It’s past time to modernize the FDA

With Congress back from its recess, there is no shortage of issues that need be addressed. Some, like health care and tax reform, are major undertakings sure to provoke strong opinions and require major bipartisan compromise. Others are less headline-grabbing but are both important and worthy of immediate bipartisan support.

Chief among these is long overdue modernization of the Food and Drug Administration. Like many federal agencies, the scope of the FDA has grown considerably in recent decades, with the agency having jurisdiction over a vast spectrum of products from the approval of vaccines, prescription drugs, and medical devices to sunscreen, food additives and tobacco products.

Like many agencies in Washington, as the FDA has grown it has suffered from an expanding and top-heavy bureaucracy and an increasingly outdated regulatory model. And, given its scope, it critical that the FDA operates as efficiently and effectively as possible. Moreover, making key changes at the FDA will allow us to at least make incremental improvements within our health care system.

What reforms are we talking about? To start, Congress should focus on the current timeframe surrounding prescription drug and vaccine approvals. As the ultimate arbiter of which treatments are approved for consumer use, and when that will be, the FDA holds considerable power when it comes to consumer health.

Sadly, bureaucratic delays in the approval process can have tragic consequences. For example, in 2014, 34 countries already had approved a vaccine for Meningitis B, a prevalent disease on college campuses, while the U.S. lagged behind in approval. That year, one U.S. college student died from the disease, two had feet amputated, and at least a dozen suffered major health complications. While we were able to successfully lead an effort to get the vaccine approved later that year, I remain heartbroken for the patients and families who suffered unnecessarily. We must be committed to ensuring the mistakes from the past are not repeated.

Similarly, the approval process for generic prescription drugs – medicines that have been tested extensively and proven as effective as the name-brand equivalent at significantly lower cost – come at far too slow of a pace under current practices. That needs to change.

We can make major progress in this area through two key reforms. First, the FDA should implement a policy of reciprocity approval with “A-list” foreign counterparts. If regulators from leading foreign nations – with whom we already work very closely on worldwide health issues — are able to review and approve safe vaccines and prescription drugs, we should take advantage of that expertise rather than start from zero every time.

Second, we should be granting more “accelerated approvals,” which are, in effect, limited or conditional approvals of new drugs that are intended for a “serious or life-threatening disease” and for which there is an “unmet medical need.” They can be based on clinical trials that do not yet show an improvement on a definitive health endpoint such as increased longevity, reduction in the incidence of heart attacks or cancer cure, but merely on a “surrogate endpoint” that is thought to correlate with actual clinical benefit. (Examples of surrogate endpoints include the shrinking of a tumor or improvement in a laboratory value such as “good” cholesterol.)

After an accelerated approval, the drug sponsor must perform trials to prove that the medicine is effective in meeting a definitive endpoint, at which time the approval is converted to a standard, unconditional approval. If the studies fail to provide such confirmation, the FDA can pull the drug from the market.

In addition to reforming how we approve vaccines and prescription drugs, we must also carefully examine the area of research funding. Like many of my colleagues, I strongly disagreed with the administration’s proposed funding cuts to the National Institute of Health earlier this year. As the nation’s premier funder of biomedical research, the NIH is an important tool in keeping our health care system at the forefront of health care innovation.

In my home state, which boasts the University of Minnesota – a nationally recognized health research facility – as well a world-class medical device industry, we know firsthand how cutting edge research is critical. The downstream effect of significantly cutting these funds would be disastrous, and I was proud to join a bipartisan majority in Congress to reject these cuts and actually increase medical research funding for the NIH this year.

At the same, there are significant ways to better prioritize how research dollars are spent. We can do this by redressing the funding of low-priority or even trivial research projects by components of the NIH and National Science Foundation. With the right priorities, we can continue to provide the substrate for advances in medicine, including, we hope, the “Next Big Thing”. That is what U.S. taxpayers want and deserve.

Congress should seize the opportunity to make that progress this year.

Paulsen represents Minnesota’s 3rd District.