



Advocates for greater research funding yesterday mostly cheered the release of a “discussion draft” version of a bill in Congress that would give the NIH $10 billion in additional funds over the next five federal fiscal years.

The bill, dubbed the 21st Century Cures Act, would parcel out that $10 billion into annual $2 billion allocations to a new “NIH Innovation Fund” separate from annual appropriations. The discussion draft says the funds would have to be spent on priority areas that include funding young researchers—a longstanding challenge for which a new NIH program would be established.

“These additional dollars can empower NIH to sustain and embark on innovative studies that could reduce the prevalence and impact of costly and disabling conditions that continue to threaten individual and population health, our economic security, and global competitiveness,” Mary Woolley, president and CEO of research advocacy group Research!America, said in a statement.

Sara Radcliffe, president and CEO of the California Healthcare Institute (CHI), stated separately: “We applaud the inclusion of meaningful funding increases and reforms that will bolster federal research efforts at the National Institutes of Health (NIH), and important proposals to modernize regulatory and payment mechanisms to ensure enhanced development of and access to needed medicines and technologies for the future.

21st Century Cures Act is the subject of a hearing today by the health subcommittee of the House Energy & Commerce Committee. Scheduled to give testimony are Kathy Hudson, Ph.D., NIH’s deputy director for science, outreach, and policy; and two FDA officials: Janet Woodcock, M.D., director of the agency’s Center for Drug Evaluation and Research, and Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health.

The discussion draft enjoys support from committee Chairman Rep. Fred Upton (R-MI) and ranking member Rep. Diana DeGette (D-CO). The bill would reauthorize NIH funding for the 2016 through 2018 fiscal years with increases each of those years of $1.5 billion. The NIH now operates on an annual budget of $30.3 billion, and President Obama proposed increasing that by $500 million in the budget he proposed for FY2016 back in February.

The legislation also requires FDA to promote greater use of patient experience data in regulatory decision making; advance precision medicine by issuing and updating guidance identifying population subsets; and support public-private efforts by industry, research institutions, and patient groups to speed up clinical trials through alternative clinical trial designs, biomarkers, and surrogate endpoints.

“We are pleased that the discussion draft prioritizes placing patients at the center of the drug development process, which we believe will help spur the development of therapies for the most prevalent conditions, as well as encourage development of treatments focused on unmet medical needs,” Jim Greenwood, president and CEO of the Biotechnology Industry Organization (BIO), said in a statement.

“We strongly support establishing a framework for incorporating patient views into the development and regulatory review processes in a more structured and transparent way, both with respect to patient input for benefit-risk assessments and use of patient experience data in regulatory decision-making,” Greenwood added.

Added Pharmaceutical Research and Manufacturers of America (PhRMA) president and CEO John J. Castellani in a separate statement: “We share the Committee’s interest in modernizing the FDA’s regulation of health care communication to ensure health care providers have access to scientifically accurate and up-to-date information in order to achieve the best possible outcomes for patients,”

Castellani said PhRMA supported the goal of the NIH planning provisions: “We support more effective collaborative efforts within the institutes and centers of the [NIH] to ensure the groundbreaking basic research done by NIH is shared and translated into practical applications for the ongoing medical research, discovery, and development done in the private sector.”

Not all provisions of the discussion draft are universally applauded. For example, the draft also requires NIH to complete a five-year “research strategic plan” that identifies areas of focus, along with objectives, where agency resources “can best contribute to the goal of expanding knowledge on human health in the United States through biomedical research.”

The idea received a cool reception last month from the Association of American Medical Colleges (AAMC), which noted that each of NIH’s 27 centers and institutes already produce five-year plans: “The AAMC is unconvinced that an overarching NIH strategic plan will enhance fiscal or scientific efficiency, transparency, or accountability sufficiently to merit the considerable time, effort, and resources NIH and the community would need to devote,” Ann Bonham, Ph.D., AAMC’s CSO, wrote in a March 18 letter to Reps. Upton and Degette.

But in a statement yesterday, AAMC President and CEO Darrell G. Kirch, M.D., said the association was still reviewing the draft, and focused only praise on the extra NIH funding:

“We are encouraged the committee leadership recognizes the critical importance of maintaining NIH as a national priority. NIH funded-research is essential if we are to continue to improve our nation’s health, sustain our leadership in medical research, and remain competitive in today’s global information and innovation-based economy,” Dr. Kirch said. “Research means hope for patients and families suffering from serious illnesses such as cancer, diabetes, Alzheimer’s, depression, and Parkinson’s.



























