Tackling Administrative Waste: The Promises Of Data Science For The FDA

Our healthcare system needs an overhaul in lots of areas and the FDA is not exempt. It’s slow, expensive, and cumbersome. Modernizing the FDA is now the focus of several initiatives including ones from Congress and the Bipartisan Policy Center. One of the top priorities: using data to speed the drug approval process without sacrificing safety.

In looking at the $2.8 trillion a year—20% of our Gross Domestic Product—that our nation spends on healthcare, we see that about $900 billion of that is waste and $248 billion can be attributed to administrative complexity. This costly complexity stems from the ACA, insurance regulations, and regulatory agencies in the U.S., including the Food and Drug Administration (FDA). The FDA in particular is a needed and valued part of healthcare in this nation – it just needs a serious overhaul.

The innovation bottleneck at the FDA has a real impact on Americans’ healthcare. One of every $4 spent by consumers each year is on an FDA-approved product, including drugs, devices, food, and tobacco. Expensive development and approval processes drive up those costs with an average drug taking about $1 billion and a decade to make it to market. With increased consumer cost-sharing, expensive drugs and devices are already becoming out of reach for many Americans. And for those facing a disease with potential life-saving treatment in trials, the clock is ticking entirely too slowly.

Thankfully, modernizing the FDA has become a key focus for Congress this year. I am leading an initiative through the Bipartisan Policy Center, a non-profit think tank in Washington, DC, focused on reversing this cost trajectory to improve affordability and availability of healthcare. We are working on strategies to advance medical innovation within the FDA, while reducing the time and cost associated with drug and device development.

One area I think shows significant promise is the use of “big data”.

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