ran into problems after the FDA approved them. The possibility of heart attacks or liver failure weren’t discovered in connection with these drugs until they had been approved and were in use in large numbers. So now many are calling on increasing the fees to cover the costs associated with follow-up on approved drugs. Some have argued that computer programs could mine huge databases like those of Medicare and HMOs to find potential problems with drugs on the market much more effectively than waiting for random doctors’ reports — or lawsuits — to trickle in.

PDUFA has been a very effective law, but we must watch closely to see if it is updated to fix some of its shortcomings.