The 21st Century Cures Act – which is receiving uncharacteristic bipartisan support – could restore many of the Ophthalmology-oriented research grant programs cut in recent years.
By a 51-0 vote in May, the House Energy and Commerce Committee endorsed the increase of overall National Institutes of Health funding by $1.5 billion a year over each of the next three fiscal years, and provide an additional $10 billion over the next five years for the NIH Innovation Fund.
“A rising tide lifts all boats, so increased NIH funding ideally would mean additional funding for all the institutes and centers,” says James Jorkasky, Executive Director of the National Alliance for Eye and Vision Research (NAEVR).
But more funding for the Innovation Fund holds particular promise for medical innovators. “When you take a look at, for example the discussion in legislation for the new Innovation Fund, three areas they described are emerging scientist, high-risk, high-reward research and big-ticket infectious diseases,” Mr. Jorkasky says. “There’s opportunity there for vision researchers: obviously emerging scientists, the high-risk, high-reward area and even the visual implications of some of these infectious diseases.”
A few hurdles remain before the funding actually arrives. The full House has to vote on the bill, and the Senate, where the Health Education and Labor and Pensions Committee is coordinating legislation with the House committee, must also pass it. Then there’s the matter of actually getting the appropriations from Congress; 21st Century Cures is merely an authorization, not an appropriation.
The potential for restoring funding for medical research would reverse a devastating trend over the past decade, says Robert Eugene Anderson, MD, PhD, director of research at Dean McGee Eye Institute at the University of Oklahoma and a longtime advocate for vision research with the Association for Research in Vision and Ophthalmology (ARVO). “As far as the NEI is concerned, we’ve gone from more than 1,200 to a little more than 1,000 R01 research grants today; that’s about a 15% cut,” he says. R01 is a category of grant that allows an investigator to define the focus of the research.
“That’s probably picking up ground that we lost,” Dr. Anderson said of the restored funding—if it makes it through appropriations.
The 21st Century Cures Act would also require the NIH to draft a strategic plan and give the National Center for Advancing Translational Science (NCATS) more flexibility so it operates more like the Defense Advance Research Project Agency (DARPA). It would also remove a restriction on NCATS’ grants for phase II and III clinical trials and support research that involve high-risk ventures but have the potential to lead to breakthroughs.
Another section of the act would address how the FDA does its business. For example, it would direct the FDA to establish a framework for incorporating patient experience data into the regulatory decision-making process, including the assessment of desired benefits and tolerable risks associated with new treatments.
It would also require the FDA to issue guidance to assist in the development of biomarkers. This section would facilitate early interactions and agreement between sponsors and FDA on designing studies to generate evidence for purposes of accelerated approval.