In a budget proposal sure to spark opposition, the Trump administration has proposed to provide the National Institutes of Health with only $38 billion in fiscal 2021, several billion dollars short of the agency’s funding for the current fiscal year. The proposal also calls for funding of less than $95 billion for the Department of Health and Human Services, a 10% reduction in funding that includes an adjustment for drug pricing proposals and a $5 million cut to FDA monies for the 21st Century Cures Act.
The U.S. House of Representatives passed two spending packages that boosted funds for both the FDA and the NIH, but device and generic drug makers saw other benefits. The House legislation would allow makers of biosimilars and generic drugs to sue brand names for blocking access to the index article, but also repealed the medical device tax, a change that would bolster development of the novel therapies that are the industry’s lifeline. Both spending bills carry numerous provisions related to the health care economy and will go to the Senate for passage, hopefully before the government runs out of money Dec. 20.
Looking to help patients requiring imaging of lungs or other internal structures, researchers from the NIH and Siemens Healthineers AG, of Erlangen, Germany, have developed a high-performance, low magnetic-field magnetic resonance imaging (MRI) system that also could prove safer for those with pacemakers or defibrillators.
Francis Collins, director of the U.S. NIH, said in a public forum that the agency is "really bullish" about precision medicine. However, while precision medicine requires mounds of data, which soon may be available, Collins said the NIH All of Us research program has drawn the interest of more than 300,000 willing participants to date, adding that the target enrollment of 1 million should be accomplished before the end of 2022.
It’s truly a futuristic world we live in with technology that not so long ago was only seen in science fiction. Last year, as part of a three-part series Medical Device Daily published, I explored 3-D printing and the potential for that technology, which enables us to make solid objects from...
When it comes to the National Institutes of Health’s (NIH) funding for medical research, it’s not a matter of truth or consequences. It’s more like truth and unintended consequences. Cheered on by prominent researchers, the NIH has embarked on an all-out campaign to spread the word about the consequences sequestration is having on its ability to fund grants and the long-term impact those consequences are likely to have on the basic research that’s the foundation of drug discovery. The $1.6 billion the NIH expects to lose from its 2013 fiscal budget because of the sequester will translate into a loss...
In the days before the sequester tightened Washington’s belt, the National Institutes of Health (NIH) and several other federal agencies sent up warning shots of just what was at stake. Under the automatic budget cuts intended to put the national deficit on a strict diet, the NIH expected to lose $1.6 billion from its 2013 fiscal budget. If the sequester stayed in place, NIH Director Francis Collins said the agency would give "hundreds and hundreds" fewer grants than it would have awarded otherwise, slowing down important research. Speaking at a news conference, Collins said the NIH was trying to avoid...
Sometimes news comes in bunches. That’s not typically the case in the month of August, which is ordinarily a pretty quiet month. Not this year, though. Here are three stories that stick out, in one case like a sore thumb. Post-market studies for ICD leads FDA announced it will require section 522 studies for a range of ICD leads made by St. Jude Medical. This is not the first time the new FDA has required 522 studies for groups of devices as the 522 orders for surgical meshes, hip implants, and dynamic spinal stabilization systems suggest. I might add that...
As the saying goes, there are things we know we don't know, but here are three things we do know, namely guidances that will affect device makers. One of these might have the effect of making some clinical trials less expensive, but another could put the brakes on provider training even in first-in-human studies unless the sponsor is willing to roll out a training protocol for all physician users in the post-market setting. FDA to put brakes on surgeon training? FDA issued a mid-August draft guidance for device clinical trials indicating antipathy toward a sponsor's training of doctors in...
In this blog, we've explored the issue of NIH funding twice. The first time, we examined the reported fiscal spending numbers (here) and the second time, we examined funding by program areas (here), but now we have the budget/deficit ceiling debate, and yet we still see examples of truly nonsensical arguments about NIH funding. Let's acknowledge at least one thing: It makes no sense to fatten the NIH basic research pipeline when we know FDA can never keep up with it. It's akin to putting up a larger water...
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