Getting medicines to patients faster is a political win for both parties

The next few weeks will likely produce one of two outcomes in the now eight-year-long healthcare debate: Republicans will find the votes necessary to “repeal and replace” the Affordable Care Act (ACA) or they will make minor adjustments and be forced to explain why a Congressional majority couldn’t produce broad-scale reform.

Either way, the idea that healthcare will be in the rear-view mirror is a mirage — as we’ve seen in town hall meetings and throughout the halls of Capitol Hill office buildings, the votes that will be cast in July and August will resonate long after.

As someone who served in the House of Representatives for eight years, I can say with a high degree of certainty, regardless of party affiliation, that this debate will get worse before it gets better; one partisan healthcare vote tends to beget another. This creates a battle that will take up time as the bill is passed through the legislative branches.

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This increases the importance of pursuing meaningful, nonpartisan healthcare policy whenever the opportunity arises. The House of Representatives passed the Food and Drug Administration (FDA) Reauthorization Act, which includes user-fee programs for prescription and generic drugs, medical devices and biosimilars. The Senate needs to pass it now.

 

Since 1992, PDUFA, in particular, has played a critical role in helping the FDA become a gold standard agency for the rest of the world. According to a recent report by the Information Technology and Innovation Foundation (ITIF), the pharmaceutical industry invested 50 percent more in Europe compared to the United States as recently as 1990. The numbers have flipped in the decades since.  

Why prioritize the FDA user-fee package? To begin with, constituents will expect progress that can be tied to tangible policy results. One of Congress’ more recent accomplishments — 21st Century Cures — passed the House 392-26 and the Senate 94-5. It was the product of genuine bipartisanship with the Democratic and Republican leaders of the House Energy and Commerce and Senate Health, Education, Labor and Pension committees putting aside differences on healthcare policy to find common ground.

As a result, the FDA has fewer regulatory hurdles to get medicines to those who need them, patients are closer to the development process, states have access to funding sources to address the opioid epidemic, and generics will be approved faster, which increases marketplace competition.

At a time when medical discoveries are accelerating, we need an FDA that is fully equipped to review and approve them. For all intents and purposes, it’s a central part of our national healthcare strategy to ensure that we’re treating chronic disease and helping working Americans get the care that they need. Separately, the fact that Congress is increasing resources for generic drug reviews illustrates the recognition on the part of lawmakers that we need every tool in our arsenal to help patients.

There’s also a dark reality to failing to act on the user-fee package before the current PDUFA law expires in September: it would essentially grind the FDA to a halt at the worst possible time. In 2007, when reauthorization of the law remained uncertain in the final weeks, the agency was prepared to distribute pink slips (not by choice, but due to lack of funding). The last thing we need at the FDA is a preventable brain drain that delays the review of new medicines.

Healthcare will always be a partisan and messy policy issue. We’re about to be reminded why this is.

On the other hand, policies like FDA user fees bring out the best in both parties. If I were in Congress today, I’d certainly want to go home to my district and talk about how I was helping to get medicines to patients faster.

Ron Klink is a former Democratic congressman from Pennsylvania and is currently senior policy adviser at Nelson Mullins Riley & Scarborough LLP. 


The views expressed by contributors are their own and not the views of The Hill.