Democrats play dangerous game with FDA reauthorization
Democrats play dangerous game with FDA reauthorization
Prescription bottles and pills on a counter.

If ever there were a time to ensure the Food and Drug Administration could continue performing its most basic duties, now, amid two public health crises, would be it.

Democrats don't appear to see things that way. With just days to go before a Sept. 30 deadline, they've effectively blocked the reauthorization of a critical FDA funding bill in an attempt to lard it up with some of their long-standing, and ill-advised, policy priorities. At issue is the Prescription Drug User Fee Act, or PDUFA, which allows the FDA to collect various fees from drug manufacturers. The revenue helps the agency hire staff dedicated to reviewing drug applications.

It has played a key role in cutting the median length of the approval process to 10 months — down from 29 months when PDUFA was enacted in 1992. Historically, lawmakers have viewed the reauthorization of PDUFA as must-pass legislation. So it's generally attracted bipartisan support when it comes up for renewal every five years. This year, though, Democrats are holding the measure hostage. They're trying to graft on provisions that would allow the importation of prescription drugs from Canada and would hamper the FDA's accelerated approval pathway.

The latter could threaten patients' ability to access life-saving medicines. The former provision, by contrast, is infeasible. Some innovative drugs are not available in Canada. The country's Patented Medicine Prices Review Board does not cover all the drugs available in the United States because it deems some too expensive. There are also significant differences between the House and Senate versions of the user fee bill. Congress has less than two weeks to reconcile those differences before the end-of-September reauthorization deadline.

The consequences of delaying PDUFA's reauthorization would be severe. User fee revenue makes up 60% of the FDA's drug review budget and provides for thousands of critical jobs. Absent timely reauthorization, funding from last year would only last five additional weeks. That would force the agency to lay off staff charged with ensuring the safety, efficacy, and swift approval of medications. People waiting for life-saving drugs would wait even longer .

The last thing patients need is a slower FDA approval process. PDUFA can't be a casualty of partisan brinkmanship.

Sally C. Pipes is president, CEO, and Thomas W. Smith fellow in healthcare policy at the Pacific Research Institute. Her latest book is False Premise, False Promise: The Disastrous Reality of Medicare for All (Encounter 2020). Follow her on Twitter @sallypipes.

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