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Trump’s Proposed Budget Would Cripple the NIH and FDA

This article by Ellen V. Sigel, Ph.D., was originally published in STAT (https://www.statnews.com/) on May 24, 2017. Ellen V. Sigal is founder and chair of Friends of Cancer Research, (https://www.focr.org/ ) an advocacy organization based in Washington, D.C. BioQuick News ran into Dr. Sigel at the recent Precision Medicine World Conference (PMWC 2017) at Duke May 24-25, and received permission to reprint this important opinion piece: Since taking office, President Trump has done right by the scientific and patient communities by placing strong leaders at the Food and Drug Administration and the National Institutes of Health. After a four-month vacancy in the FDA’s top job, Dr. Scott Gottlieb now runs this essential agency, and Dr. Francis Collins is continuing his leadership of the NIH. With these experienced and thoughtful leaders in place, there is reason to be optimistic that the progress promised by the passage of the 21st Century Cures Act in December 2016 will be fully realized. But the president’s newly released budget seems to move in the opposite direction. It would hamstring Collins and Gottlieb in their efforts to protect and improve the lives of Americans and represents a major impediment to bipartisan opportunities to build on the momentum and execute the programs created through Cures Act and the current reauthorization of the Prescription Drug User Fee Act. At best, the proposed budget suggests that the White House doesn’t understand how the NIH and the FDA function. At worst, it suggests a disregard for the millions of patients who are desperate for the scientific innovations, lifesaving therapies, and safeguards that emerge from these agencies. Cutting the NIH by the magnitude currently proposed — a staggering $6 billion — would cripple the incredible scientific momentum the health care community has been enjoying.

Over the past decade, increases in funding have allowed the NIH to provide grants to researchers across the country that have led to breakthroughs in how we treat cancer and have brought us into the era of precision medicine. Cutting the funding lifeline for so many labs and medical centers across the country will not only cost thousands of Americans their jobs but will impede progress toward cures for cancer and many other diseases.

At first glance, it may seem that the proposed budget does not significantly cut FDA funding. But look closer and it becomes clear the proposed cuts do, in fact, run deep, with a proposed reduction of nearly $1 billion.

The budget contemplates propping up the FDA by increasing user fees from pharmaceutical companies. The private sector, however, already supports a significant portion of FDA’s drug review. Asking industry to fill the gap created by cutting federal spending will render the FDA unable to properly execute its vital work for patients. It’s surprising that the business-friendly Trump administration would expect private companies to shoulder the burden of critical public health programs, such as monitoring the safety of drug supply chains, managing drug shortages, and overseeing compounding facilities. It seems to show a lack of knowledge on the part of the administration on the appropriate use of user fees and the scope of the FDA’s work in ensuring the safety of Americans.

If this misguided budget is passed, not only would it jeopardize the gold standard of scientific excellence that the FDA has worked tirelessly to maintain, but we would also miss out on the frontier-expanding opportunities for the FDA and NIH made possible by the passage of the Cures Act.

The proposed budget, combined with the Trump administration’s unjustified and foolish hiring freeze, will worsen the understaffing that already hinders the FDA’s work. With FDA vacancies already north of 500, this budget goes in the wrong direction, especially for an agency that is so vital to ensuring that the American public has access to effective and safe treatments.

Both Gottlieb and Collins have the savvy and wherewithal to maintain their agencies’ world-renowned standard of excellence while implementing the new initiatives envisioned by the 21st Century Cures Act. As a country, we should be proud of the amazing work done by their dedicated staffs. We need the president to properly fund the FDA and NIH, giving them the resources they need to excel, not tearing them down with a budget that cuts to the bone.