The government shutdown hasn’t had any startling affects on rare disease research yet, but drug developers have voiced their concern that it could soon begin to hinder the research process.
Complications with the FDA
Celyad is a Belgium based company working to develop treatments for acute myeloid leukemia, myelodysplastic syndromes, and multiple myeloma as well as an array of other blood cancers. They are currently conducting clinical trials at various sites in the United States, and while they haven’t faced issues yet, they’ve expressed their worries about what complications the shutdown could cause for these investigations.
When clinical trials face roadblocks, it is typical to consult the FDA on how to move forward. If such a complication should arise while the government is shutdown, Ceylad is concerned they won’t receive the feedback they need.
Issues within clinical trials often arise without warning and complications can be unpredictable. At any moment the company may run into a hurdle which requires consultation. If they are not able to receive the information they need, Ceylad says they will be forced to put their trials on hold.
Effects on funding
Presently, the National Institutes of Health (NIH) is the largest funder of biomedical research within the United States. They spend approximately 37 billion dollars each year on research for both rare diseases and more common ailments.
Unfortunately, as a result of the government shutdown- the NIH has had to halt the distribution of new research grants. While they will continue to fund projects currently underway, agencies looking to apply to new grants will not be able to do so.
In essence, this shutdown hasn’t affected the rare community dramatically yet. But if it continues we could be looking at serious setbacks regarding funding of rare disease research as well as current clinical trials.
You can read more about this take on the government shutdown here.
