The appropriations committees in the House and Senate have finished “marking up” their fiscal year 2019 (FY19) spending bills and, when it comes to our nation’s health and science focused agencies, the news has been largely positive. Of particular note, the Senate provided an increase of $2 billion for NIH and, net of transfers and one-time funding, provided a $695 million increase for CDC. The House provided a $296 million increase for FDA as well as a $408 million increase for NSF. Both the House and Senate provided $334 million – the same level as FY18 – to AHRQ, but explicitly rejected calls to roll the agency into NIH. 

While both Houses have made significant progress in their respective appropriations efforts, it remains unlikely that the process will be complete by the September 30 end of FY18.  We anticipate at least one and potentially several continuing resolutions flat-funding the government before final FY19 budget numbers are signed into law.

As the bills for FY19 were being drafted and sent for mark up, Congress was simultaneously working to address the administration’s rescissions package, which called for impounding and ultimately cutting $15.4 billion in unused discretionary and mandatory spending authority. Two areas of particular concern in the package were cuts of $400 million in USAID Ebola funding and $800 million in Center for Medicare and Medicaid Innovation (CMMI) funding. Although the administration cancelled the proposed Ebola funding rescission, the House passed legislation to implement the other proposed cuts. The Senate, however, voted not to discharge the bill by the June 22 deadline, so no rescissions took place.

The House passed bipartisan legislation giving shape to more than 50 discrete proposals aimed at addressing the opioid crisis, including language intended to amplify efforts to research and develop non-addictive pain treatments.

Another bipartisan bill pending in the House would repeal the medical device excise tax, which has twice been suspended, the second suspension expiring in 2020. While these serial, two-year suspensions are a welcome reprieve from the unintended consequences of this tax on medical technology innovation, a permanent repeal is the only way to alleviate investment uncertainty and fully restore the pace of medical device progress. The most likely path to passage for this legislation is tax extenders or omnibus legislation.

On July 12, Agency for Healthcare Research and Quality (AHRQ) Director Gopal Khanna met with Research!America and Health IT Coalition member organizations to discuss his goals for the agency and vision for a health care system that leverages advances in IT to maximize the societal return on every health care dollar.  Mr. Khanna said that to maximize its own return, AHRQ must not only fulfill the continuing demand for health services research, but work closely with other health care stakeholders to anticipate and meet the research needs of a rapidly evolving health care system.

Collecting different types of data and expanding the pool of participants should be priorities for migraine clinical trials, according to speakers for the webinar, “The Value of Evidence-Based Treatments for Migraine Sufferers” hosted by Research!America on June 12. The webinar explored advances in migraine research to address gaps in prevention and treatment, development of new therapies, and methods for improving access to care.

One long-neglected area of research has been pediatric migraine. “Ten percent of all kids get migraines,” said Dr. Peter McAllister, medical director, New England Institute for Neurology and Headache, chief medical officer, New England Institute for Clinical Research and Ki Clinical Research. “Up until recently we conducted studies on adults and figured they may work in kids. But that’s changed, fortunately. We have several migraine studies now involving children 6 to 11-years-old.” 

In addition, most clinical trials exclude women and men with comorbid conditions, such as migraine sufferers with fibromyalgia or painful disorders, said Dr. Jan Lewis Brandes, founder, Nashville Neuroscience Group and assistant clinical professor, Department of Neurology, Vanderbilt University School of Medicine. “We need to see how patients with more than one disorder really respond to the medication.”

Researchers should seek information from migraine patients regarding day-to-day tasks, said Dr. Lisa DeLeonardo, licensed psychologist and migraine patient. “I hope there’s a better way to capture more nuanced quality of life data because it’s much more meaningful to patients and to their treating physicians.”

Click here to view a recording of the webinar. 

Trust and collaboration between the general public and the scientific community is vital to maintaining our nation’s global leadership in science and technology. Yet, there is a disconnect between the public and scientists in terms of understanding the societal impact of science, according to a panel of experts at the BIO International Convention in Boston, Massachusetts held on June 6. Seema Kumar, vice president of innovation, global health and policy communication, Johnson & Johnson, moderated the panel.

Our nation’s “science enterprise is at risk if the science community remains essentially invisible to the general public,” said Research!America president and CEO Mary Woolley. “To reinforce trust, and build relationships, communication between the science community and the public must improve,” she added. “It’s up to scientists to be more accountable, to reach out to say, “I work for you” to the public that is paying the bills via their tax, consumer and philanthropic dollars.”  The connection between good health and scientific research must also be made clear to the public, said Dr. Bill Hait, Global Head, Johnson & Johnson External Innovation.

Dr. James Allison, chair of the Department of Immunology at the University of Texas MD Anderson Cancer Center and recipient of the Dr. Paul Janssen Award, said awards help to increase public awareness of the achievements of scientists and scientific progress. Lucia Brown, the 2018 BioGENEius Hall of Fame Recipient, said a lack of diversity in science could also be a factor in public distrust. “When you have individuals who do not look like you at the head of the table, how can you then trust that the research that is being done is actually for you?” Ashanthi De Silva, a rare disease blogger and patient advocate, said the National Institutes of Health’s All of Us Initiative which is gathering data from individuals across different backgrounds to accelerate research could help address the diversity issue.