A Unique Opportunity to Support a Stronger FDA in 2017

Although healthcare isn’t dominating the national dialogue as it has in previous cycles, the reality is that many policymakers continue to work to advance proactive initiatives. A new conversation now exists about the importance and timeliness of medical discovery and how we can ensure that we’re meeting the needs of patients.

As we build on this momentum, we have an opportunity to bring Democrats and Republicans together in support of public policies that enhance the ability of the U.S. Food and Drug Administration (FDA) to review and approve new medicines in a timely manner. Contrary to the very public views of many critics, the FDA has improved significantly over the past two decades, although more remains to be done.


Since its creation nearly a century ago, the FDA has been instrumental in protecting public health and safety by regulating foods, biopharmaceutical products and medical devices, to name a few.

In 2015 alone, the FDA approved 45 new medicines. For cancer, specifically, the agency approved 51 new medicines in just a four-year period, from 2009 to 2013. Currently, there are 836 cancer medicines and vaccines in the clinical trial phase or awaiting FDA review.

A key reason for the improvement in the agency has been the development of a steady and reliable funding source, which, when added to annual appropriations, creates the resources needed to bring new medicines to patients in a timely manner. The Prescription Drug User Fee Act (PDUFA), a critical program that has been supported by Congressional leaders on both sides of the aisle, was originally passed in 1992. Before PDUFA was enacted, it took the FDA over two years to review drug applications. In the more than 20 years that PDUFA has been in existence, the FDA has approved over 1,500 new medicines.

With PDUFA VI up for reauthorization in 2017, we can build on this progress. By embracing approaches like patient-focused drug development and the use of real-world evidence, we will improve the review and approval process, as well as drive greater efficiencies. Real-world evidence, in particular, involves the analysis of data and patient experiences outside of clinical trials, which could lead to a fuller understanding of the value of every medicine.

We haven’t recently achieved much consensus in policymaking, particularly in healthcare policy. However, the process by which PDUFA takes shape involves stakeholders across healthcare coming together over a period of many months to discuss how it ultimately helps patients.

With new treatments on the horizon, we ought to recognize and seize the potential to come together and reauthorize PDUFA with a strong bipartisan majority. In doing so, we will ensure that the FDA continues to have unparalleled scientific expertise, the best and latest technology as it reviews innovative medicines, and the brightest talent to help support this new era of medical discovery.

Howard Dean is the former governor of Vermont and a former Democratic candidate for President of the United States. Dean currently serves as a senior advisor at Dentons, however the views here do not represent the firm or its clients.

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